Digestive & weight Long-acting amylin analog
Petrelintide
Regulatory status
Status at a glance
503A compounding status
Not nominated
We found no pending nomination for the 503A bulks list. Unless the substance has another legal pathway (for example, a USP monograph or use in an FDA-approved drug), 503A pharmacies generally may not compound with it.
- FDA approval
- Not FDA-approved for any use
- 503B outsourcing
- Not determined
- Anti-doping (WADA)
- Not on the WADA Prohibited List
- DEA schedule
- Not a controlled substance
About peptide status
Most peptides discussed here are not FDA-approved for any use, and products labeled “research use only” are not for human use. Removal from Category 2 does not authorize compounding. PCAC votes are non-binding recommendations; FDA and HHS make the final decisions.
This is not medical or legal advice, and we do not publish dosing, sourcing or reconstitution information. Talk with a licensed clinician before using any peptide.
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Key takeaway
Petrelintide is an investigational long-acting amylin analog, developed by Zealand Pharma (with Roche) as a once-weekly injection for weight management. In a Phase 2 trial it produced clinically meaningful weight loss over about 42 weeks with gastrointestinal tolerability similar to placebo. As of 2026 it is not approved, with Phase 3 testing planned to begin.
At a glance
- FDA status
- Investigational peptide, not approved by the FDA or any regulator
- What it is
- Long-acting amylin analog given as a once-weekly injection
- Research
- Human evidence is a single positive Phase 2 trial in obesity
- Development
- Phase 3 registration trials planned but not yet completed
- Evidence strength
- Moderate research
Summary
Petrelintide is an investigational long-acting amylin analog studied for weight management. Learn how it works and what the Phase 2 research has shown so far.
What is petrelintide?
Petrelintide is an experimental drug that mimics amylin, the pancreatic hormone that signals fullness. It was engineered by Zealand Pharma under the development code ZP8396 for stability and a long half-life suitable for once-weekly injection. It is being developed in collaboration with Roche, including a planned combination study with a separate incretin drug. It is investigational and not approved for any use.
How does it work?
Petrelintide activates amylin receptors, reproducing the satiety signaling of the natural hormone amylin. This is associated with three effects that together lower food intake:
- Reduced appetite
- Slower gastric emptying
- Suppression of glucagon
Because amylin signaling is a different pathway from the GLP-1 and GIP incretin systems, petrelintide is also being explored in combination with incretin drugs. This describes the proposed mechanism, separate from whether it improves outcomes.
Is it FDA-approved?
Safety note
Status: Investigational peptide, not approved by the FDA or any regulator
Category: In clinical trials · Primary body area: Digestive & weight
No. Petrelintide is investigational and not approved by the FDA or any other regulator. According to the developers, Phase 3 registration trials are planned to begin, with additional Phase 2 data in people with type 2 diabetes expected.
What does the research show?
Editor’s note
Evidence strength: Moderate research
It has a single positive, placebo-controlled Phase 2 trial with meaningful weight loss and good tolerability, but no completed Phase 3.
The current evidence is a single Phase 2 trial. According to PubMed, the ZUPREME-1 trial in people with obesity without diabetes reported mean weight loss at two timepoints:
| Timepoint | Mean weight loss |
|---|---|
| 28 weeks | Roughly 9 to 10% |
| 42 weeks | Continuing to around 11% |
Mild nausea was the main side effect, and overall gastrointestinal tolerability was similar to placebo. This is one positive, placebo-controlled Phase 2 study; Phase 3 trials have not yet been completed, so longer-term efficacy and safety remain to be established.
Sources: the ZUPREME-1 Phase 2 trial (Garvey et al., The Lancet Diabetes & Endocrinology, 2026, DOI: 10.1016/S2213-8587(26)00213-5), indexed on PubMed; and Zealand Pharma development updates. This document is educational, is not medical advice or a health claim, and is not an offer to sell any product.
Registered human trials
0 registered human trials on ClinicalTrials.gov that we reviewed
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