Drugs / prosetin
Trials 1
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 1 | NCT05279755 | Feb 2022 → Jun 2026 overdue | amyotrophic lateral sclerosis | ProJenX | Active not recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 4
| Date | Issuer | Release |
|---|---|---|
| 2026-06-16 | ProJenX | Results ProJenX Announces a Development Update for Prosetin, a First-in-Class, CNS-Penetrant MAP4K Inhibitor projenx.com ↗
Interim data from the multiple ascending dose (MAD) portion of PRO-101, which includes 41 ALS participants across five dose levels, support continued development of prosetin as a potential ALS treatment based on its favorable, consistent safety and tolerability, predictable PK activity, and exposure-related peripheral target engagement. |
| 2024-03-28 | ProJenX | Regulatory ProJenX Announces Removal of Partial Clinical Hold for Prosetin Program by FDA projenx.com ↗
ProJenX, a clinical-stage biotechnology company developing novel, brain-penetrant therapies targeting biologically-defined pathways for the treatment of amyotrophic lateral sclerosis (ALS) and other debilitating brain diseases, today announced that the United States Food and Drug Administration (FDA) has removed a partial clinical hold on Study PRO-101, a hybrid Phase 1 clinical trial evaluating prosetin—a first-in-class MAP4 kinase (MAP4K) inhibitor—in healthy volunteers and participants with ALS. |
| 2024-02-14 | ProJenX | Regulatory ProJenX Receives European Authorization for First Study of Prosetin in People Living with ALS projenx.com ↗
ProJenX, a clinical-stage biotechnology company developing novel, brain-penetrant therapies targeting biologically-defined pathways for the treatment of amyotrophic lateral sclerosis (ALS) and other debilitating brain diseases, today announced that it has received authorization in the European Union (EU) for study PRO-101, a hybrid Phase 1 clinical trial evaluating prosetin—a first-in-class MAP4K inhibitor—in healthy volunteers and participants with ALS. |
| 2023-11-29 | ProJenX | Regulatory ProJenX Receives Health Canada Clinical Trial Application Authorization for First Study of Prosetin in People Living with ALS projenx.com ↗
ProJenX, a clinical-stage biotechnology company developing novel, brain-penetrant therapies targeting biologically-defined pathways for the treatment of amyotrophic lateral sclerosis (ALS) and other debilitating brain diseases, today announced authorization of its clinical trial application (CTA) by Health Canada for study PRO-101, a global, hybrid Phase 1 clinical trial evaluating prosetin—a first-in-class MAP4K inhibitor—in healthy volunteers and participants with ALS. |
All press releases naming this drug 5 releases
Evidence & citations 2 cited values
Every value below carries the sentence it was read from. 1 source stands behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | prosetin | ClinicalTrials.gov intervention name — accepted as the source's own label NCT05279755 ↗ |
| Route | Oral | “Healthy volunteers were administered a single dose of prosetin oral solution at 0.03, 0.06, 0.12, or 0.24 mg/kg.” NCT05279755 ↗ |