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Fosigotifator (ABBV-CLS-7262)Calico—Fosigotifator (ABBV-CLS-7262)Calico—

Fosigotifator (ABBV-CLS-7262)

by CalicoUS

PilotStage 3 of 5

In trials for a rare brain disease (vanishing white matter) with FDA Breakthrough status; failed in ALS.

Updated 23 Jun 2026Checked 25 Sep0 updates this week

Milestones

Next · Finish rare-disease trial
  1. Picked for an FDA pilot program (rare brain disease)DoneComplete.
  2. ALS trial: main goal not metJan 2025Complete.
  3. FDA Breakthrough status for rare brain disease23 Jun 2026Complete.
  4. Finish rare-disease trialNowCurrent milestone.

Most important updates

  • 23 Jun 2026
  • 12 Nov 2025
  • 23 Sep 2025
  • 6 Jan 2025
  • 23 Oct 2024

Upcoming

  1. Nov 2027Vanishing white matter study (NCT05757141) primary completion, per trial registryin about 55 weeks (next)

Current obstacles

  • One alarm, many diseasesThe stuck alarm shows up in many diseases, but so far it only looks helpful in one rare genetic disorder.

Physics limits

  • The alarm exists for a reasonThe stress response pauses protein making to protect cells during infection or protein misfolding. Overriding it everywhere could leave cells exposed, so doses must balance benefit and protection.
  • It has to get into the brainThe target cells sit behind the blood-brain barrier, which keeps out most drugs. Keeping steady brain levels for years limits which molecules and doses can work.
  • Lost myelin doesn't simply regrowRestoring protein making can halt damage, but white matter already destroyed repairs slowly or not at all, so benefit depends on treating early.

How it works

3 parts
An oligodendrocyte (green), the brain support cell that wraps nerves in myelin and is lost in vanishing white matter disease
An oligodendrocyte (green), the brain support cell that wraps nerves in myelin and is lost in vanishing white matter diseasePhoto: Oleg Tsupykov · CC BY-SA 4.0 (opens commons.wikimedia.org)
Alarm

Stressed cells stop making proteins

When cells sense trouble, the integrated stress response switches off the protein-making starter eIF2B. Stuck on, it starves cells of new proteins.

Drug

Hold the starter switch on

Fosigotifator binds eIF2B and keeps it working even while the alarm sounds, so protein making resumes.

Target

Brain white matter first

In vanishing white matter disease, faulty eIF2B genes keep the alarm on in brain support cells, which then lose the myelin coating nerves.

Update log

8 updates

Tue 23 Jun

  • Minor: PressRegulatory

Wed 12 Nov 2025

  • Major: PressPartnership

Tue 23 Sep 2025

  • Minor: RegulatorTest

Mon 6 Jan 2025

  • Minor: PressTest

Wed 23 Oct 2024

  • Minor: RegulatorTest

Mon 13 Mar 2023

  • Minor: RegulatorTest

Mar 2023

  • Minor: PressTest

Wed 22 Sep 2021

  • Minor: RegulatorTest

About Calico

The team behind Fosigotifator (ABBV-CLS-7262)

Calico

Aging biology, stress-pathway drug, AbbVie

Alphabet-backed aging research company founded in 2013 and led by ex-Genentech CEO Art Levinson. It studies aging in animals from yeast to naked mole-rats; its lead drug, fosigotifator, calms a cell stress alarm. AbbVie ended their joint R&D deal in Nov 2025.

  • Fosigotifator failed in an ALS trial (Jan 2025) but won FDA Breakthrough status for a rare brain disease in Jun 2026.
  • AbbVie ended the joint R&D partnership, begun in 2014 and extended in 2021, in Nov 2025 after investing about $1.75B.
Founded
201313 yrs
Headquarters
United States
Status
Subsidiaryof Alphabet
Valuation
Alphabet-owned
Works in
LongevityAnti-aging drugs
Coverage
1 program · 10 updateslatest 23 Jun 2026checked 25 Sep
Primer