GLP-1s & incretins · Metabolic & endocrine
ASC36
An investigational long-acting amylin receptor peptide agonist in Phase 1 studies for obesity, with no efficacy results in people.
- How settled this rating is:
- very-low confidence in the current evidence rating
- Routes studied:
- Subcutaneous injection, Oral
- Also known as:
- long-acting amylin receptor peptide agonist
- Last reviewed:
- 2026-09-20
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Evidence passport
ASC36
A one-screen evidence identity for this compound. These fields describe research maturity, confidence and legal status. They are not a safety guarantee, efficacy percentage or recommendation.
- Evidence level
- L1Theory only
- Confidence
- Very low confidence in rating
- Regulatory status
- In clinical trials
- Development status
- In clinical development
Evidence strength
Higher = more and better-quality human evidence. It does not mean the effect is bigger or that the compound works for you.
Higher = more mature, better-documented human safety data. It does not mean the compound is safer than one with a lower number.
The 0-100 values rate the strength and maturity of evidence, not how effective or safe the compound is.
- Evidence base
- Includes human studies
- Furthest established stage
- Phase I
- Human research maturity
- Phase 1 studies initiated in the US during 2026 (injection August 2026, oral tablet September 2026), sponsor-reported; no efficacy results in people
- Source curation
- Sources fully curated
Routes recorded
Overview
Higher = more and better-quality human evidence. It does not mean the effect is bigger or that the compound works for you.
Higher = more animal, tissue or cell research. Preclinical results are a starting point, not proof of a human benefit.
Higher = more mature, better-documented human safety data. It does not mean the compound is safer than one with a lower number.
How to read these scores
Every number here rates the evidence, not the compound. They are editorial 0-100 strength ratings, not percentages, and not a rating out of five stars.
- Human efficacy evidence strength — Higher = more and better-quality human evidence. It does not mean the effect is bigger or that the compound works for you.
- Preclinical evidence strength — Higher = more animal, tissue or cell research. Preclinical results are a starting point, not proof of a human benefit.
- Human safety evidence strength — Higher = more mature, better-documented human safety data. It does not mean the compound is safer than one with a lower number. A score of 80 does not mean “80% safe”.
- Evidence level (L0-L5) — the strongest type of study behind the compound, from anecdote (L0) to large replicated human trials (L5). It is a description of the study evidence, not a quality, safety or recommendation rating.
- Confidence — how likely we think it is that this rating changes as new research lands. Low confidence means the picture is unsettled, not that the compound is bad.
None of these ratings is medical advice, a safety guarantee, or a recommendation to use anything. How we grade evidence.
How far human research has progressed: Phase 1 studies initiated in the US during 2026 (injection August 2026, oral tablet September 2026), sponsor-reported; no efficacy results in people
Routes & formulations
Studied / approved routes
The sponsor reports both a long-acting injection and a separate oral tablet programme entering Phase 1. Formulations are studied separately and results do not transfer between them.
Route availability is not evidence of efficacy, and evidence from one route does not transfer to another. The Registry never provides dosing or sourcing information.
Peptide lifecycle
Discovery
Preclinical
Phase I
Furthest established stage
Phase II
Phase III
Approved
Last documented development: September 2026 — Phase 1 initiation of the oral tablet programme
What it is
A peptide agonist of the amylin receptor designed for very long dosing intervals, developed by Ascletis. Amylin-pathway drugs act on satiety signalling rather than the incretin pathway.
What people claim
- Monthly or quarterly weight-loss injection
- Better weight loss than other amylin drugs
What the evidence actually says
What people claim: that this outperforms other amylin analogues and offers monthly or quarterly dosing. What the evidence actually says: the comparisons reported by the sponsor are relative body-weight reductions in diet-induced obese rats. Rodent comparisons do not establish human weight loss, and the human programme is at Phase 1 safety stage.
Related evidence
Useful next reads based on this compound — not recommendations.
- Related compound
Tirzepatide evidence profile
A dual GIP and GLP-1 receptor agonist with strong Phase 3 weight and glycaemic data.
- Compare
Compare ASC36 vs Tirzepatide evidence
Same questions, same fields, side by side — including how much human evidence exists.
- Checked claim
Claim review: “Tirzepatide improves obstructive sleep apnoea in people with obesity.”
A closely related claim we have graded, from GLP-1s.
- Context
GLP-1 Centre
How the incretin medicines compare on trial evidence and where they are actually licensed.
Human evidence
- Phase 1 study of the long-acting injection initiated in the US in August 2026 following IND clearance, sponsor-reported.
- A separate Phase 1 study of an oral tablet formulation was reported as initiated in September 2026.
- No human efficacy results. Phase 1 studies here evaluate safety, tolerability and pharmacokinetics.
Preclinical evidence
- Sponsor-reported head-to-head diet-induced obese rat studies described greater relative body-weight reduction for ASC36 than for petrelintide and eloralintide. These are animal comparisons reported by the sponsor, not peer-reviewed human comparisons.
- Sponsor-reported non-human primate work described oral bioavailability of about 6–8% at steady state and mean body-weight reduction of up to 13.2% from baseline after seven days of once-daily oral dosing.
Animal and cell findings are Level 1–2 evidence.
Mechanism and pathways
Receptor targets: Amylin receptor
Mechanism class counts the receptors the pharmacology engages and says whether one molecule or several drugs do it. More targets is not the same as more effective, and none of these labels is a receptor name — there is no GLP-3, GLP-4 or GLP-5 receptor.
- Amylin receptor agonism promotes satiety and slows gastric emptying.
- This is a non-incretin pathway, so GLP-1 and GIP trial results do not transfer to it.
- Long duration comes from the molecule's design, which also means any adverse effect persists for longer between doses.
Safety and unknowns
- No human safety profile is established; Phase 1 studies are evaluating safety and tolerability.
- Nausea and other gastrointestinal effects are recognised class considerations for amylin-pathway drugs.
Cancer relevance
This section covers questions raised by how the compound works in the body, plus anything regulators and trial teams keep an eye on. It is not a statement that this compound causes cancer — for most compounds here, no human data exist in either direction.
No established human signal
Regulatory status
Regulatory decisions apply to specific jurisdictions, products, formulations and indications. An approval elsewhere is not automatically an approval in your country.
Check the regulatory note and linked primary sources for jurisdiction-specific details.
Not approved anywhere. The sponsor reports US investigational new drug clearance and initiated Phase 1 studies in 2026. IND clearance permits human testing; it is not approval and not evidence of benefit.
Evidence grade
Mechanistic rationale or early development without qualifying compound-specific outcome evidence. A registered trial is not a result.
What would change our rating?
- Posted or peer-reviewed Phase 1 safety and pharmacokinetic results.
- A registered Phase 2 trial with weight endpoints.
- Independent, peer-reviewed publication of the preclinical comparisons.
References and sources
Source transparency
A provenance snapshot of this profile. Counts show what kinds of sources are cited, not how much scientific weight each source deserves.
- Last editorial review
- 2026-09-20
- Recently reviewed · 26 days ago
- Linked curated sources
- 2
- Sources still pending
- 0
- External specialist reviews
- 0
- None recorded for this profile
Review provenance
Registry editorial review: Colin Jackson-White, creator and editor, who is not a doctor or clinician. External specialist review is credited only when a named reviewer has completed a review of this exact profile.
Current linked evidence is sponsor-only. Treat findings as provisional until independent or peer-reviewed documentation is available.
Literature-discovery and AI tools may help locate or challenge candidate evidence, but they are not counted as evidence sources here. Registry judgements are tied to the underlying papers, trial records, regulator documents and official study records.
- Sponsor / officialAscletis — initiation of two US Phase 1 studies in obesity: ASC36 once-monthly injection and ASC36_35FDC (10 August 2026)
- Sponsor / officialAscletis / HKEXnews — initiation of US Phase 1 study of oral amylin receptor peptide agonist ASC36 (8 September 2026)
Source hierarchy: regulatory documents and trial registries first, peer-reviewed work next, sponsor material flagged as non-independent. We never use supplier or clinic marketing as evidence, and where a verified source has not yet been curated we say so rather than inventing one.
Evidence change history
These entries record changes to our assessment of the published evidence — not changes to the compound itself.
No recorded changes yet. Baseline position set on 2026-09-20.