ASC35_Dosage, benefits & legal status
Also known as ASC-35
Fills the gap between ASC36 and ASC37, and shows what a best-in-class claim rests on.
Common vial size is what vendors typically sell, not a recommendation. Enter your own vial in the calculator.
What is ASC35?
Plain language first. The technical label stays, but it never stands alone.Overview
This site already carries ASC36, an amylin agonist, and ASC37, a triple agonist. ASC35 is the one in between: a two-receptor drug meant to be injected monthly rather than weekly. Ascletis calls it potentially best-in-class and backs that up with numbers against tirzepatide, and every one of those numbers comes from monkeys, obese mice or cells in a dish. The first human trial started in August 2026, and what it is set up to measure is side effects, not weight.
ASC35 is an investigational peptide agonist at the GLP-1 and GIP receptors, the same receptor pair as tirzepatide, formulated by Ascletis for subcutaneous injection about once a month. The company attributes the long duration to a formulation it calls SALD, built on its Ultra-Long-Acting Platform and said to release the drug over a period of a month or longer. Its sequence, residue count and receptor potency figures have not been disclosed.
What it's used for
Nothing yet. It is an investigational monthly injection for obesity and overweight, in a phase 1 safety and tolerability trial only.
How does ASC35 work?
What it does in the body, and where.The receptor pair here is not new. Tirzepatide hits GLP-1 and GIP and is approved. What ASC35 is trying to change is not which receptors are hit but how long one injection lasts.
- 01The two receptorsGLP-1 slows the stomach, blunts appetite and improves insulin release. GIP is the second incretin, and pairing the two produces more weight loss than GLP-1 alone. This is the combination tirzepatide already uses, so the mechanism is well established and is not what distinguishes this drug.
- 02The depotAscletis says the monthly formulation, called SALD, comes from its Ultra-Long-Acting Platform and releases the peptide over a month or longer. In monkeys the company reports an average half-life about six times longer than tirzepatide's, with drug exposures roughly 80 percent greater after a vein dose and 70 percent greater under the skin.
- 03Where the best-in-class claim comes fromThree places, none of them human. In cells, Ascletis reports about four times the potency of tirzepatide at both receptors. In diet-induced obese mice, it reports 71 percent greater relative efficacy than tirzepatide. In monkeys, the half-life and exposure figures above. Potency in a dish and weight loss in a mouse have a long history of not carrying over, and the trial now running was not built to settle it.
What else is it used for?
Each group carries its own evidence level.Approved means regulators have cleared it for that purpose. Investigational means it is in trials. Early research means it is being studied and is not established.
Where the numbers come from
Early research- Lab studyAbout four times more potent than tirzepatide at both the GLP-1 and GIP receptors. This is a cell assay, reported by the company that owns the drug.
- Animal studySeventy-one percent greater relative efficacy than tirzepatide in diet-induced obese mice, also company-reported.
- Animal studyIn monkeys, an average observed half-life about six times longer than tirzepatide, with exposures about 80 percent greater by vein and 70 percent greater under the skin. The monthly dosing claim rests on these primate figures.
- No dataNo human efficacy figure exists. Every comparison with tirzepatide above is preclinical, and the company states only that better tolerability may translate to people.
What the human trial will and will not answer
Investigational- Human trialNCT07842640 is recruiting 84 adults with obesity or overweight into four single-dose and four repeat-dose cohorts, started August 27, 2026, with primary completion estimated June 2027.
- Human trialIts primary outcome is adverse events from baseline to day 141. It is a safety, tolerability and pharmacokinetics study, so the first thing it establishes is whether a month-long depot of a dual agonist is tolerable.
- No dataThere is a tirzepatide comparator cohort, and it sits inside that safety study rather than in a weight-loss comparison. A cohort given the approved drug alongside the investigational one is useful for reading the safety and exposure numbers in context, and it is not a test of which produces more weight loss.
The tirzepatide comparisons attached to ASC35 are the thing to watch. Four-fold potency, 71 percent greater efficacy and a six-fold longer half-life are real reported figures, and they come from cells, mice and monkeys respectively, from the company that owns the drug. None of them is a human result, and none of them establishes better weight loss or better tolerability in people. The phase 1 trial does include a tirzepatide cohort, and reading that as a head-to-head weight-loss trial is the second error: its primary outcome is adverse events. The third is ASC36_35FDC, a fixed-dose combination of ASC36 and ASC35 that Ascletis is developing separately. It contains ASC35 and it is not another name for it, so a listing for one is not a listing for the other. ASC35, ASC36 and ASC37 are three different molecules with three different receptor profiles.
The published record
Papers and trials about ASC35
Searched: ASC35, ASC-35.
Left out: GLP-1/GIP dual agonist (a class term whose exemplar is tirzepatide, with a very large literature); Ascletis (a company name covering ASC30, ASC36, ASC37, ASC39 and ASC47, each a different molecule); ASC36_35FDC (the co-formulation, a separate product that contains this molecule; it should not pull into this slug); once-monthly (a dosing descriptor, not a name).
3 papers tagged human · 2 not reviews or lab · 1 clinical trial publications
1 registered trials · none with posted results
Furthest stage reached: Phase 1, under way
Counted from Europe PMC indexing, not read by a person; a human tag can land on reviews, commentary or lab papers; clinical trial publications is the narrower count.
At a glance
Four things to know about ASC35
Evidence
Investigational
Category
Weight loss and metabolic
Common vial
Varies
Half-life
Not established in people
How much, and do you cycle it?
The range, and whether you take breaks.No human dose disclosed; four single-dose and four repeat-dose levels are being tested, about once a month, as formulated. Monthly injection, as formulated No range
The formulation is designed around roughly monthly dosing, and the repeat-dose cohorts of the phase 1 trial are the first test of that interval in people. No schedule has been established.
How long does it stay in the body?
The half-life, and where the figure comes from.Not established in peopleNo figure
No human figure exists. The only half-life data are in non-human primates, where Ascletis reports an average about six times longer than tirzepatide's without giving the number itself. The pharmacokinetics arm of the phase 1 trial is the first measurement in people, and it reads out from 2027.
You can compare this against the whole library to see where it sits.
How do I dose and price it?
Enter your vial and your dose. Pick a mix. We show the draw and the cost.The vial holds a fixed amount of drug. Adding more water does not make more drug, it just spreads it thinner, so you draw a bigger number on the syringe for the same dose.
Choose your mix
Measuring the water1 mL = one full 100-unit syringe.
How do you store it?
Before mixing, and after.Nothing to store: it is not sold anywhere.
ASC35 has never been marketed, so there is no vial, pen or bottle to keep at home. Supplies for a trial are made, stored and dispensed by the sponsor and the trial pharmacy under conditions set in the protocol. Anything offered for sale under this name did not come from that supply chain.
What are the side effects and cautions?
Known cautions and warnings for this compound.Who should avoid it
- Any use outside the trial: no product exists and no human dose has been disclosed
- Anything sold under this name: the sequence has never been published, so a vial cannot be checked against a reference
- Treating it as a tested alternative to tirzepatide: the only head-to-head data are in animals
Stop and get help
- Not applicable outside the trial
Common effects
- Not characterized in people. The first human trial is still recruiting and no results have been posted
- Nausea, vomiting and diarrhea are the usual effects of drugs hitting GLP-1 and GIP, and they have not been measured for this one
Where this page says nothing is established, that means nobody has studied it, not that a compound is safe.
Is ASC35 approved?
And where the numbers on this page come from.No. ASC35 is not approved anywhere and is currently in company-run clinical trials. There is no legal route to obtain it outside a trial.
- Approval statusInvestigational
- RouteUnder the skin (subcutaneous)
- Checked25 October 2026
- DoseNo dose has been established in people.
- Vial sizeFrom what vendors typically list; not a recommendation.
- Sources
What has happened recently
Not approved anywhere. Ascletis announced US FDA clearance of the investigational new drug application on June 23, 2026, describing ASC35 as a potentially best-in-class, once-monthly subcutaneously administered GLP-1 receptor and GIP receptor dual peptide agonist. The trial is NCT07842640, sponsored by Ascletis Pharma (China) Co., Limited, first posted September 25, 2026, started August 27, 2026 and recruiting as of its September 2026 status check: a phase 1, randomized, triple-masked, placebo-controlled single and multiple ascending dose study in 84 adults with obesity or overweight, aged 18 to 65, with primary completion estimated for June 2027. Its primary outcome is adverse events from baseline to day 141. It contains four single-dose cohorts, four repeat-dose cohorts and one active comparator cohort receiving tirzepatide. No FDA substance record, International Nonproprietary Name or CAS number was located.
You can compare this against the whole library, or read how to check a seller.
What else is like ASC35?
Others in GLP-1 agonists, side by side.If you're weighing ASC35, it's worth reading ASC37, Beinaglutide, and Berobenatide in the same class.
Fills the gap between ASC36 and ASC37, and shows what a best-in-class claim rests on.
- Dose
- No human dose disclosed; four single-dose and four repeat-dose levels are being tested
- How often
- About once a month, as formulated
A 41-amino-acid GLP-1, GIP and glucagon peptide with no human data of any kind, and company press releases as its entire evidence base.
- Dose
- No human dose exists
- How often
- Intended once weekly by mouth, or once monthly by injection
China's own GLP-1, and the only one with a fully human sequence.
- Dose
- Set by the Chinese label
- How often
- Three times daily, before meals
An experimental GLP-1 shot built to be given monthly, now in Pfizer's phase 3 program.
- Dose
- 0.4 up to 2.4 mg weekly, or 3.2 to 4.8 mg monthly (trial doses)
- How often
- Weekly, then monthly in some trials
Guides for this compound
- How to Reconstitute a Peptide
Mix peptide powder with bacteriostatic water, step by step.
- How to Read an Insulin Syringe
Read the units, convert to millilitres, and draw the exact dose.
- mcg vs mg: The Peptide Dosing Mistake to Avoid
Your vial says mg and your protocol says mcg. Here is the conversion and how to check it.
- How to Read a Peptide COA
What the purity number does and does not tell you, and how to spot an edited report.
- How to Vet a Peptide Vendor
Independent COAs, HPLC purity, and the red flags that mean walk away.
Sources
- Ascletis Pharma, US FDA IND clearance for the phase 1 study of ASC35, June 23, 2026(2026)The source of every preclinical figure quoted for this compound. Calls ASC35 a potentially best-in-class, once-monthly subcutaneously administered GLP-1R and GIPR dual peptide agonist, developed with the company's Ultra-Long-Acting Platform in a formulation it calls SALD, releasing over a one-month or longer period. Reports, in non-human primates, an average observed half-life about six-fold longer than tirzepatide and intravenous and subcutaneous exposures about 80 percent and 70 percent greater; in diet-induced obese mice, a relative greater efficacy of 71 percent compared to tirzepatide; and in vitro, about four-fold greater potency than tirzepatide at both receptors. States the monkey findings may also translate into better gastrointestinal tolerability in humans. Reports no human data.
- Trade coverage of Ascletis starting the ASC36 and ASC36_35FDC phase 1 studies, August 2026(2026)Cited for the co-formulation point only, and it is trade reporting rather than a primary document. Describes ASC36_35FDC as a once-monthly subcutaneous fixed-dose combination pairing ASC36 with ASC35, aimed at the amylin, GLP-1 and GIP receptors together, using the same SALD depot technology. States that ASC35 received its own FDA investigational new drug clearance and began phase 1 development separately earlier in 2026, and that is what makes the two programs distinct. The ASC36_35FDC study is described as 88 participants per formulation.
- Phase 1 trial record, ClinicalTrials.gov NCT07842640(2026)A phase 1, randomized, double-blind, placebo-controlled single and multiple ascending dose study of ASC35 injection for subcutaneous use in a once-monthly formulation, in adults with obesity or overweight. Sponsor Ascletis Pharma (China) Co., Limited. Recruiting, status verified September 2026, 84 participants estimated, started August 27, 2026, primary completion estimated June 2027, first posted September 25, 2026. Triple masking, sequential assignment. Four single ascending dose cohorts and four multiple ascending dose cohorts receive ASC35 or its placebo, and one further cohort is an active comparator receiving tirzepatide only. The primary outcome is adverse events from baseline to day 141. Ages 18 to 65. The record states no body mass index threshold and does not mention ASC36 or any co-formulation.
Beyond these, 4 records are indexed. Browse the records