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Ascletis Announces Co-formulation of ASC36, Once-Monthly Next-Generation Amylin Receptor Agonist and ASC35, Once-Monthly Next-Generation GLP-1R/GIPR Dual Agonist for Clinical Development

Ascletis’ co-formulation showed 51% greater weight loss in preclinical studies versus comparators and aims for FDA IND filing in Q2 2026 for obesity treatment.

  • On Nov. 12, 2025, Ascletis Pharma Inc. announced co-formulation of ASC36 and ASC35 for clinical development, showing no aggregation or fibrillation at neutral pH and enabling once-monthly dosing.
  • Using its AISBDD and ULAP platforms, Ascletis Pharma Inc. discovered and developed ASC36 and ASC35 in-house, designing once-monthly subcutaneous ultra-long-acting peptides.
  • Head-to-Head preclinical studies found ASC35 showed 71% greater body weight reduction versus tirzepatide, ASC36 showed 32% greater reduction versus eloralintide, and their co-formulation showed 51% greater reduction versus eloralintide plus tirzepatide with comparable NHP pharmacokinetics.
  • Ascletis expects to submit an IND to the U.S. Food and Drug Administration in the second quarter of 2026 and will host a conference call in Mandarin at 10:00 a.m. China Standard Time on Nov. 13, 2025.
  • Ascletis positions ASC36 as a cornerstone once-monthly therapy, potentially paired with ASC47 in future co-formulations.
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Ascletis Announces Co-formulation of ASC36, Once-Monthly Next-Generation Amylin Receptor Agonist and ASC35, Once-Monthly Next-Generation GLP-1R/GIPR Dual Agonist for Clinical Development

Using Ascletis' proprietary Ultra-Long-Acting Platform technology, co-formulation of ASC36, a once-monthly subcutaneously administered amylin receptor peptide agonist and ASC35, a once-monthly subcutaneously administered GLP-1R/GIPR dual peptide agonist, demonstrated a comparable pharmacokinetic (PK) profile to ASC36 and ASC35 dosed alone…

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PR Newswire broke the news in United States on Wednesday, November 12, 2025.
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