Drugs / AL01211
Trials 2
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial | ||||||
| Phase 1 | NCT04908462 | Jun 2021 → Jun 2022 | autosomal dominant polycystic kidney disease | AceLink Therapeutics, Inc. | Completed | No outcome recorded |
| Phase 21 trial | ||||||
| Phase 2 | NCT06114329 | Oct 2023 → Dec 2024 | Fabry disease | AceLink Therapeutics, Inc. | Unknown | No outcome recorded |
News releases announcing trial results or a regulatory action · 8
| Date | Issuer | Release |
|---|---|---|
| 2025-08-14 | AceLink Therapeutics, Inc. | Results AceLink Therapeutics Completes 6-Month Primary Phase of AL01211 Clinical Study in Fabry Disease Patients acelinktherapeutics.com ↗ |
| 2025-02-07 | AceLink Therapeutics, Inc. | Results AceLink Therapeutics Presents Interim Results from a Phase 2 Trial of the GCS Inhibitor AL01211 in Treatment-Naïve, Classic Male Fabry Disease Patients at the WORLD Symposium 2025 acelinktherapeutics.com ↗
Interim results indicate that AL01211 is generally safe and well tolerated in classic male Fabry patients. |
| 2024-11-12 | AceLink Therapeutics, Inc. | Regulatory AceLink Therapeutics Announces AL01211 Granted Breakthrough Therapy Status in China for Fabry Disease acelinktherapeutics.com ↗
AceLink Therapeutics, a clinical-stage drug development company, announced today that AL01211, the company’s innovative oral, small molecule drug that is being developed for Fabry disease, was granted “Breakthrough Therapy designation” by the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA). |
| 2024-02-26 | AceLink Therapeutics, Inc. | Results AceLink Therapeutics Announces Publication of Phase 1 Clinical Trial Data Evaluating AL01211 in Healthy Volunteers acelinktherapeutics.com ↗ |
| 2023-08-10 | AceLink Therapeutics, Inc. | Regulatory AceLink Therapeutics Receives FDA Clearance to Initiate a Phase 2 Study of AL1211 in Patients with Fabry Disease acelinktherapeutics.com ↗ |
| 2022-09-07 | AceLink Therapeutics, Inc. | Regulatory AceLink Therapeutics Receives Orphan Drug Designation for its Novel GCS inhibitor AL01211 for the Treatment of Fabry Disease acelinktherapeutics.com ↗
AceLink Therapeutics, Inc. (AceLink), an innovative biopharmaceutical company developing transformative therapies for genetic diseases, today announced it has received Orphan Drug Designation (ODD) from the U.S. Food and Drug Administration (FDA) for AL01211 as a treatment for Fabry Disease. |
| 2022-03-04 | AceLink Therapeutics, Inc. | Regulatory AceLink Therapeutics Received the IND Clearance for AL01211 from Chinese NMPA acelinktherapeutics.com ↗
AceLink Therapeutics Inc., a clinical stage biopharmaceutical company developing transformative therapies for kidney diseases and rare genetic diseases, announced today that the IND application of company’s lead compound AL01211 was approved by Chinese National Medical Products Administration (NMPA) and Center for Drug Evaluation (CDE). |
| 2021-12-10 | AceLink Therapeutics, Inc. | Regulatory AceLink Therapeutics Received the Acceptance of Investigational New Drug Application from Chinese NMPA acelinktherapeutics.com ↗
AceLink Therapeutics Inc., a clinical stage biopharmaceutical company developing transformative therapies for kidney diseases, announced today that the IND application of company’s lead compound AL01211 was accepted by Chinese National Medical Products Administration (NMPA) and Center for Drug Evaluation (CDE). |
All press releases naming this drug 10 releases
Evidence & citations 4 cited values
Every value below carries the sentence it was read from. 3 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | AL01211 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT04908462 ↗ |
| Action | Inhibit | “GCS inhibitor” NCT06114329 ↗ |
| Modality | Small molecule | — CHEMBL6068534 ↗ |
| Route | Oral | “Oral AL01211” NCT04908462 ↗ |