By Fineline Cube 
Ascletis Pharma Inc. (HKG: 1672) announced it has selected ASC37 oral tablets, its first GLP‑1R/GIPR/GCGR triple peptide agonist, as a clinical development candidate and expects to submit an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) for obesity treatment in Q2 2026.
Drug Profile & Preclinical Potency
| Receptor Target | ASC37 vs. Retatrutide Potency | Implication |
|---|---|---|
| GLP‑1R | 5‑fold more potent | Enhanced glycemic control & appetite suppression |
| GIPR | 4‑fold more potent | Improved insulin sensitivity & energy metabolism |
| GCGR | 4‑fold more potent | Increased energy expenditure & fat oxidation |
ASC37 is the first oral triple agonist to emerge from Ascletis’ proprietary Peptide Oral Transport ENhancement Technology (POTENT), designed to overcome oral bioavailability limitations of peptide drugs.
Technology Platforms
- POTENT: Enables oral delivery of large peptide molecules by enhancing intestinal absorption and protecting against enzymatic degradation.
- AISBDD (Artificial Intelligence‑Assisted Structure‑Based Drug Discovery): Accelerated discovery and optimization of ASC37’s peptide sequence, resulting in superior receptor binding affinity and metabolic stability.
- Global IP: Patent filings cover the peptide composition, oral formulation, and therapeutic use in metabolic diseases.
Development Timeline & Regulatory Strategy
| Milestone | Target Date | Scope |
|---|---|---|
| FDA IND Submission | Q2 2026 | Obesity indication, US |
| Phase 1 Initiation | H2 2026 | Safety, PK, PD in healthy volunteers & patients |
| Phase 2a Planning | 2027 | Efficacy signals in obesity; potential expansion to diabetes |
| China Parallel Path | TBD | Domestic IND filing under discussion |
Market Opportunity & Competitive Landscape
- Obesity Market: Global market projected to exceed $130 billion by 2030; oral therapies expected to capture >60 % share due to patient preference.
- Differentiation: ASC37’s oral route and enhanced potency vs. injectable competitors (retatrutide, tirzepatide) could enable once‑daily dosing with superior efficacy.
- First‑Mover Edge: If approved, ASC37 would be among the first oral triple incretin agonists, positioning Ascletis as a leader in next‑generation metabolic therapeutics.
- Analyst Outlook: Momentum from Q2 2026 IND may unlock partnership opportunities with global pharma players seeking oral incretin assets.
Forward‑Looking Statements
This brief contains forward‑looking statements regarding ASC37 development timelines, regulatory submissions, and market potential. Actual results may differ due to clinical, regulatory, and competitive risks.-Fineline Info & Tech