New Peptide Drugs in FDA Pipeline (2026-2028)
**The FDA approved four peptide and oligonucleotide drugs in 2024 and 46 novel drugs overall in 2025.** The next three years promise a wave of peptide approvals that could reshape obesity treatment, autoimmune disease management, and cancer care.
The FDA approved four peptide and oligonucleotide drugs in 2024 and 46 novel drugs overall in 2025. The next three years promise a wave of peptide approvals that could reshape obesity treatment, autoimmune disease management, and cancer care. Here is a comprehensive look at the peptide drugs closest to market, the clinical trials that will determine their fate, and the therapeutic areas where peptides are making the biggest impact.
Table of Contents
- The Current State of Peptide Drug Development
- Drugs Under FDA Review (Decision Expected 2026)
- Phase 3 Candidates Approaching FDA Submission
- Emerging Phase 2/3 Candidates (2027-2028 Window)
- Therapeutic Areas to Watch
- Key Clinical Trials to Follow in 2026
- The Regulatory Environment
- FAQ
- The Bottom Line
- References
The Current State of Peptide Drug Development
Over 80 peptide therapeutics have been approved globally. More than 170 peptide molecules are in active clinical trials. The FDA has approved an increasing number of peptide-based drugs over the past five years, with the pace accelerating as GLP-1 agonists proved the commercial viability of peptide drugs.
In 2024, the FDA approved two peptide drugs among its 50 novel drug approvals. In 2025, 46 novel drugs were approved, with half targeting orphan (rare disease) indications — a trend that favors peptides, given their high specificity and suitability for targeted therapy.
The pipeline for 2026-2028 is dominated by metabolic disease (obesity, diabetes, NASH/MASLD), but also includes candidates in autoimmune disease, oncology, and cardiovascular medicine.
Drugs Under FDA Review (Decision Expected 2026)
These peptide and peptide-related drugs are currently under FDA review, with decisions expected in 2026.
1. High-Dose Semaglutide 7.2 mg (Novo Nordisk)
Type: GLP-1 receptor agonist peptide Indication: Obesity and overweight FDA Submission: November 2025 (under CMPV pilot program) Expected Decision: Q1 2026
Novo Nordisk submitted a higher-dose version of injectable semaglutide — 7.2 mg versus the current maximum of 2.4 mg — for weight management. The higher dose is expected to produce greater weight loss, potentially narrowing the efficacy gap with tirzepatide.
What to watch: Whether the incremental weight loss from 7.2 mg versus 2.4 mg is large enough to meaningfully change the competitive dynamic. Side effect profiles at the higher dose will also be closely scrutinized.
2. Orforglipron (Eli Lilly)
Type: Oral non-peptide GLP-1 receptor agonist (small molecule) Indication: Obesity and type 2 diabetes FDA Review: Underway Expected Decision: Mid-2026
Orforglipron is not technically a peptide — it is a small molecule that mimics peptide GLP-1 activity. But it is the most direct competitor to oral semaglutide and will reshape the oral GLP-1 market if approved.
In the Phase 3 ATTAIN-1 trial, orforglipron produced approximately 14.7% body weight loss in adults with obesity without diabetes. Leerink analysts expect approval in Q2 2026.
What to watch: As a small molecule, orforglipron is cheaper and simpler to manufacture than peptide-based oral GLP-1s. If approved at a competitive price point (expected $149/month starting dose under the TrumpRx agreement), it could quickly capture significant market share.
3. Icotrokinra (Johnson & Johnson)
Type: Oral targeted cyclic peptide Indication: Plaque psoriasis (also in trials for psoriatic arthritis and ulcerative colitis) FDA Submission: July 2025 Expected Decision: 2026
Icotrokinra would be the first approved oral peptide designed to block the IL-23 receptor. It targets the autoimmune pathway that drives psoriasis, competing with injectable biologics (like ustekinumab and guselkumab) and oral small molecules (like deucravacitinib and apremilast).
What to watch: Approval would validate oral peptide delivery for autoimmune disease — a therapeutic area where peptides have had limited success until now. If efficacy matches injectable biologics, the convenience of a pill could shift treatment patterns significantly.
4. Wegovy for Heart Failure with Preserved Ejection Fraction (Novo Nordisk)
Type: GLP-1 receptor agonist peptide (new indication) Indication: Heart failure with preserved ejection fraction (HFpEF) in adults with obesity Expected Decision: 2026
Novo Nordisk filed for this new indication based on the STEP-HFpEF trial, which showed Wegovy improved symptoms and physical function in obese adults with HFpEF. Approval would expand semaglutide's addressable market into cardiology.
What to watch: HFpEF has been historically difficult to treat. An effective obesity-linked treatment could open a significant new patient population for GLP-1 therapy.
Phase 3 Candidates Approaching FDA Submission
These drugs are in late-stage Phase 3 trials with FDA submissions expected in 2026-2027.
5. CagriSema (Novo Nordisk)
Type: Combination peptide — semaglutide 2.4 mg + cagrilintide 2.4 mg (long-acting amylin analogue) Indication: Obesity and type 2 diabetes Stage: FDA submission expected early 2026 Projected Launch: 2027
CagriSema is Novo Nordisk's answer to tirzepatide's efficacy advantage. In the Phase 3 REDEFINE 1 trial, CagriSema demonstrated 22.7% mean weight loss at 68 weeks — matching what tirzepatide achieved in SURMOUNT-1. The combination also showed superior HbA1c reduction versus semaglutide alone (1.91 vs. 1.76 percentage points) and weight loss of 14.2% in diabetes patients.
What to watch: Timing of the FDA filing and the decision. If CagriSema reaches market in 2027, it gives Novo a competitive product against Zepbound. The complexity of a two-molecule combination may create manufacturing and pricing challenges.
6. Retatrutide (Eli Lilly)
Type: Triple agonist peptide (GIP/GLP-1/glucagon receptor) Indication: Obesity, type 2 diabetes, knee osteoarthritis, obstructive sleep apnea, MASLD, cardiovascular outcomes Stage: Multiple Phase 3 trials; seven readouts expected in 2026 Projected Approval: 2027-2028
Retatrutide is the most potent anti-obesity drug candidate in clinical development. In the Phase 3 TRIUMPH-4 trial (knee osteoarthritis), retatrutide achieved up to 28.7% weight loss and significant improvements in pain and physical function at 68 weeks. It is the first candidate to incorporate glucagon receptor agonism alongside GIP and GLP-1 activity, which may provide additional benefits for liver fat reduction and metabolic health.
Lilly has seven additional Phase 3 readouts expected in 2026, testing multiple dose levels (4 mg, 9 mg, 12 mg) across several indications.
What to watch: The breadth of Phase 3 data will determine whether retatrutide is approved for obesity alone or for multiple indications simultaneously. GlobalData predicts a 2027 approval with $15.6 billion in projected 2031 sales. Manufacturing scale-up for a triple agonist peptide will be a significant undertaking.
7. Survodutide (Boehringer Ingelheim)
Type: GLP-1/glucagon receptor dual agonist peptide Indication: Obesity, type 2 diabetes, cardiovascular disease Stage: Multiple Phase 3 SYNCHRONIZE trials underway Projected Submission: 2027
Survodutide achieved nearly 19% weight loss in Phase 2, and it is now in Phase 3 across three major trials: SYNCHRONIZE-1 (obesity without diabetes), SYNCHRONIZE-2 (obesity with type 2 diabetes), and SYNCHRONIZE-CVOT (cardiovascular outcomes). The glucagon receptor activation component differentiates survodutide from pure GLP-1 agonists and may confer additional liver fat reduction benefits.
What to watch: Phase 3 efficacy data. If survodutide confirms its Phase 2 results at scale, Boehringer will have a competitive obesity drug with a differentiated mechanism. The cardiovascular outcomes trial will take longer but could unlock the cardiology market.
8. Amycretin — Subcutaneous and Oral (Novo Nordisk)
Type: Unimolecular GLP-1/amylin receptor dual agonist peptide Indication: Obesity and overweight Stage: Phase 3 program launching early 2026 Projected Submission: 2028-2029
Amycretin combines GLP-1 and amylin receptor activity in a single molecule. In a Phase 1b/2a trial, the highest subcutaneous dose (20 mg) produced 22% average weight loss over just 36 weeks — with no plateau, suggesting greater losses were possible with continued treatment. Lower doses produced 16.2% (5 mg) and 9.7% (1.25 mg) weight loss.
Novo is developing both subcutaneous and oral versions of amycretin. If Phase 3 confirms the Phase 2 data, amycretin could be Novo's most potent obesity product — potentially exceeding CagriSema's efficacy in a simpler, single-molecule format.
What to watch: Phase 3 enrollment and timeline. GlobalData anticipates U.S. approval in Q4 2030 if trials succeed. The oral version of amycretin could be particularly transformative for market access.
Emerging Phase 2/3 Candidates (2027-2028 Window)
9. MariTide / Maridebart Cafraglutide (Amgen)
Type: Long-acting peptide-antibody conjugate (GLP-1 agonist + GIP antagonist) Indication: Obesity Stage: Phase 3 MARITIME program actively enrolling Projected Submission: 2027-2028
MariTide achieved up to 20% weight loss at 52 weeks in Phase 2 with once-monthly dosing — no plateau was observed, indicating further weight loss potential with longer treatment. Its 21-day half-life enables monthly (or potentially less frequent) injection, a significant convenience advantage over weekly GLP-1 drugs.
The MARITIME Phase 3 program includes studies in chronic weight management, cardiovascular disease, heart failure, and obstructive sleep apnea.
What to watch: Whether once-monthly dosing maintains its efficacy advantage at scale. Amgen is also testing dose reduction and weight maintenance strategies, which could differentiate MariTide for long-term treatment.
10. Pemvidutide (Altimmune)
Type: GLP-1/glucagon receptor dual agonist peptide Indication: NASH/MASLD, obesity, alcohol use disorder Stage: Phase 3 Projected Submission: 2027-2028
Pemvidutide targets the NASH/MASLD market — a massive unmet need with an estimated 115 million affected adults globally. The GLP-1/glucagon dual mechanism may be particularly suited to liver disease, as glucagon receptor activation promotes hepatic fat oxidation.
What to watch: NASH/MASLD trial readouts. The NASH market has been notoriously difficult for drug developers, with multiple late-stage candidates failing. If pemvidutide succeeds, Altimmune would be valued dramatically higher.
11. Balixafortide (Polyphor/Spexis)
Type: 15-amino-acid cyclic peptide (CXCR4 antagonist) Indication: Hematopoietic stem cell mobilization Stage: Phase 3 (NCT03786094)
Balixafortide targets the CXCR4 chemokine receptor, which plays a role in stem cell retention in bone marrow. The drug is being studied for stem cell mobilization in transplant patients. Its cyclic structure gives it improved stability and specificity compared to linear peptide CXCR4 antagonists.
12. Ecnoglutide
Type: GLP-1 receptor agonist peptide Indication: Type 2 diabetes (with potential for obesity) Stage: Phase 2 completed; Phase 3 planning
Ecnoglutide published Phase 2 results in Nature Communications showing efficacy and safety in adults with type 2 diabetes. It represents another entrant in the increasingly crowded GLP-1 agonist space.
Therapeutic Areas to Watch
Obesity and Metabolic Disease
The obesity pipeline is the most crowded and commercially significant. At least eight peptide-based obesity drugs are in Phase 2 or later:
| Drug | Developer | Mechanism | Max Weight Loss | Stage |
|---|---|---|---|---|
| Retatrutide | Eli Lilly | Triple GIP/GLP-1/glucagon | 28.7% | Phase 3 |
| CagriSema | Novo Nordisk | Semaglutide + amylin | 22.7% | Filing 2026 |
| Amycretin | Novo Nordisk | GLP-1/amylin dual | 22% | Phase 3 (2026) |
| MariTide | Amgen | GLP-1 agonist/GIP antagonist | 20% | Phase 3 |
| Survodutide | Boehringer | GLP-1/glucagon dual | 19% | Phase 3 |
| Semaglutide 7.2 mg | Novo Nordisk | GLP-1 agonist | TBD | FDA review |
| Oral semaglutide 50 mg | Novo Nordisk | GLP-1 agonist | TBD | Phase 3 |
| Pemvidutide | Altimmune | GLP-1/glucagon dual | TBD | Phase 3 |
The escalation from 15% weight loss (semaglutide 2.4 mg) to nearly 29% (retatrutide) in just a few years is remarkable. By 2028, patients and physicians will have multiple options, each with different mechanisms, dosing schedules, and side effect profiles.
Autoimmune Disease
Icotrokinra (J&J) could open a new frontier for oral peptide therapy in psoriasis, psoriatic arthritis, and ulcerative colitis. If successful, it would prove that peptides can compete with monoclonal antibodies in autoimmune disease — at a fraction of the manufacturing complexity.
Oncology
Peptide-drug conjugates (PDCs) are emerging as an alternative to antibody-drug conjugates (ADCs), offering tumor-targeting capability with smaller, more penetrating molecules. Peptide-receptor radionuclide therapy (like Novartis's Lutathera for neuroendocrine tumors) has established a proof of concept.
The cyclic peptide drug market is growing at a 21.4% CAGR, and 66 cyclic peptide drugs have been approved globally. Many of the newest candidates target oncology.
Liver Disease (NASH/MASLD)
Wegovy is now approved in the U.S. for MASH, and the EMA adopted a positive opinion for semaglutide 2.4 mg for MASH treatment. This opens a massive new market for GLP-1 peptides. Survodutide and pemvidutide are also targeting this space with dual agonist mechanisms that may offer additional liver-specific benefits.
Cardiovascular Disease
The SELECT trial established that GLP-1 agonists reduce cardiovascular risk. Multiple pipeline candidates (retatrutide, survodutide, MariTide) include cardiovascular outcomes trials in their Phase 3 programs. An FDA approval for cardiovascular risk reduction would significantly expand the prescriber base beyond endocrinologists and obesity specialists into cardiology.
Key Clinical Trials to Follow in 2026
| Trial | Drug | Developer | Indication | Expected Milestone |
|---|---|---|---|---|
| TRIUMPH trials (7 readouts) | Retatrutide | Eli Lilly | Obesity, T2D, OA, OSA, MASLD, CV | Phase 3 data throughout 2026 |
| REDEFINE program | CagriSema | Novo Nordisk | Obesity, T2D | FDA filing expected early 2026 |
| SYNCHRONIZE-1, -2, -CVOT | Survodutide | Boehringer | Obesity, T2D, CV | Phase 3 readouts 2026-2027 |
| MARITIME program | MariTide | Amgen | Obesity, CV, HF, OSA | Phase 3 enrollment/interim 2026 |
| ATTAIN (FDA review) | Orforglipron | Eli Lilly | Obesity, T2D | FDA decision mid-2026 |
| Amycretin Phase 3 | Amycretin | Novo Nordisk | Obesity | Phase 3 enrollment begins 2026 |
| OASIS (high-dose) | Semaglutide 7.2 mg | Novo Nordisk | Obesity | FDA decision Q1 2026 |
The Regulatory Environment
FDA Guidance on Peptide Drug Products
The FDA has issued updated clinical pharmacology considerations for peptide drug products, reflecting the growing complexity and diversity of peptide therapeutics. Key areas of regulatory focus include:
- Immunogenicity assessment: Peptide drugs can trigger antibody formation; the FDA now requires more comprehensive immunogenicity testing.
- Bioequivalence standards for peptide generics: With semaglutide patents expiring internationally, regulators are establishing frameworks for peptide biosimilars and generics.
- Oral peptide bioavailability: New guidance addresses the unique pharmacokinetic challenges of oral peptide delivery.
Compounding Restrictions
The FDA has tightened rules on peptide compounding. Starting in January 2025, revised policies on bulk drug substances limited compounding pharmacies' ability to produce peptides like semaglutide and tirzepatide. The move is expected to phase out smaller, non-compliant compounders and redirect patients toward FDA-approved products. Legal battles between compounding pharmacies and the FDA are ongoing.
Accelerated Approval Pathways
Several peptide candidates are leveraging accelerated pathways:
- The CMPV (Community Medicines Pathway for Verification) pilot program was used for the high-dose semaglutide 7.2 mg submission.
- Orphan drug designations (which accounted for half of 2025 FDA approvals) are available for peptide candidates targeting rare diseases.
- Breakthrough therapy designations can speed review for peptide drugs demonstrating substantial improvement over existing treatments.
FAQ
How many peptide drugs are currently approved by the FDA?
Approximately 102 peptide-based drugs have received FDA approval, including insulin analogs, GLP-1 agonists, somatostatin analogs, and various specialty peptides. Among these, only 11 are administered orally — the rest require injection.
What is the most anticipated peptide drug approval in 2026?
Orforglipron (Eli Lilly) and high-dose semaglutide 7.2 mg (Novo Nordisk) are the most anticipated. Orforglipron would be the second oral GLP-1 for obesity and the first small-molecule oral GLP-1. The 7.2 mg semaglutide could improve weight loss results for the world's most prescribed GLP-1 drug.
When will retatrutide be available?
Retatrutide has seven Phase 3 readouts expected in 2026. If results are positive, Eli Lilly is expected to submit to the FDA in late 2026 or 2027, with potential approval in 2027-2028. GlobalData projects 2031 sales of $15.6 billion.
What peptide drugs could be approved for conditions beyond obesity?
Several pipeline candidates target non-obesity indications:
- Icotrokinra (psoriasis, psoriatic arthritis, ulcerative colitis)
- Retatrutide (knee osteoarthritis, obstructive sleep apnea, MASLD)
- Pemvidutide (NASH/MASLD, alcohol use disorder)
- Balixafortide (hematopoietic stem cell mobilization)
- Semaglutide new indications (heart failure, MASH, potentially Alzheimer's and addiction)
How does the FDA regulate peptide generics?
Peptide generics (sometimes called "follow-on peptides") face a more complex regulatory pathway than small-molecule generics. The FDA requires demonstration of pharmaceutical equivalence and sometimes clinical data, depending on the complexity of the peptide. Manufacturing consistency is a particular focus, as peptide production via SPPS is technically demanding.
What does the compounding ban mean for peptide access?
The FDA's restriction on peptide compounding means that compounding pharmacies can no longer produce copies of FDA-approved peptide drugs (like semaglutide) once the drug is no longer on the shortage list. This funnels patients toward branded products, which are more expensive but also held to higher manufacturing and quality standards.
The Bottom Line
The peptide drug pipeline for 2026-2028 is the richest it has ever been. At least four peptide-related drugs are under FDA review right now, with decisions expected in 2026. Behind them, a wave of Phase 3 candidates — retatrutide, CagriSema, survodutide, amycretin, MariTide — are generating clinical data that could reshape treatment for obesity, diabetes, liver disease, and cardiovascular conditions.
The central theme is escalation. Weight loss efficacy has gone from 15% (semaglutide 2.4 mg) to nearly 29% (retatrutide) in Phase 3. Dosing frequency has gone from daily to weekly to monthly (MariTide). Administration route has shifted from injection-only to pills. And indications have expanded from diabetes alone to obesity, cardiovascular disease, liver disease, sleep apnea, osteoarthritis, and beyond.
For patients, this means more options are coming — and they are coming fast. For the pharmaceutical industry, the 2026-2028 window will determine which companies own the next decade of metabolic medicine. The clinical data from trials reading out this year will write that story.
References
- GoodRx. "Upcoming FDA Approvals: New Drugs and Therapies That May Be Approved in 2026." goodrx.com, 2026.
- Drugs.com. "New FDA Drug Approvals for 2026." drugs.com, 2026.
- Prime Therapeutics. "Quarterly Drug Pipeline: January 2026." primetherapeutics.com, January 2026.
- PharmaLive. "2026 Pipelines to Watch." pharmalive.com, 2026.
- Eli Lilly. "Lilly's Triple Agonist Retatrutide Delivered Weight Loss of Up to 28.7% in Phase 3." investor.lilly.com, 2025.
- Xtalks. "Novo Nordisk's Amycretin Moves to Phase III." xtalks.com, 2025.
- Clinical Trials Arena. "Novo Nordisk Ramps Up Obesity Fight, Advances Amycretin to Phase III." clinicaltrialsarena.com, 2025.
- Amgen. "Phase 2 Obesity Study of Monthly MariTide Presented at ADA 85th Scientific Sessions." amgen.com, June 2025.
- New England Journal of Medicine. "Once-Monthly Maridebart Cafraglutide for the Treatment of Obesity — A Phase 2 Trial." nejm.org, 2025.
- PubMed Central. "2024 FDA TIDES (Peptides and Oligonucleotides) Harvest." pmc.ncbi.nlm.nih.gov, 2024.
- FDA. "Clinical Pharmacology Considerations for Peptide Drug Products." fda.gov, 2024.
- Nature. "Advance in Peptide-Based Drug Development: Delivery Platforms, Therapeutics and Vaccines." nature.com, 2024.