On September 8, 2026, Ascletis Pharma Inc. (HKEX: 1672) said it has initiated a U.S. Phase I study of ASC36 oral tablets after FDA Investigational New Drug (IND) clearance. The same-day PR Newswire release and the HKEX voluntary announcement call the product an oral amylin receptor peptide agonist for obesity.
A first-in-human start is an operational milestone. It is not human efficacy and it is not FDA approval. The weight-loss, bioavailability, and half-life figures in those filings are company-reported animal data.
ASC36 is not ASC30. ASC30 is Ascletis's once-daily oral small-molecule GLP-1 receptor agonist, already in global Phase 3. This article covers the oral ASC36 Phase I start. It does not rewrite the ASC30 AURORA record.
What happened on September 8
The protocol, as stated in both filings, will evaluate safety, tolerability, pharmacokinetics, and pharmacodynamics after single and multiple ascending oral doses in 86 participants with obesity (BMI at least 30.0 kg/m²) or overweight (BMI at least 27.0 kg/m²).
Jinzi Jason Wu, Ph.D., founder, chairman, and CEO, called the oral tablet study the company's fourth Phase I peptide study initiated in 2026 and a validation of its Peptide Oral Transport ENhancement Technology (POTENT). That fourth-study count is a company claim.
The HKEX filing closes with the Rule 18A.05 caution: the company cannot guarantee that it will ultimately develop, manufacture, and/or commercialize ASC36 successfully.
A ClinicalTrials.gov search on September 9, 2026, for ASC36, for Ascletis plus ASC36, and for "oral amylin receptor peptide agonist" returned no studies. A broader Ascletis query also returned no ASC36 record. This article does not invent an NCT. The public registry listing was not up on the date of this review.
What ASC36 is
ASC36 is an amylin receptor peptide agonist discovered in-house with Ascletis's Artificial Intelligence-assisted Structure-Based Drug Discovery (AISBDD) platform, per the September 8 filings. The oral tablet uses POTENT. The same peptide is also in development as a once-monthly to once-quarterly subcutaneous injection. That injectable program is a separate August 10, 2026, U.S. Phase I start. It is pipeline context, not this week's hook.
Amylin is a pancreatic beta-cell hormone co-secreted with insulin. Independent reviews describe it as slowing gastric emptying, suppressing glucagon, and promoting meal termination. That is class biology, not an ASC36 human result.
ASC36 is not ASC30. Sharing a ticker is not sharing a molecule or a trial phase. It is not eloralintide (LY3841136) or petrelintide. Those peptides appear only as subcutaneous rat comparators. It is not semaglutide, tirzepatide, or CagriSema. Those have human trial records. Oral ASC36 does not.
A research-vendor vial labeled amylin or "oral GLP-1" is not the investigational tablet. A COA check can test whether a certificate names a real lab. It cannot turn a catalog chemical into the Phase I product.
| Asset | What it is | Cited status |
|---|---|---|
| ASC36 oral tablet | Amylin receptor peptide agonist, once-daily oral (company) | U.S. Phase I started Sept. 8, 2026. No NCT as of Sept. 9. |
| ASC36 subcutaneous injection | Same peptide, once-monthly to once-quarterly (company) | Separate U.S. Phase I, Aug. 10, 2026. Two formulations, 72 participants each. |
| ASC36_35FDC | Monthly FDC of ASC36 plus ASC35 (GLP-1R/GIPR peptide) | Separate U.S. Phase I, Aug. 10, 2026. Two formulations, 88 participants each. |
| ASC30 | Once-daily oral small-molecule GLP-1 receptor agonist | Global Phase 3 AURORA. Different molecule. |
Trial design: 86 participants, oral SAD and MAD
The September 8 filings give a short design. They do not publish a full protocol.
| Item | What the Sept. 8 company and HKEX texts say |
|---|---|
| Status | U.S. Phase I initiated after FDA IND clearance |
| Product | ASC36 oral tablets |
| Endpoints named | Safety, tolerability, pharmacokinetics, pharmacodynamics |
| Dosing scheme | Single and multiple ascending oral doses |
| N | 86 participants |
| Eligibility stated | Obesity, BMI at least 30.0 kg/m², or overweight, BMI at least 27.0 kg/m² |
| Randomization, blinding, placebo | Not stated in the Sept. 8 oral announcement |
| Dose table and duration | Not published |
| NCT | Not listed on ClinicalTrials.gov in the Sept. 9 search used here |
Do not paste the August 10 injectable design onto this study. Those subcutaneous protocols were described as randomized, double-blind, and placebo-controlled, and they added weight-related comorbidities to the overweight arm. The oral announcement does not repeat those clauses.
The milligram figures below are animal exposures. They are not a consumer dosing protocol and not the unpublished human dose ladder.
Company preclinical package (animal data only)
Every number in this section is company-reported preclinical data from the September 8 release and HKEX filing. None of it is a human pharmacokinetic or weight-loss result.
In non-human primates, a 10 mg ASC36 oral tablet per animal, once daily for seven days, reached 8% absolute oral bioavailability and a 116-hour elimination half-life at steady state. A 25 mg oral tablet per animal on the same schedule reached 6% bioavailability and a 167-hour half-life. The company footnote defines absolute oral bioavailability as the share of an oral dose that reaches the bloodstream versus an intravenous dose. The company says the 116-to-167-hour half-life supports once-daily and less frequent oral dosing. That is a reading of animal PK, not a human regimen.
The same NHP package says oral tablets reduced mean body weight by up to 13.2% from baseline after once-daily dosing for seven days, and reduced food intake. "Up to 13.2%" is a company animal maximum after one week.
The diet-induced obese (DIO) rat comparison used subcutaneous ASC36, not the oral tablet. After seven days, the company said SQ ASC36 showed about 32% greater relative body-weight reduction than eloralintide injection and about 91% greater relative reduction than petrelintide injection. Relative rat comparisons are not human percentages and not oral-tablet results.
The company says oral ASC36 is expected to use a lower dose than "a recently FDA approved oral GLP-1R peptide agonist," citing potentially better oral bioavailability and efficacy, plus a manufacturing-scalability claim from weight loss per milligram. The filings do not name that approved peptide. This article does not invent the product.
| Snapshot (company, animal only) | Figure | Limit |
|---|---|---|
| NHP oral F, 10 mg/animal, QD × 7 days | 8% absolute oral bioavailability; t½ 116 h | Steady-state animal PK, not human F |
| NHP oral F, 25 mg/animal, QD × 7 days | 6% absolute oral bioavailability; t½ 167 h | Same limit |
| NHP oral weight | Up to 13.2% mean loss from baseline after 7 days | Company animal maximum |
| NHP oral food intake | Reduced (no percentage in the Sept. 8 texts) | Qualitative animal claim |
| DIO rat, SQ ASC36 vs eloralintide | About 32% greater relative weight reduction | SQ rat head-to-head, not oral, not human |
| DIO rat, SQ ASC36 vs petrelintide | About 91% greater relative weight reduction | Same limit |
| Future oral human dose | "Lower" than an unnamed approved oral GLP-1R peptide (company) | Not a protocol |
Why amylin matters (not an ASC36 result)
The independent human record that makes amylin interesting belongs to other drugs, especially when an amylin analog is combined with a GLP-1 agonist.
Garvey et al., New England Journal of Medicine, 2025 (doi 10.1056/NEJMoa2502081, PMID 40544433) reported REDEFINE 1: Phase 3a, 68 weeks, cagrilintide 2.4 mg plus semaglutide 2.4 mg (CagriSema) in adults with overweight or obesity and no diabetes. The paper randomized 3,417 participants. On the treatment-policy estimand, mean body-weight change at week 68 was −20.4% with the combination versus −3.0% with placebo (estimated difference −17.3 percentage points; 95% CI −18.1 to −16.6; P<0.001). Gastrointestinal adverse events occurred in 79.6% versus 39.9% on placebo, mainly transient and mild to moderate. The trial is NCT05567796.
REDEFINE 1 is a different sponsor, a different pair of weekly injectables, and a completed Phase 3a weight-loss trial. An oral ASC36 monotherapy Phase I start does not inherit a 20.4% human result.
Two 2026 reviews map the class without ASC36 data. Fischer and Borner, Pharmacological Research (PMID 42586227) cover cagrilintide, eloralintide, petrelintide, and NN1213, and note that receptor selectivity and exposure kinetics may shape nausea. Alhazmi and le Roux, Diabetes, Obesity and Metabolism (PMID 42452898) review amylin analogs as of April 30, 2026. Neither paper is an ASC36 efficacy study. See also the ADA 2026 GLP-1 pipeline roundup and the eloralintide explainer.
Pipeline context: injectable ASC36, the FDC, and ASC30
On August 10, 2026, Ascletis said FDA IND clearance had allowed two other U.S. Phase I starts: subcutaneous ASC36 as a once-monthly to once-quarterly amylin peptide, and ASC36_35FDC, a once-monthly fixed-dose combination of ASC36 with ASC35, a GLP-1R/GIPR peptide agonist. The company page and the August 10 HKEX filing describe those studies as randomized, double-blind, and placebo-controlled, in adults with obesity (BMI at least 30.0) or overweight (BMI at least 27.0) plus weight-related comorbidities. ASC36 injection evaluates two formulations, 72 participants each. ASC36_35FDC evaluates two formulations, 88 participants each.
Use that August package only as pipeline context. The September 8 hook is the oral tablet. The ASC30 AURORA article remains the small-molecule oral GLP-1 Phase 3 record.
What this does not mean
- It is not human efficacy. No oral ASC36 Phase I safety, PK, PD, or weight result is in the September 8 record.
- It is not FDA approval. IND clearance lets a first-in-human study begin.
- It is not ASC30. ASC30 is an oral small-molecule GLP-1 in Phase 3. ASC36 is an amylin peptide starting oral Phase I.
- NHP 13.2% is not a human weight-loss result. It is a company animal figure after seven oral days.
- Rat 32% and 91% figures are not oral-tablet results and not human percentages. They are company SQ comparisons versus eloralintide and petrelintide in DIO rats.
- 6% to 8% oral bioavailability is not a human F. Those are NHP steady-state company figures at 10 mg and 25 mg per animal.
- REDEFINE 1's −20.4% is not an ASC36 finding. It is CagriSema at 68 weeks.
- There is no NCT to quote yet. The September 9 ClinicalTrials.gov searches used here were empty for the oral study.
- This is not medical advice, and it is not a consumer dosing protocol.
What to watch next
- An NCT posting for the oral tablet study. Until then, the public design stays at the 86-person SAD/MAD sketch.
- First-in-human safety, tolerability, and PK. Phase I is built for those questions, not obesity efficacy.
- Whether a human oral dose is disclosed. The company expects a lower dose than an unnamed approved oral GLP-1R peptide. It has not published the milligram ladder.
- Gastrointestinal tolerability. REDEFINE 1 reported GI events in 79.6% on CagriSema versus 39.9% on placebo. That is a different product and the class signal to watch.
- How the oral program is described next to the August 10 injectable and FDC studies. Same peptide, different route, different protocols.
- Whether later filings keep the Rule 18A.05 caution.
Live semaglutide and tirzepatide pages are price-and-vendor views of different products. They are not ASC36 storefronts.
FAQs
Is ASC36 the same drug as ASC30?
No. ASC36 is an amylin receptor peptide agonist. ASC30 is a once-daily oral small-molecule GLP-1 receptor agonist already in Phase 3 AURORA.
Does a Phase I start mean oral ASC36 works in people?
No. The September 8 announcement is IND clearance plus study initiation. It is not a human efficacy readout and not FDA approval.
What did the company report in animals?
In NHPs, company figures were 8% and 6% steady-state absolute oral bioavailability at 10 mg and 25 mg per animal (half-lives 116 h and 167 h), and up to 13.2% mean weight reduction after seven once-daily oral days. In DIO rats, subcutaneous ASC36 was said to beat eloralintide and petrelintide on relative weight reduction by about 32% and 91%. Those are animal data.
Is there a ClinicalTrials.gov NCT for the oral Phase I?
Not in the September 9, 2026 searches used for this article. Queries for ASC36, Ascletis plus ASC36, and oral amylin receptor peptide agonist returned no studies.
Can someone buy oral ASC36 or use the animal milligram figures?
No. ASC36 is an investigational peptide. The NHP 10 mg and 25 mg per-animal figures are not a human dose and not a consumer protocol.
Does REDEFINE 1 prove anything about ASC36?
No. REDEFINE 1 tested weekly injectable cagrilintide plus semaglutide. It explains why amylin plus GLP-1 is interesting. It does not give ASC36 a human efficacy number.
This article is for general informational purposes only and is not medical advice. Talk to a licensed clinician about personal medical decisions. ASC36 is an investigational amylin receptor peptide. Nothing here is a dosing protocol, an availability claim, or a recommendation to obtain an unapproved product.
Continue your research
- ASC30 oral GLP-1 Phase 3 AURORA
- What is eloralintide (LY3841136)?
- What the GLP-1 pipeline showed at ADA 2026
- Semaglutide price comparison
- Tirzepatide price comparison
- COA Authenticity Checker
Sources
- Ascletis Pharma Inc. Initiation of U.S. Phase I study of oral amylin receptor peptide agonist ASC36 for obesity. PR Newswire. September 8, 2026
- Ascletis Pharma Inc. Voluntary announcement: initiation of U.S. Phase I study of oral ASC36. HKEX. September 8, 2026
- ClinicalTrials.gov search for ASC36 (no studies returned on September 9, 2026)
- Ascletis Pharma Inc. Initiation of two U.S. Phase I studies: ASC36 once-monthly injection and ASC36_35FDC. August 10, 2026
- Ascletis Pharma Inc. Voluntary announcement: ASC36 injection and ASC36_35FDC Phase I starts. HKEX. August 10, 2026
- Garvey WT, et al. Coadministered cagrilintide and semaglutide in adults with overweight or obesity. N Engl J Med. 2025;393:635-647. doi 10.1056/NEJMoa2502081. PMID 40544433
- ClinicalTrials.gov NCT05567796. REDEFINE 1 (cagrilintide plus semaglutide, not ASC36)
- Fischer SL, Borner T. Beyond GLP-1: amylin-based pharmacotherapy. Pharmacol Res. 2026. PMID 42586227
- Alhazmi A, le Roux CW. Amylin analogs: the next major class of weight loss therapy. Diabetes Obes Metab. 2026. PMID 42452898