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Osivelotor (osivelotor)
Osivelotor (generic name: osivelotor) is a drug developed by Pfizer Inc.. It is currently in Phase 2 development.
Osivelotor is a small molecule investigational drug being developed for the treatment of sickle cell disease and liver diseases. It is currently being studied in clinical trials, including a phase 1 study to learn how the body processes the drug in people with loss of liver function.
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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). -
Big-pharma sponsor
+3.0pp
Pfizer Inc. is a top-20 pharma sponsor — historical approval rates run ~3pp above average due to scale, regulatory experience, and trial-design quality.
| 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 | osivelotor |
|---|---|
| Sponsor | Pfizer Inc. |
| Therapeutic area | Other |
| Phase | Phase 2 |
Approved indications
Common side effects
- Malaria
- Pregnancy
- Pain
- Urinary tract infection
- Upper respiratory tract infection
- Bronchitis
- Lymphadenopathy
- Sickle cell anaemia with crisis
- Vision blurred
- Peptic ulcer
- Dental caries
- Oedema
Key clinical trials
- A Study to Learn How Different Preparations of Osivelotor Taste and Enter the Blood With Food or Liquids or With an Antacid in Healthy Adults (PHASE1)
- A Phase 2/3 Study in Adult and Adolescent Participants With SCD (PHASE2, PHASE3)
- GBT021601-022: A Study of GBT021601 in Participants With Sickle Cell Disease (SCD) (PHASE2, PHASE3)
- A Study to Learn How the Body Processes the Study Medicine Called Osivelotor (PF-07940367) in People With Loss of Liver Function (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:
- Osivelotor CI brief — competitive landscape report
- Osivelotor updates RSS · CI watch RSS
- Pfizer Inc. portfolio CI
Frequently asked questions about Osivelotor
What is Osivelotor?
Who makes Osivelotor?
What is the generic name of Osivelotor?
What development phase is Osivelotor in?
What are the side effects of Osivelotor?
Related
- Manufacturer: Pfizer Inc. — full pipeline
- Therapeutic area: All drugs in Other
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing