Drugs / ABBV-CLS-7262
Trials 6
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 14 trials | ||||||
| Phase 1 | NCT06425003 | May → Jul 2024 | — | Calico Life Sciences LLC | Completed | No outcome recorded |
| Phase 1 | NCT06310876 | Mar → May 2024 | — | Calico Life Sciences LLC | Completed | No outcome recorded |
| Phase 1 | NCT06145607 | Dec 2023 → Jan 2024 | — | Calico Life Sciences LLC | Completed | No outcome recorded |
| Phase 1 | NCT05763459 | Mar → May 2023 | — | Calico Life Sciences LLC | Completed | No outcome recorded |
| Phase 2/32 trials · 1 missed | ||||||
| Phase 2/3 | NCT05740813 | Mar 2023 → Oct 2024 | amyotrophic lateral sclerosis | Merit E. Cudkowicz, MD | Completed | No outcome recorded |
| Phase 2/3 | NCT04297683 | Jun 2020 → Jul 2027 expected | amyotrophic lateral sclerosis | Merit E. Cudkowicz, MD | Recruiting | Missed primary |
News releases announcing trial results or a regulatory action · 2
| Date | Issuer | Release |
|---|---|---|
| 2025-01-06 | Calico Life Sciences LLC | Results Calico Provides Update on Fosigotifator in HEALEY ALS Platform Trial calicolabs.com ↗
The fosigotifator regimen did not meet the study’s primary endpoint of disease progression (a combined analysis of function and mortality) for either the primary or the exploratory high dose. |
| 2024-06-07 | Calico Life Sciences LLC | Regulatory Calico Life Sciences Announces that Fosigotifator (ABBV-CLS-7262) for Vanishing White Matter Disease has been Selected for the FDA START Pilot Program calicolabs.com ↗
Calico is honored that fosigotifator has been selected by CDER as one of three candidates for the FDA’s innovative START Pilot Program. |
All press releases naming this drug 3 releases
| Date | Issuer | Release |
|---|---|---|
| 2025-01-06 | Calico Life Sciences LLC | Calico Provides Update on Fosigotifator in HEALEY ALS Platform Trial calicolabs.com ↗ |
| 2024-06-07 | Calico Life Sciences LLC | Calico Life Sciences Announces that Fosigotifator (ABBV-CLS-7262) for Vanishing White Matter Disease has been Selected for the FDA START Pilot Program calicolabs.com ↗ |
| 2023-04-26 | Calico Life Sciences LLC | Calico Life Sciences Announces First Participant Dosed in Phase 1b Clinical Study Evaluating ABBV-CLS-7262 for the Treatment of Vanishing White Matter Disease calicolabs.com ↗ |
Evidence & citations 2 cited values
Every value below carries the sentence it was read from. 6 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | ABBV-CLS-7262 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT06425003 ↗ |
| Route | Oral | “ABBV-CLS-7262 is administered orally once per day for 24 weeks.” NCT05740813 ↗ |