drugset
Drugs / Fosigotifator
last change Jun 2026 re-read 3 minutes ago

Fosigotifator

also known as ABBV-CLS-7262 · FGT
Developed for
leukoencephalopathy with vanishing white matter · major depressive disorder · amyotrophic lateral sclerosis
Investigated by
McGill University Health Centre/Research Institute of the McGill University Health Centre · AbbVie · Calico Life Sciences LLC

Trials 4

today NCT07300397 · not/applicable NCT07272525 · Ph 0 NCT06618118 · Ph 1 NCT05757141 · Ph 1/2
202420252026202720282029
PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 01 trial
Phase 0 NCT07272525 Nov 2024 → Nov 2027 expected leukoencephalopathy with vanishing white matter McGill University Health Centre/Research Institute of the McGill University Health Centre Active not recruiting No outcome recorded
Phase 11 trial
Phase 1 NCT06618118 Oct 2024 → Sep 2025 major depressive disorder AbbVie Terminated No outcome recorded
Phase 1/21 trial
Phase 1/2 NCT05757141 Mar 2023 → Nov 2027 expected leukoencephalopathy with vanishing white matter Calico Life Sciences LLC Recruiting No outcome recorded
Phase not applicable1 trial
— NCT07300397 Dec 2025 → Jan 2029 expected leukoencephalopathy with vanishing white matter McGill University Health Centre/Research Institute of the McGill University Health Centre Active not recruiting No outcome recorded
Comparator or background therapy2 trials
Phase 1 NCT04948645 Comparator Sep 2021 → Jul 2025 amyotrophic lateral sclerosis AbbVie Terminated No outcome recorded
— NCT06594016 Background — leukoencephalopathy with vanishing white matter, non-progressive predominantly posterior cavitating leukoencephalopathy with peripheral neuropathy AbbVie No longer available No outcome recorded

News releases announcing trial results or a regulatory action · 3

DateIssuerRelease
2026-06-23 Calico Life Sciences LLC Regulatory Calico Life Sciences Announces Fosigotifator Granted Breakthrough Therapy Designation by the U.S. FDA for the Treatment of Vanishing White Matter Disease calicolabs.com ↗
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 ↗

All press releases naming this drug 4 releases

DateIssuerRelease

Evidence & citations 4 cited values

Every value below carries the sentence it was read from. 6 sources stand behind the page.

FieldValueCited text
Known as Fosigotifator ClinicalTrials.gov intervention name — accepted as the source's own label NCT05757141 ↗
5

NCT07272525 ↗

NCT04948645 ↗

NCT07300397 ↗

NCT06594016 ↗

NCT06618118 ↗
Known as ABBV-CLS-7262 “A new medication called fosigotifator (FGT, ABBV-CLS-7262) is currently being tested in an international clinical trial for VWM.” NCT07300397 ↗
1

“Fosigotifator (FGT/ABBV-CLS-7262)” NCT07272525 ↗
Known as FGT “A new medication called fosigotifator (FGT, ABBV-CLS-7262) is currently being tested in an international clinical trial for VWM.” NCT07300397 ↗
1

“Fosigotifator (FGT/ABBV-CLS-7262)” NCT07272525 ↗
Route Oral “Oral Use” NCT05757141 ↗