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ABBV-CLS-7262
ABBV-CLS-7262 is a Small molecule drug developed by Calico Life Sciences LLC. It is currently in Phase 2 development.
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Baseline phase 2 → approval rate
+15.3pp
Industry-wide phase 2 drugs reach approval ~15.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2031–2034 | — |
| EMA | EU | 2032–2035 | +0.7 yr |
| MHRA | GB | 2032–2035 | +0.7 yr |
| Health Canada | CA | 2032–2036 | +0.9 yr |
| TGA | AU | 2032–2036 | +1.2 yr |
| PMDA | JP | 2032–2036 | +1.5 yr |
| NMPA | CN | 2033–2037 | +2.3 yr |
| MFDS | KR | 2032–2036 | +1.4 yr |
| CDSCO | IN | 2032–2037 | +1.8 yr |
| ANVISA | BR | 2033–2037 | +2.3 yr |
Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).
Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.
At a glance
| Generic name | ABBV-CLS-7262 |
|---|---|
| Sponsor | Calico Life Sciences LLC |
| Modality | Small molecule |
| Phase | Phase 2 |
Approved indications
Common side effects
- Fall
- Constipation
- Headache
- Muscular weakness
- Diarrhoea
- COVID-19
- Post lumbar puncture syndrome
- Salivary hypersecretion
- Dizziness
- Neuromyopathy
- Nausea
- Abdominal pain
Key clinical trials
- HEALEY ALS Platform Trial - Master Protocol (PHASE2, PHASE3)
- Expanded Access to Fosigotifator
- Research Study for Single-Patient Treatment of Cree Leukoencephalopathy/Vanishing White Matter Disease (EARLY_PHASE1)
- HEALEY ALS Platform Trial - Regimen F ABBV-CLS-7262 (PHASE2, PHASE3)
- An Open-Label Exploratory Study of Fosigotifator in Participants With Vanishing White Matter Disease (PHASE1, PHASE2)
- A Study to Assess Adverse Events of Fosigotifator (ABBV-CLS-7262) in Adults With Major Depressive Disorder (PHASE1)
- A Phase 1 Study to Investigate the Safety and Pharmacokinetics of Fosigotifator in Patients With Amyotrophic Lateral Sclerosis (PHASE1)
- Study of [14C] ABBV-CLS-7262 in Healthy Male Volunteers Following Single Oral Dose Administration (PHASE1)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- ABBV-CLS-7262 CI brief — competitive landscape report
- ABBV-CLS-7262 updates RSS · CI watch RSS
- Calico Life Sciences LLC portfolio CI
Frequently asked questions about ABBV-CLS-7262
What is ABBV-CLS-7262?
Who makes ABBV-CLS-7262?
What development phase is ABBV-CLS-7262 in?
What are the side effects of ABBV-CLS-7262?
Related
- Manufacturer: Calico Life Sciences LLC — full pipeline
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing