Drugs / ASC41
Trials 7
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 15 trials | ||||||
| Phase 1 | NCT05118516 | Nov → Dec 2021 | — | Gannex Pharma Co., Ltd. | Completed | No outcome recorded |
| Phase 1 | NCT04845646 | Mar → Jun 2021 | NAFLD1 | Gannex Pharma Co., Ltd. | Completed | No outcome recorded |
| Phase 1 | NCT04692025 | Dec 2020 → Jan 2021 | fatty liver disease, hyperlipidemia | Gannex Pharma Co., Ltd. | Completed | No outcome recorded |
| Phase 1 | NCT04686994 | Dec 2020 → Jan 2021 | fatty liver disease, hyperlipidemia, morbid obesity | Gannex Pharma Co., Ltd. | Completed | No outcome recorded |
| Phase 1 | NCT04527250 | Sep → Dec 2020 | — | Ascletis Pharmaceuticals Co., Ltd. | Completed | No outcome recorded |
| Phase 22 trials | ||||||
| Phase 2 | NCT05118360 | Dec 2023 → Nov 2024 | metabolic dysfunction-associated steatohepatitis | Gannex Pharma Co., Ltd. | Withdrawn | No outcome recorded Stop: Business |
| Phase 2 | NCT05462353 | Sep 2022 → May 2025 overdue | NAFLD1, metabolic dysfunction-associated steatohepatitis | Gannex Pharma Co., Ltd. | Active not recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 4
| Date | Issuer | Release |
|---|---|---|
| 2024-06-11 | Ascletis Pharmaceuticals Co., Ltd. | Results Gannex Announces Poster Presentation Describing Positive Interim 12-Week Results from Ongoing 52-Week Phase II Clinical Trial of Once-Daily ASC41 in Patients with Biopsy-Confirmed MASH at EASL CONGRESS 2024 ascletis.com ↗ |
| 2024-01-02 | Ascletis Pharmaceuticals Co., Ltd. | Results Gannex Announces Positive Interim Results from 52-Week Phase II Clinical Trial of Once-Daily ASC41 Tablet in Patients with Biopsy-Confirmed Non-alcoholic Steatohepatitis ascletis.com ↗
Gannex Pharma Co., Ltd. (“Gannex”), a wholly-owned company of Ascletis Pharma Inc. (HKEX:1672, "Ascletis") announces today positive interim results from the 52-week Phase II clinical trial of thyroid hormone receptor β (THRβ) agonist ASC41 tablet for treatment of patients with biopsy-confirmed non-alcoholic steatohepatitis (NASH). |
| 2023-11-13 | Ascletis Pharmaceuticals Co., Ltd. | Results Ascletis Announces Poster Presentations at AASLD Annual Meeting 2023 Including a Late-Breaking Abstract of Interim Results from Phase IIb Expansion Cohort of ASC22 for Functional Cure of CHB ascletis.com ↗
ASC41 demonstrated significant reductions of lipids. |
| 2022-11-07 | Ascletis Pharmaceuticals Co., Ltd. | Results Ascletis Announces Poster Presentation of Phase I, Single-Dose Study of ASC43F for NASH at AASLD Annual Meeting 2022 ascletis.com ↗
This Phase I study demonstrated that ASC43F showed good tolerability and safety profiles, and pharmacokinetics (PK) parameters of ASC41/ASC41A and ASC42 from ASC43F were similar to those of ASC41 and ASC42 as monotherapy. |
All press releases naming this drug 6 releases
Evidence & citations 3 cited values
Every value below carries the sentence it was read from. 7 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | ASC41 | “The primary objective of this study is to evaluate the safety, tolerability and compare the pharmacokinetic parameters of ASC41, a THR beta agonist tables in overweight and...” NCT04686994 ↗7“One dose of oral ASC43F FDC tablet containing ASC41 5mg and ASC42 15mg.” NCT05118516 ↗ |
| Action | Activate | “ASC41, a THR beta agonist” NCT04686994 ↗ |
| Route | Oral | “ASC41 one tablet (1mg) single oral dose at Day 1 and once daily for 14 days from Day 14 to Day 27.” NCT04527250 ↗ |