Drugs / ASC42
Trials 6
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 14 trials | ||||||
| Phase 1 | NCT05464628 | Aug 2022 | — | Gannex Pharma Co., Ltd. | Completed | No outcome recorded |
| Phase 1 | NCT05118516 | Nov → Dec 2021 | — | Gannex Pharma Co., Ltd. | Completed | No outcome recorded |
| Phase 1 | NCT04965337 | Jul → Aug 2021 | — | Ascletis Pharmaceuticals Co., Ltd. | Completed | No outcome recorded |
| Phase 1 | NCT04679129 | Nov 2020 → May 2021 | — | Gannex Pharma Co., Ltd. | Completed | No outcome recorded |
| Phase 22 trials | ||||||
| Phase 2 | NCT05190523 | Apr 2022 → Mar 2024 | primary biliary cholangitis | Gannex Pharma Co., Ltd. | Completed | No outcome recorded |
| Phase 2 | NCT05107778 | Jan 2022 → Nov 2023 | chronic hepatitis B virus infection | Ascletis Pharmaceuticals Co., Ltd. | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 8
| Date | Issuer | Release |
|---|---|---|
| 2024-04-03 | Ascletis Pharmaceuticals Co., Ltd. | Results Ascletis Announces Strategic Decisions on FXR agonist ASC42 ascletis.com ↗
The results indicated that ASC42 did not show competitiveness to new PBC drug candidates currently in development and registrational stages. |
| 2023-11-06 | Ascletis Pharmaceuticals Co., Ltd. | Results Gannex Published Phase I Data of ASC42, a Novel Farnesoid X Receptor Agonist on the Journal Drugs in R&D ascletis.com ↗
This study shows that ASC42 was in general safe and well tolerated when administered as single doses up to 100 mg and multiple daily doses for 14 days up to 15 mg in healthy subjects. |
| 2023-06-26 | Ascletis Pharmaceuticals Co., Ltd. | Results Ascletis Announces Poster Presentation of Phase II Study of ASC42 FXR Agonist for Functional Cure of Chronic Hepatitis B at EASL CONGRESS 2023 ascletis.com ↗
In total, 122, 119, and 107 adverse events (AEs) were reported in 10 mg ASC42, 15 mg ASC42 and PBO cohorts, respectively, and most AEs (94.3%) were mild (grade 1) or moderate (grade 2) in severity. |
| 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. |
| 2021-11-15 | Ascletis Pharmaceuticals Co., Ltd. | Regulatory Gannex Announces China NMPA Approved Phase II and III Protocols of ASC42, an FXR Agonist, for Treatment of Primary Biliary Cholangitis ascletis.com ↗
With the approval of ASC42 PBC Phase II and III protocols by China NMPA, Gannex is expected to complete the Phase II trial in 100 patients who have an inadequate response to or are unable to tolerate Ursodeoxycholic acid (UDCA). |
| 2020-12-14 | Ascletis Pharmaceuticals Co., Ltd. | Regulatory Gannex Received U.S. FDA Fast Track Designation for Its NASH Drug Candidate ASC42，an FXR Agonist ascletis.com ↗ |
| 2020-10-12 | Ascletis Pharmaceuticals Co., Ltd. | Regulatory Gannex Received U.S. IND Approval for Its NASH Drug Candidate ASC42，an FXR Agonist ascletis.com ↗
We are delighted that the FDA has cleared ASC42 IND for NASH, an increasingly prevalent disease for which there are currently no approved therapies, |
| 2020-09-14 | Ascletis Pharmaceuticals Co., Ltd. | Regulatory Gannex Filed US IND for Its NASH Drug ASC42, an FXR Agonist ascletis.com ↗
Shanghai, China, 14 September 2020 -- Gannex Pharma Co., Ltd., a wholly owned company of Ascletis Pharma Inc. (HKEX:1672) announces today that it has filed investigational new drug application (IND) with US FDA for its non-alcoholic steatohepatitis (NASH) drug candidate ASC42. |
All press releases naming this drug 10 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 | ASC42 | “One dose of oral ASC43F FDC tablet containing ASC41 5mg and ASC42 15mg.” NCT05118516 ↗ |
| Action | Activate | “farnesoid X receptor agonist” PMID 37919483 ↗ Nov 2023 |
| Route | Oral | “Oral tablets” NCT04679129 ↗ |