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ASC36: What Ascletis’ Phase 1 Amylin Agonist Trial Is Testing

Update — October 26, 2026

On October 21, 2026, Ascletis reported preclinical pharmacokinetic data for its oral amylin-pathway program. In non-human primates, the company reported an ASC36 half-life of up to about 167 hours and oral bioavailability of roughly 6 to 8 percent. These are animal measurements; no human data have been published, and the U.S. Phase 1 study described below is still the first human testing. Ascletis also said it expects to submit FDA IND applications in the fourth quarter of 2026 for related combination and sibling candidates (ASC35, ASC37 and fixed-dose combinations with ASC36), and that topline human pharmacokinetic data for ASC36 are expected by the end of 2026. These are company statements, not peer-reviewed results.

Evidence & Research Status

Evidence LevelEarly Human Testing — No Results Published
FDA StatusNot FDA-approved for human use
Regulatory StatusResearch Use Only (RUO) — not for human consumption
Last UpdatedSeptember 11, 2026
What This Article Covers

ASC36 is the newest amylin receptor agonist to enter human testing in the crowded obesity-peptide field. On September 8, 2026, Ascletis Pharma announced the start of a U.S. Phase 1 study of ASC36…

Evidence Level reflects the general state of published research for this compound category and is not a claim about the safety, efficacy, or approval status of any product sold on this site. All compounds are offered strictly for research use.

ASC36 is the newest amylin receptor agonist to enter human testing in the crowded obesity-peptide field. On September 8, 2026, Ascletis Pharma announced the start of a U.S. Phase 1 study of ASC36 oral tablets, joining a short list of amylin-pathway compounds that researchers have been tracking alongside GLP-1 and GIP mechanisms.

What ASC36 Is

ASC36 is an oral amylin receptor peptide agonist that Ascletis Pharma designed using its in-house AI-assisted structure-based drug discovery platform (AISBDD). Amylin is a pancreatic hormone that works alongside insulin to regulate satiety and gastric emptying, and the amylin receptor has become a second major target in obesity research — distinct from, but often studied alongside, the GLP-1 and GIP receptors that tirzepatide and semaglutide act on. ASC36 was engineered specifically for oral bioavailability, using a tablet formulation Ascletis calls its POTENT delivery technology, which the company has also applied to earlier oral peptide programs.

The Phase 1 Trial Ascletis Just Started

The newly initiated U.S. study will enroll 86 participants with obesity or overweight and is designed to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of single and multiple ascending oral doses of ASC36. This is the standard first-in-human structure for a novel peptide: establish a safety margin and a dosing curve before any efficacy claim can be made. Ascletis has also filed a separate IND for ASC36 in combination with its GLP-1R/GIPR agonist ASC35 as a fixed-dose co-formulation, and initiated a parallel Phase 1 study for that combination, signaling the company sees amylin-pathway and incretin-pathway agonism as complementary rather than competing approaches.

What the Preclinical Data Actually Showed

Company-reported preclinical findings, presented at EASO 2026, describe a 32-day average observed half-life in non-human primates — reported as roughly six times longer than petrelintide in the same model — supporting an eventual once-monthly dosing interval. In a diet-induced obesity rat model, researchers observed 91% and 32% more relative weight loss compared with petrelintide and eloralintide, respectively, under the study’s specific dosing conditions. In non-human primates dosed with the oral tablet once daily for seven days, mean body weight fell by up to 13.2% from baseline. These are preclinical, company-generated comparisons — not head-to-head clinical trial data — and none of it has been independently replicated or peer-reviewed in a published journal as of this writing.

How ASC36 Fits Among the Other Amylin-Pathway Compounds

Researchers tracking this space are now watching at least four distinct amylin receptor agonists move through development at different paces, each with a different sponsor, formulation, and public-data footprint:

CompoundSponsorStageRoute
ASC36Ascletis PharmaPhase 1 (started Sept 2026)Oral tablet
Eloralintide (LY3841136)Eli LillyPhase 2 complete, published in The LancetSubcutaneous injection
PetrelintideZealand Pharma / RochePhase 3 (CANYON program)Subcutaneous injection
CagrilintideNovo NordiskApproved in combination (CagriSema)Subcutaneous injection

Cagrilintide is the only compound in this table with a mature, publicly available research-chemical supply chain. Eloralintide and petrelintide are further along clinically but, per this week’s coverage-gap review, are already carried by multiple third-party research-chemical suppliers despite being unapproved investigational drugs. ASC36 is not — see below.

Development Stage and What’s Not Publicly Known

ASC36 is a proprietary Ascletis asset. Unlike some clinical-stage peptides whose sequence becomes public through patent filings and is subsequently listed by chemical suppliers, no published peptide sequence, CAS registry number, or third-party synthesis of ASC36 could be found as of this writing, and no research-chemical vendor lists it for sale. That makes ASC36 categorically different from BPC-157, TB-500, or even eloralintide, all of which have public structures and established research-chemical supply chains regardless of their regulatory status. A molecule with an undisclosed sequence cannot be sourced, synthesized, or verified by a third party — there is nothing to buy.

Open Questions for Researchers

The company’s own preclinical comparisons against petrelintide and eloralintide used different animal models and dosing protocols than the sponsors’ own published data, so a direct efficacy ranking cannot be drawn from a press release. Whether the 32-day non-human-primate half-life translates into a genuinely once-monthly human dosing interval, and whether the oral tablet’s absolute bioavailability (reported at 6-8% in the non-human primate model) is sufficient for a competitive human efficacy profile, are both open questions the Phase 1 data will need to answer. Researchers should also note that ASC36 and its ASC35 co-formulation are being developed in parallel, which may affect how quickly standalone ASC36 data becomes available versus combination data.

Portal to Wellness does not currently stock ASC36 — its structure has not been publicly disclosed, so there is nothing to source. It has been added to our compound watchlist for researchers who want to flag interest as more data becomes public.

All compounds referenced in this article are available for research use only. This article is provided for informational and educational purposes. No therapeutic claims are made or implied.

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