Drugs / Darvadstrocel
Darvadstrocel
Regulatory milestones approvals, filings & regulatory actions · 3 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed anal fistula 1 milestone | |||||
| Filed | Japan (PMDA) | — | anal fistula | 2021-02-10 | “today announced that it has submitted an application to the Japanese Ministry of Health, Labour and Welfare to manufacture and market darvadstrocel (development code: Cx601)” takeda.com ↗ |
| Withdrawn Indication not stated 2 milestones | |||||
| Withdrawn | EU (EMA) | Alofisel | — | 2024-12-13 | europa.eu ↗ |
| Approved | EU (EMA) | Alofisel | — | 2018-03-23 | europa.eu ↗ |
Trials 6
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT01372969 | Jun 2009 → Sep 2010 | Crohn disease, anal fistula | Tigenix S.A.U. | Completed | No outcome recorded |
| Phase 34 trials · 1 missed | ||||||
| Phase 3 | NCT04701411 | Jun 2021 → May 2025 | Crohn disease, anal fistula | Takeda | Terminated | No outcome recorded Stop: Business |
| Phase 3 | NCT04075825 | Nov 2019 → Apr 2024 | Crohn disease, anal fistula | Takeda | Completed | No outcome recorded |
| Phase 3 | NCT03706456 | Mar 2019 → Jul 2020 | perianal Crohn disease | Takeda | Completed | No outcome recorded |
| Phase 3 | NCT03279081 | Sep 2017 → Jan 2023 | Crohn disease | Tigenix S.A.U. | Completed | Missed primary |
| Phase 41 trial | ||||||
| Phase 4 | NCT04118088 | Dec 2020 → Feb 2025 | Crohn disease, anal fistula | Takeda | Terminated | No outcome recorded Stop: Business |
News releases announcing trial results or a regulatory action · 6
All press releases naming this drug 6 releases
Evidence & citations 5 cited values
Every value below carries the sentence it was read from. 7 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | darvadstrocel | ClinicalTrials.gov intervention name — accepted as the source's own label NCT04075825 ↗ |
| Known as | Alofisel | ChEMBL registry synonym — accepted as the source's own label CHEMBL4298180 ↗ |
| Known as | CX-601 | “Investigational product: CX-601 Suspension of adult expanded allogenic adipose-derived stem cells (eASCs) at a doses of 20 million cells and 40 million cells.” NCT01372969 ↗ |
| Modality | Cell therapy | “cell suspension of allogenic adipose-derived stem cells” NCT01372969 ↗ |
| Route | Other | “in the fistula” NCT01372969 ↗ |