Investigational peptide pipeline tracker: what's in development 2026

The peptide field's evidence base is asymmetric in two directions. The published literature lags the trial registry by roughly the gap between a primary-endpoint readout and a peer-reviewed paper — typically nine to eighteen months. The practitioner conversation lags both, weighting the molecules with the largest marketing footprint rather than the molecules with the largest active trial programs. The result is a reader stuck between yesterday's literature and tomorrow's drugs, with limited tooling for the in-between layer that actually predicts what the field will look like in two years.

This tracker addresses that middle layer. The page documents peptide programs currently in Phase 1, Phase 2, or Phase 3 development as of mid-2026, or recently read out and awaiting publication, with NCT numbers, sponsor framing, and the principal indication-level question each trial is designed to answer. The framing is descriptive: the page does not predict which programs will succeed or whose Phase 3 readouts will replicate the Phase 2 signals that motivated them. The honest discipline is to cite the registry data, hedge on outcomes, and revisit quarterly.

1. How this tracker works

The pipeline view is a snapshot, not a forecast. Trial readouts shift between Phase 2 and Phase 3 in ways that are not predictable from registry data alone — the failed peptide trials archive catalogues entries where strong Phase 2 signals did not survive larger trials. The corpus's underlying PubMed scanner tracks new publications continuously, but the dossier itself should be reviewed quarterly because the pipeline below is the most rapidly-changing surface on this site.

The canonical primary sources for trial-level information are ClinicalTrials.gov, the EU Clinical Trials Register, and the WHO's International Clinical Trials Registry Platform (ICTRP). NCT numbers are the canonical handle for cross-referencing; this page cites them inline wherever the trial is named. Sponsor pipeline pages (Novo Nordisk, Eli Lilly, Boehringer Ingelheim, Ascendis Pharma, Pfizer, Stealth BioTherapeutics, Palatin Technologies, Altimmune, Neuren Pharmaceuticals) provide complementary commercial framing — useful for cross-checking dose, route, and indication structure, but reflecting the investor-relations register rather than the regulator-grade endpoint analysis that drives approval decisions.

Three editorial notes apply across every entry. First, "currently enrolling" and "completed, awaiting publication" are different evidentiary positions; the page distinguishes between them. Second, the page does not extrapolate from a Phase 2 signal to a Phase 3 outcome; this is the precise inferential mistake that the AOD-9604 METAOD006 entry in the failed-trials archive walks at length. Third, a positive Phase 3 readout does not equal approval; FDA, EMA, and equivalent regulators apply additional review beyond the trial primary, and the gap between topline readout and label is often substantial.

2. Incretin and incretin-combination class

The 2024–2026 window has been dominated by incretin-class expansion. Dual agonists (GLP-1 plus GIP, or GLP-1 plus glucagon), triple agonists, oral formulations, and fixed-dose combinations have produced the largest concentration of late-stage trial readouts in the field's modern history. The class structure has split into three commercial trajectories: the established weekly subcutaneous incretin (semaglutide, tirzepatide), the higher-potency multi-agonist successor (retatrutide, CagriSema, survodutide, mazdutide), and the orally-bioavailable alternative (orforglipron, oral semaglutide, oral amycretin).

Retatrutide (LY3437943) — Eli Lilly's TRIUMPH program

Retatrutide is the GLP-1 / GIP / glucagon triple agonist whose Phase 2 obesity result (Jastreboff et al. 2023) reported 24.2% mean weight loss at 48 weeks on the 12 mg dose — the largest pharmacotherapy-driven weight loss published outside the bariatric-surgery literature. The TRIUMPH Phase 3 program is the most expansive late-stage program for any peptide in the corpus, with seven additional readouts expected through 2026 across obesity, type 2 diabetes, osteoarthritis, obstructive sleep apnea, MASLD, and cardiovascular outcomes (Lilly investor relations TRIUMPH overview).

• TRIUMPH-1 (NCT05929066) — obesity in adults with body mass index ≥30, or ≥27 with weight-related complications, without type 2 diabetes; an 80-week design with primary endpoint percent weight change at week 80. Topline readout expected 2026.
• TRIUMPH-2 (NCT05929079) — obesity or overweight in adults with type 2 diabetes; same 80-week structure with HbA1c and weight co-primaries.
• TRIUMPH-3 (NCT05882045) — obesity in adults with established cardiovascular disease; a higher-risk population that provides interim safety data for the cardiovascular label that TRIUMPH-Outcomes will eventually anchor.
• TRIUMPH-4 (NCT05931367) — obesity in adults with knee osteoarthritis. Topline released December 2025 (Lilly press release, December 2025): 28.7% mean weight reduction at 68 weeks on the 12 mg dose, with concurrent improvement in WOMAC pain scores. This is the first Phase 3 readout published from the program and is the trial that triggered the global regulatory submissions Lilly has signaled.
• TRIUMPH-5 (NCT06662383) — head-to-head retatrutide versus tirzepatide in adults with obesity, the most clinically informative comparison in the class. Active.
• TRIUMPH-Outcomes (NCT06383390) — the event-driven cardiovascular and kidney outcomes trial; approximately 10,000 participants with body mass index ≥27 plus established atherosclerotic cardiovascular disease or chronic kidney disease, primary outcome major adverse cardiovascular events. Expected to run approximately five years.

The honest framing for retatrutide in 2026 is that the molecule has produced the highest published efficacy signal in the class at the Phase 2 level and one positive Phase 3 readout in a specialized population (obesity plus knee OA). Whether the headline 24–28% weight-loss number replicates across the broader obesity population, and whether the chronotropic safety signal flagged in the Phase 2 obesity and T2D programs scales acceptably at the 80-week Phase 3 duration, are the open questions the TRIUMPH-1 and TRIUMPH-2 readouts will answer. The retatrutide peptide page walks the underlying mechanism; the fat loss decision guide places the molecule relative to the rest of the class.

CagriSema and cagrilintide — Novo Nordisk's REDEFINE program

Cagrilintide is the amylin-receptor agonist Novo Nordisk co-formulates with semaglutide as CagriSema. The REDEFINE Phase 3 program (Garvey et al., NEJM 2025; Davies et al., NEJM 2025) is the most-watched obesity-pharmacology readout of the past eighteen months and the one whose interpretation is genuinely contested.

• REDEFINE-1 (n=3,417) — readout December 20, 2024. CagriSema produced −22.7% mean weight loss at 68 weeks under the trial-product estimand and −20.4% under the treatment-policy estimand in adults with obesity without diabetes. Below Novo Nordisk's stated 25% target, with the stock dropping roughly 20–26% over two sessions following the topline release (CagriSema REDEFINE-1 press release, December 2024).
• REDEFINE-2 (n=1,206) — adults with obesity and type 2 diabetes. Weight reduction was 13.7% on CagriSema versus 3.4% on placebo, with 73.5% of CagriSema participants achieving HbA1c ≤6.5%.
• REDEFINE-3 / REDEFINE-CVOT (NCT05669755) — the cardiovascular outcomes trial in approximately 7,000 adults with obesity and established cardiovascular disease, with three-point major adverse cardiovascular events as the primary outcome. Event-driven and ongoing.
• REDEFINE-4 — the open-label head-to-head trial against tirzepatide; reported 23% mean weight loss on CagriSema but did not meet its prespecified non-inferiority primary endpoint. The result is part of the broader pattern that the CagriSema-versus-tirzepatide commercial positioning has not yet been resolved by trial data favorable to either side.

Novo Nordisk filed the CagriSema New Drug Application with the FDA in 2025. The cagrilintide peptide page walks the trial design, the trial-product-versus-treatment-policy estimand framing, and the contested interpretation of the REDEFINE-1 magnitude.

Survodutide (BI 456906) — Boehringer Ingelheim / Zealand Pharma

Survodutide is a GLP-1 / glucagon dual agonist with active Phase 3 programs in obesity and MASH plus a cardiovascular outcomes program. The SYNCHRONIZE obesity program (NCT06066528, NCT06066515) and the LIVERAGE MASH program both initiated in 2024.

• SYNCHRONIZE-1 (NCT06066515) — adults with obesity without type 2 diabetes; 76 weeks of treatment, randomization to survodutide titrated to 3.6 or 6.0 mg subcutaneous weekly versus placebo. Baseline characteristics published in late 2025 (SYNCHRONIZE-1 baseline characteristics, PubMed 41187967).
• SYNCHRONIZE-CVOT — global long-term cardiovascular safety study in adults with obesity plus cardiovascular disease, chronic kidney disease, or cardiovascular risk factors. (SYNCHRONIZE-CVOT design paper, Hagström et al. JACC: Heart Failure 2024).
• LIVERAGE (event-driven, n≈1,800) — MASH with moderate-to-advanced fibrosis (stages F2–F3) in non-cirrhotic adults; 52-week histology endpoint plus seven-year liver-event outcome (LIVERAGE Phase 3 design poster, EASL 2025).
• LIVERAGE-Cirrhosis (n≈1,590) — adults with MASH and compensated cirrhosis (fibrosis stage F4); event-driven endpoint over approximately 4.5 years.

The FDA granted survodutide Breakthrough Therapy designation for non-cirrhotic MASH with moderate-to-advanced fibrosis in 2024. The Phase 2 MASH readout (Sanyal et al. 2024) reported MASH resolution without fibrosis worsening in 47% of the 4.8 mg arm versus 14% of placebo, providing the Phase 3 mechanistic basis. The hepatic fat decision guide walks the broader MASH pharmacology landscape.

Mazdutide (LY3305677) — Eli Lilly / Innovent in China

Mazdutide is a GLP-1 / glucagon dual agonist developed by Innovent under license from Lilly, principally for the Chinese market. The Phase 3 program (GLORY-1 and GLORY-2) read out in 2024–2025.

• GLORY-1 — 32-week Phase 3 in Chinese adults with overweight or obesity, published in NEJM 2025 (Ji et al. 2025). Weight change −10.09% on 4 mg, −12.55% on 6 mg, +0.45% on placebo. 73.9% on 4 mg and 82.0% on 6 mg achieved ≥5% weight reduction versus 10.5% on placebo.
• GLORY-2 — 60-week Phase 3 with the 9 mg dose. Non-diabetic subgroup achieved 20.08% mean weight loss versus 2.81% on placebo (GLORY-2 press release, October 2025).

Mazdutide received NMPA (China) approval for chronic weight management in June 2025 (Innovent / NMPA approval, June 2025), making it the first dual GCG/GLP-1 receptor agonist approved for chronic weight management in any major jurisdiction.

Ecnoglutide (XW003) — Sciwind Biosciences

Ecnoglutide is a long-acting, cAMP-signaling-biased GLP-1 analog developed in China. The Phase 3 weight-management program in Chinese adults read out 15.4% mean weight loss at 48 weeks on the 2.4 mg dose (placebo-adjusted 15.1%), with 92.8% of participants achieving ≥5% weight loss (Ji et al., Lancet Diabetes Endocrinol 2025). The molecule received NMPA approval for chronic weight management in Chinese adults in March 2026 (Sciwind ecnoglutide approval, March 2026), the world's first approved cAMP-biased GLP-1 receptor agonist for weight management.

Orforglipron — Eli Lilly's oral small-molecule GLP-1

Orforglipron is technically a non-peptide small-molecule GLP-1 receptor agonist (peptide-adjacent rather than strictly a peptide), included here because the molecule occupies the oral-GLP-1 commercial position that competes directly with the injectable peptide class. The ACHIEVE Phase 3 program in type 2 diabetes read out positive across multiple trials in 2025.

• ACHIEVE-1 (T2D, drug-naive) — published in NEJM 2025 (Frias et al., NEJM 2025). HbA1c reduction 1.3% to 1.6% versus placebo at 40 weeks.
• ACHIEVE-2 (T2D, on metformin) — positive topline October 2025.
• ACHIEVE-5 (T2D, plus insulin glargine) — positive topline October 2025; HbA1c reduction of 2.1% versus placebo.
• ATTAIN-1 (obesity) — published in NEJM 2025; meaningful weight loss and cardiometabolic improvements consistent with the injectable GLP-1 class.
• ATTAIN-2 (obesity with T2D) — published in The Lancet 2025 (Aronne et al., Lancet 2025).

Lilly has signaled regulatory submission for type 2 diabetes in 2026 and for obesity by year-end 2025. The safety profile reported in ACHIEVE-1 is consistent with the injectable GLP-1 class — predominantly gastrointestinal adverse events, mild to moderate.

Amycretin — Novo Nordisk's next-generation unimolecular GLP-1 + amylin agonist

Amycretin is a unimolecular agonist of both GLP-1 and amylin receptors, advanced as Novo Nordisk's response to the cagrilintide-plus-semaglutide combination strategy by collapsing both mechanisms into a single molecule. The Phase 1b/2a readout published in The Lancet 2025 (Knop et al., Lancet 2025) reported up to 14.5% weight loss on the subcutaneous formulation at 36 weeks versus 2.6% on placebo, and up to 10.1% on the oral formulation. Both formulations are advancing to Phase 3 with initiation planned for Q1 2026 (Novo Nordisk amycretin advancement announcement, June 2025).

Pemvidutide (ALT-801) — Altimmune

Pemvidutide is a GLP-1 / glucagon dual agonist with a primary focus on MASH and a secondary obesity indication. The IMPACT Phase 2b in MASH read out in two parts:

• 24-week (June 2025) — 212 participants with biopsy-confirmed MASH and F2/F3 fibrosis, randomized 1:1:1 to pemvidutide 1.2 mg, 1.8 mg, or placebo. MASH resolution without fibrosis worsening in up to 59.1%; weight loss 5.0% to 6.2% versus 1.0% on placebo (IMPACT 24-week topline, June 2025).
• 48-week (December 2025) — sustained weight loss of 4.5% on 1.2 mg and 7.5% on 1.8 mg versus 0.2% on placebo; liver fat reduction 45.2% and 54.7% versus 8.2% on placebo; ELF score and liver stiffness measure improvements in 27.8% and 32.4% of the active arms versus 3.2% on placebo (IMPACT 48-week topline, December 2025).

Altimmune held an end-of-Phase-2 meeting with FDA and aligned on a registrational Phase 3 design for MASH in moderate-to-advanced fibrosis. Phase 3 initiation is the operational next step.

Efinopegdutide (MK-6024) — Merck / Hanmi

Efinopegdutide is a GLP-1 / glucagon dual agonist initially developed by Hanmi Pharmaceutical and licensed to Merck. The Phase 2a readout in NAFLD (Romero-Gómez et al., J Hepatol 2023) reported 72.7% liver fat reduction at 24 weeks on 10 mg weekly versus 42.3% on semaglutide 1 mg. The molecule advanced to a Phase 2b in pre-cirrhotic NASH (NCT04944992, ~300 participants over approximately 70 weeks) and a Phase 2 in compensated cirrhosis due to steatohepatitis (NCT06465186).

Bimagrumab — Eli Lilly (Versanis)

Bimagrumab is an anti-ActRIIB monoclonal antibody, included here as a peptide-adjacent injectable that combines with GLP-1 receptor agonists to address the lean-mass loss that the incretin class produces. The BELIEVE Phase 2 in obesity (NCT05616013, n=507) reported 22.1% weight loss at 72 weeks on bimagrumab 30 mg/kg plus semaglutide 2.4 mg, with 92.8% of weight loss from fat mass and lean-mass loss limited to 2.9% compared with 7.4% on semaglutide monotherapy (Bimagrumab BELIEVE Phase 2, Nature Medicine 2026). The obesity-only Phase 3 trial continues; the obesity-plus-T2D arm was discontinued in 2025 for stated strategic-business reasons. Bimagrumab is the most-watched class in the muscle-sparing-incretin-adjacent space; the broader muscle preservation decision guide addresses the underlying lean-mass question.

Tirzepatide expansion — SURPASS-CVOT, SURMOUNT-OSA, SUMMIT

Tirzepatide is approved for type 2 diabetes (Mounjaro) and obesity (Zepbound); the active development program centers on label expansion and cardiovascular outcomes.

• SURPASS-CVOT (NCT04255433) — published in NEJM December 2025 (Nicholls et al. 2025). Head-to-head against dulaglutide in 13,000+ adults with type 2 diabetes and atherosclerotic cardiovascular disease over a median of 4 years. Tirzepatide met non-inferiority for the three-point MACE primary (12.2% vs 13.1%, P=0.003 non-inferiority, P=0.09 superiority); the expanded MACE composite (CV death, MI, stroke, or coronary revascularization) favored tirzepatide significantly. All-cause mortality 16% lower on tirzepatide.
• SURMOUNT-OSA — published in NEJM 2024 (Malhotra et al., NEJM 2024). Apnea-Hypopnea Index reduction of 25.3 events per hour with tirzepatide versus 5.3 on placebo at 52 weeks. The FDA approved tirzepatide as the first prescription medication for moderate-to-severe obstructive sleep apnea with obesity in December 2024.
• SUMMIT — published in NEJM November 2024 (Packer et al., NEJM 2025). HFpEF (LVEF ≥50%) with obesity; 38% reduction in cardiovascular death or worsening heart failure. The heart failure and peptides dossier treats SUMMIT in detail.

3. GH-axis and growth-hormone class

The GH-axis class in 2026 is dominated by long-acting weekly somatropin analogs displacing daily growth hormone replacement, not by novel mechanism. Three molecules occupy the weekly somatropin commercial position; the development question is label expansion across pediatric and adult populations rather than new pharmacology.

• Lonapegsomatropin (Skytrofa, TransCon-hGH) — Ascendis Pharma. FDA-approved for pediatric GH deficiency in 2021. The foresiGHt Phase 3 (NCT04615273, n=259) supported FDA approval for adult GHD in 2024, with statistically significant reductions in trunk fat and increases in lean body mass at week 38 versus placebo, and a safety profile similar to daily somatropin (Ascendis foresiGHt FDA approval, 2024). Active label-expansion work continues.
• Somapacitan (Sogroya) — Novo Nordisk. FDA-approved for adult GHD in 2020 and pediatric GHD in 2023. The REAL8 Phase 3 basket trial readout (May 2025) covered four pediatric growth disorders simultaneously — small for gestational age, Turner syndrome, Noonan syndrome, and idiopathic short stature — under a single trial protocol, an innovative design that has not previously been deployed in the growth-disorder space. Once-weekly somapacitan was non-inferior or superior to daily growth hormone across the included indications (Novo Nordisk REAL8 readout, May 2025).
• Somatrogon (Ngenla) — Pfizer / OPKO. FDA-approved for pediatric GH deficiency in June 2023, based on a Phase 3 (NCT02968004, n=224) that met its non-inferiority primary against daily somatropin. The gh-axis dossier covers the broader GH-axis question and the tesamorelin entry addresses GHRH-axis-specific pharmacology.

The peptide-adjacent question on the GH-axis pipeline is whether the practitioner-targeted GH-secretagogue class (CJC-1295 with DAC, ipamorelin, sermorelin, hexarelin) progresses to any pivotal trial in 2026. As of mid-2026, no Phase 3 RCT of any of these molecules in any indication is registered or active. The clinical-development gap is itself the load-bearing observation; the GH secretagogue discontinuation playbook addresses the implications for chronic users.

4. Cardiovascular and metabolic outcomes class

The peptide-cardiovascular pipeline in 2026 is dominated by GLP-1-class outcomes trials, where the question is no longer whether incretin therapy provides cardiovascular benefit (SELECT, LEADER, SUSTAIN-6, SUMMIT, and SURPASS-CVOT have answered that for the approved molecules) but whether the next-generation multi-agonists deliver larger or more durable benefit, and whether the benefit extends to populations beyond those captured by the existing trial envelope.

• SELECT extension and longitudinal analyses (Lincoff et al. 2023) — the 17,604-participant SELECT trial established that semaglutide 2.4 mg reduces three-point MACE by 20% in adults with overweight or obesity and cardiovascular disease without diabetes. Prespecified secondary analyses through 2025 (SELECT adiposity prespecified analysis, Lancet 2025) reported the cardioprotective effect was largely independent of weight loss, with the difference emerging within months of treatment initiation — earlier than weight-loss-mediated mechanisms would predict.
• REDEFINE-CVOT (NCT05669755) — the 7,000-participant CagriSema cardiovascular outcomes trial. Active, event-driven.
• TRIUMPH-Outcomes (NCT06383390) — the 10,000-participant retatrutide cardiovascular and kidney outcomes trial. Active.
• SYNCHRONIZE-CVOT — the survodutide cardiovascular outcomes trial. Active.
• CORALreef (Merck's MK-0616 / enlicitide decanoate) — not strictly incretin-class but the first Phase 3 program for an oral PCSK9 macrocyclic peptide inhibitor. Three trials enrolling approximately 17,000 participants total, with CORALreef Lipids reporting 47.6% sustained LDL-C reduction at one year versus placebo (Merck CORALreef Lipids topline, 2025) and parallel positive readouts in HeFH and AddOn populations. CORALreef Outcomes is the cardiovascular outcomes arm.

The honest framing for the cardiovascular pipeline is that the next clinically informative readouts are TRIUMPH-Outcomes (does retatrutide's triple-agonist mechanism produce CV benefit at least equivalent to semaglutide's, and is the magnitude additive or substitutive?), REDEFINE-CVOT (does the amylin-plus-GLP-1 combination produce additive benefit beyond semaglutide alone?), and SYNCHRONIZE-CVOT (does GLP-1 / glucagon dual agonism replicate the GLP-1 monotherapy benefit?). All three are event-driven and multi-year, with readouts expected in the late-2020s window. The heart failure and peptides dossier and the GLP-1 receptor pharmacology dossier address the underlying mechanistic landscape.

5. Neurology class

The neurology pipeline in 2026 is shaped by two converging readouts. The negative Phase 3 EVOKE / EVOKE+ semaglutide trials in early Alzheimer's disease (announced November 24, 2025) closed the door on GLP-1 monotherapy for symptomatic Alzheimer's, redirecting the field toward combination hypotheses with the anti-amyloid antibodies. The Phase 2 LIXIPARK lixisenatide trial in early Parkinson's (positive on motor primary, published 2024) opened a parallel mechanism question for Parkinson's that remains open.

• EVOKE (NCT04777396) and EVOKE+ (NCT04777409) — Novo Nordisk Phase 3 of once-daily oral semaglutide 14 mg in 3,808 adults aged 55–85 with mild cognitive impairment or mild dementia due to Alzheimer's disease and confirmed amyloid positivity. Primary endpoint Clinical Dementia Rating Sum of Boxes at 104 weeks. Topline November 2025: neither trial demonstrated superiority over placebo on the primary endpoint despite improvements in disease-associated biomarkers. The one-year extension was discontinued (Novo Nordisk EVOKE / EVOKE+ topline, November 2025). The failed peptide trials archive treats EVOKE / EVOKE+ as the modern reference negative trial for the GLP-1 / cognitive decline hypothesis.
• LIXIPARK (NCT03439943) — investigator-initiated Phase 2 of lixisenatide in 156 adults with early Parkinson's disease across 22 French centers, published in NEJM 2024 (Meissner et al. 2024). Lixisenatide arm showed less motor-symptom progression on MDS-UPDRS Part 3 than placebo at 12 months (treatment difference 3.08 points). Gastrointestinal adverse events were prominent (46% nausea, 13% vomiting). No Phase 3 confirmatory trial of lixisenatide in Parkinson's has been initiated as of 2026; the broader GLP-1 / Parkinson's question advances through other molecules.
• ELAD liraglutide Alzheimer's trial — Phase 2b investigator-initiated trial in 204 UK patients with mild-to-moderate Alzheimer's, primary endpoint 18F-FDG PET cerebral glucose metabolism, published in Nature Medicine 2026 (Edison et al. 2026). Primary endpoint missed; secondary endpoints on brain atrophy and ADAS-Exec cognitive decline reached significance. The failed peptide trials archive and the Alzheimer's and peptides dossier walk the trial in detail.
• NNZ-2591 (Neuren Pharmaceuticals) — cyclic-GPE analog for rare neurodevelopmental disorders. The Phase 3 in Phelan-McDermid syndrome (registered, first patient dosed) is the first-ever Phase 3 trial in PMS — approximately 160 children aged 3–12, 13-week treatment with co-primary endpoints on the Vineland Adaptive Behavior Scales Receptive Communication sub-domain and the PMS Assessment of Change (Neuren Phase 3 first-patient-dosed announcement). Phase 2 trials in Pitt-Hopkins, Angelman, and Phelan-McDermid syndromes have read out positive on smaller samples; the Phase 3 confirmation is the load-bearing test.
• Trofinetide (Daybue) — Acadia Pharmaceuticals. FDA-approved for Rett syndrome in 2023; DAYBUE STIX powder formulation approved December 2025. No active Phase 3 program for trofinetide in Fragile X syndrome as of 2026; the previous Phase 2 was positive but did not progress to a registrational Phase 3.
• Cerebrolysin (EVER Neuro Pharma) — porcine-brain-derived peptide mixture, approved in 50+ countries for stroke and TBI indications. The CASTA confirmatory Phase 3 in acute ischemic stroke was negative (Heiss et al. 2012) and the Cochrane synthesis (Ziganshina et al. 2023) concluded "probably has little or no beneficial effect" on all-cause mortality in acute ischemic stroke. Ongoing observational and registry studies in Asia and Eastern Europe in 2024–2026 do not displace the Cochrane reading. No new Phase 3 of Cerebrolysin in a Western trial network is active.
• ARA-290 / cibinetide (Araim Pharmaceuticals) — 11-amino-acid innate-repair-receptor agonist derived from the EPO B-helix. The Phase 2 readouts in sarcoidosis-related small-fiber neuropathy (Heij et al. 2012; Dahan et al. 2013) were positive on corneal-nerve-fiber-area and intraepidermal nerve-fiber-length endpoints. No active Phase 3 registered as of 2026; the ARA-290 peptide page walks the program status.

The Parkinson's and peptides dossier and the Alzheimer's and peptides dossier address the neurology landscape in detail. The honest 2026 reading is that the GLP-1 / cognitive-decline hypothesis at monotherapy doses is closed for symptomatic Alzheimer's, open for preclinical or preventive Alzheimer's populations, and unresolved for Parkinson's disease where the LIXIPARK signal has not yet been Phase 3 confirmed.

6. Mitochondrial and rare-disease class

The September 2025 FDA accelerated approval of elamipretide (Forzinity, SS-31) for Barth syndrome reopened the rare-disease pathway for mitochondrial peptide therapeutics. Forzinity is the first approved mitochondria-targeted therapy and the first treatment of any kind for Barth syndrome (Stealth BioTherapeutics Forzinity FDA approval, September 19, 2025). The approval covers patients weighing at least 30 kg and is based on the TAZPOWER trial's knee extensor muscle-strength endpoint.

The label-expansion pathway for elamipretide is now the active development question. Stealth has signaled ongoing work in dry age-related macular degeneration (following the ReCLAIM-2 Phase 2 that missed clinical-functional primaries but produced significant structural-biomarker secondaries; Ehlers et al. 2024) and continued exploration of additional mitochondrial indications. The MMPOWER-3 primary mitochondrial myopathy pivotal was negative on its prespecified primaries (Karaa et al. 2023); the subgroup-driven NuPOWER follow-up has not produced public readouts as of mid-2026. The mitochondrial peptides dossier walks the broader class.

The wider mitochondrial-peptide pipeline is thin. MOTS-c has produced biomarker-cohort evidence in human ischemia-reperfusion (Peng et al. 2026) but no exogenous-administration human trial. The class remains predominantly preclinical at the human-trial level.

7. Sexual function class

The sexual function pipeline is limited and centers on melanocortin-pathway and kisspeptin-pathway molecules.

• PT-141 / bremelanotide (Vyleesi) — Palatin Technologies. Approved 2019 for hypoactive sexual desire disorder in premenopausal women. Palatin announced plans for a Phase 3 trial of co-formulated bremelanotide plus PDE5 inhibitor in PDE5i-nonresponsive erectile dysfunction starting in 2025; a Phase 2b of subcutaneous bremelanotide co-formulated with a PDE5 inhibitor is currently active. Male HSDD remains an off-label use without Phase 3 evidence. The PT-141 peptide page walks the indication landscape.
• Kisspeptin-54 — Imperial College London. The Hammersmith Hospital group has run multiple investigator-initiated trials of kisspeptin-54 as an alternative trigger for oocyte maturation in IVF, particularly in women with PCOS at high risk of ovarian hyperstimulation syndrome. The published Phase 2 work (Abbara et al. 2017) reported no cases of clinically significant OHSS at the best-performing dose in PCOS-IVF patients. Phase 3 commercial development by an industrial sponsor has not been initiated as of 2026; the work remains investigator-initiated. The kisspeptin peptide page walks the broader program.

8. Immune and long-COVID class

The immune-peptide pipeline in 2026 is heterogeneous and lower-stakes than the metabolic / cardiovascular surface, with most active programs at the Phase 2 or investigator-initiated level rather than sponsor-led pivotal.

• Thymosin α-1 (thymalfasin / Zadaxin) — multiple ongoing investigator-initiated trials in long COVID / PASC (Minutolo et al. 2023), hepatitis B and C, and adjunctive cancer indications. The Chinese expert consensus on Tα1 clinical application published in 2025 (Expert Consensus on Tα1 clinical application, Infectious Microbes & Diseases 2025) consolidated the indication-by-indication evidence. No FDA-aligned Phase 3 active. The thymosin α-1 peptide page and the long COVID and peptides dossier address the program landscape.
• Aviptadil (ZYESAMI, RLF-100) — vasoactive intestinal peptide synthetic, originally developed for respiratory failure in COVID-19. The Phase 2b/3 program in critical COVID-19 reported primary-endpoint success but did not receive FDA Emergency Use Authorization. An inhaled formulation for pulmonary sarcoidosis received FDA Orphan Drug designation in 2021 with subsequent Phase 2 development in Europe. No active Phase 3 in long COVID or PASC.
• ARA-290 / cibinetide — see Neurology section. The sarcoidosis-related neuropathy program intersects with the immune class through innate-repair-receptor activation rather than classical adaptive-immune modulation.

9. Gastrointestinal and mucosal class

• Teduglutide (Gattex / Revestive) — Takeda. FDA-approved for adult short bowel syndrome and for pediatric SBS in patients ≥1 year (2019 label expansion). No new pivotal program active in 2026; the teduglutide peptide page walks the established indication landscape.
• Apraglutide — Ironwood Pharmaceuticals (following the 2023 VectivBio acquisition). The STARS Phase 3 (NCT04627025) in short bowel syndrome with intestinal failure reported significant reduction in parenteral support volume and 6.4% achieving total enteral autonomy at week 24 versus 0% on placebo (Iyer et al., Intestinal Failure Journal 2025). Ironwood expected US regulatory submission Q1 2025 — apraglutide is the first once-weekly GLP-2 analog to demonstrate efficacy at Phase 3 scale.
• Larazotide (AT-1001) — the CeDLara Phase 3 in non-responsive celiac disease was discontinued for futility in June 2022 by 9 Meters Biopharma after the interim analysis showed the additional sample size needed to detect a treatment effect was too large to justify continuation (CeDLara discontinuation, June 2022). No active sponsor program for larazotide in 2026. The larazotide peptide page walks the trial history.

10. Pattern observations

Five patterns recur across the 2026 pipeline data. Each has methodological implications for reading the readouts that follow.

First, the 2024–2026 window is the most concentrated incretin-class development period in pharmacology history. Within a 24-month window, the field has read out CagriSema REDEFINE (Phase 3, contested magnitude), retatrutide TRIUMPH-4 (Phase 3, positive), tirzepatide SUMMIT (Phase 3, positive in HFpEF), tirzepatide SURMOUNT-OSA (Phase 3, positive), tirzepatide SURPASS-CVOT (Phase 3, positive on non-inferiority), mazdutide GLORY-1 and GLORY-2 (Phase 3, positive in China), ecnoglutide Phase 3 (positive in China, NMPA-approved), orforglipron ACHIEVE-1, 2, and 5 and ATTAIN-1 and 2 (Phase 3, positive), amycretin Phase 1b/2a (positive, advancing to Phase 3), and pemvidutide IMPACT 24- and 48-week (Phase 2b, positive). The accumulated 2024–2026 incretin-class evidence base is larger than the entire preceding decade. The next-generation differentiation question — whether the multi-agonist mechanisms produce additive cardiovascular and metabolic benefit beyond GLP-1 monotherapy, or whether the additional receptor agonism is largely captured by greater weight loss — is the load-bearing scientific question and is what TRIUMPH-Outcomes and REDEFINE-CVOT will answer.

Second, the negative results matter. EVOKE / EVOKE+ closed the GLP-1 / symptomatic Alzheimer's question at monotherapy doses. The CagriSema REDEFINE-1 readout was below sponsor expectations and below the tirzepatide Phase 3 envelope, producing a stock-market dislocation that reflects how high the bar has been set by the incremental Phase 2 retatrutide signal. The failed peptide trials archive walks the broader pattern: Phase 2 signals do not always survive Phase 3 confirmation, and the pipeline forecasts that overweight the Phase 2 readouts are systematically too optimistic.

Third, the GH-axis pipeline has converged on weekly long-acting somatropin analogs and away from novel mechanism. Lonapegsomatropin, somapacitan, and somatrogon are the three commercial entrants; the active development question is label expansion across pediatric and adult populations rather than receptor-level innovation. The biohacker-targeted GH-secretagogue class (CJC-1295, ipamorelin, sermorelin, hexarelin) remains without any Phase 3 program in any indication.

Fourth, the rare-disease pathway is more productive than the general-population pathway for several peptide mechanisms. The September 2025 elamipretide approval for Barth syndrome (approximately 150 diagnosed patients in the United States) succeeded after the same molecule's primary mitochondrial myopathy pivotal and dry-AMD trial missed their prespecified primaries. The NNZ-2591 program in Phelan-McDermid syndrome and the trofinetide approval for Rett syndrome follow the same pattern: rare-disease populations with tight mechanism-phenotype mapping produce regulator-ready signals where the same molecules in heterogeneous disease populations do not.

Fifth, China has emerged as a parallel regulatory pathway for the incretin class. Mazdutide is the first dual GCG/GLP-1 receptor agonist approved for weight management in any major jurisdiction (NMPA, June 2025), and ecnoglutide is the first cAMP-biased GLP-1 receptor agonist approved for weight management (NMPA, March 2026). The Chinese pathway is shorter and faster than the FDA pathway for incretin-class molecules, with implications for global commercial competition that the Western pipeline analyses have not yet fully absorbed.

11. What this tracker is not

The page does not predict approval outcomes. The transition from positive Phase 3 readout to FDA or EMA label includes review of statistical analysis plans, safety database adequacy, manufacturing inspection, advisory committee review, and post-marketing commitment negotiation; the gap between topline readout and approval is typically 12–24 months and approvals do not follow automatically. The CagriSema REDEFINE-1 readout in December 2024 was below sponsor expectations on magnitude but met statistical superiority on the primary; the FDA submission and approval question is distinct from the trial-success question.

The page does not catalogue every active investigational trial. Inclusion criteria favor sponsor-led pivotal programs and investigator-initiated trials with published primary readouts. Early-phase exploratory trials, dose-finding studies, and pharmacokinetic-only trials are not enumerated; this is an editorial choice to keep the page useful as a navigation surface rather than a complete trial registry, which ClinicalTrials.gov already provides.

The page is not a replacement for primary trial-registry data. NCT numbers are the canonical handles; this dossier cites them but does not duplicate the registry's design summary, eligibility criteria, and outcome measure detail. Readers using the page for decision-relevant work should pull the trial record from ClinicalTrials.gov directly for the design-level detail.

12. Tracking discipline

The pipeline below the headline level changes monthly. The discipline for keeping this tracker accurate has three parts.

First, quarterly review. The page should be re-read against ClinicalTrials.gov and the sponsor pipeline pages at the start of each quarter, with topline updates flagged for editorial decision and the "currently enrolling" / "completed, awaiting publication" categorizations refreshed.

Second, primary-source priority. Sponsor press releases use commercial framing; primary trial-registry data and peer-reviewed publications use regulatory framing. When the two diverge — sponsor describes a result as "positive" when the regulator framing would describe it as "missed-primary-positive-secondaries" — the regulatory framing is the editorial default on this page. The failed peptide trials archive walks several examples where the framing distinction matters.

Third, honest hedging on outcome prediction. Trials that have not read out cannot be predicted from Phase 2 data alone; molecules that have read out positive at Phase 3 cannot be assumed to have FDA approval; FDA approval does not extend to populations outside the trial design's enrolled phenotype. The page cites trial design and readout status; it does not extrapolate.

Sources cited

• Jastreboff et al. 2023 — retatrutide Phase 2 in obesity
• Rosenstock et al. 2023 — retatrutide Phase 2 in T2D
• Sanyal et al. 2024 — retatrutide Phase 2a in MASLD
• Pillai et al. 2026 — retatrutide CKM review
• Karaa et al. 2023 — MMPOWER-3 elamipretide PMM Phase 3
• Ehlers et al. 2024 — ReCLAIM-2 elamipretide dry AMD
• Thompson 2021 — elamipretide Barth syndrome
• Edison et al. 2026 — ELAD liraglutide Alzheimer's Phase 2b
• Heiss et al. 2012 — CASTA Cerebrolysin acute ischemic stroke
• Ziganshina et al. 2023 — Cochrane Cerebrolysin acute stroke synthesis
• Heij et al. 2012 — ARA-290 sarcoidosis SFN pilot
• Dahan et al. 2013 — Cibinetide sarcoidosis SFN
• Peng et al. 2026 — MOTS-c myocardial ischemia-reperfusion cohort
• Minutolo et al. 2023 — thymosin α-1 PASC
• Abbara et al. 2017 — kisspeptin-54 in IVF
• Lincoff et al. 2023 — SELECT semaglutide CV outcomes