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Etavopivat tablets
Etavopivat tablets is a Protein kinase C (PKC) activator Small molecule drug developed by Forma Therapeutics, Inc.. It is currently in Phase 3 development for Sickle cell disease. Also known as: FT-4202.
Etavopivat activates the protein kinase PKC (protein kinase C) to increase fetal hemoglobin (HbF) production, thereby reducing sickling and hemolysis in red blood cells.
Etavopivat activates the protein kinase PKC (protein kinase C) to increase fetal hemoglobin (HbF) production, thereby reducing sickling and hemolysis in red blood cells. Used for Sickle cell disease.
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Baseline phase 3 → approval rate
+58.3pp
Industry-wide phase 3 drugs reach approval ~58.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas). -
Rare-disease pathway favourability
+5.0pp
Rare-disease drugs benefit from FDA Orphan Drug Act, smaller pivotal trials, and more flexible endpoints. Approval rates run ~5pp above baseline.
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2028–2030 | — |
| EMA | EU | 2029–2031 | +0.7 yr |
| MHRA | GB | 2029–2031 | +0.7 yr |
| Health Canada | CA | 2029–2032 | +0.9 yr |
| TGA | AU | 2029–2032 | +1.2 yr |
| PMDA | JP | 2029–2032 | +1.5 yr |
| NMPA | CN | 2030–2033 | +2.3 yr |
| MFDS | KR | 2029–2032 | +1.4 yr |
| CDSCO | IN | 2029–2033 | +1.8 yr |
| ANVISA | BR | 2030–2033 | +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 | Etavopivat tablets |
|---|---|
| Also known as | FT-4202 |
| Sponsor | Forma Therapeutics, Inc. |
| Drug class | Protein kinase C (PKC) activator |
| Target | PKC (Protein Kinase C) |
| Modality | Small molecule |
| Therapeutic area | Hematology/Rare Blood Disorders |
| Phase | Phase 3 |
Mechanism of action
Etavopivat is a PKC activator that promotes the expression of fetal hemoglobin in erythrocytes. By increasing HbF levels, the drug reduces polymerization of sickle hemoglobin and improves red blood cell survival, thereby decreasing vaso-occlusive crises and hemolytic anemia in patients with sickle cell disease.
Approved indications
- Sickle cell disease
Common side effects
- Headache
- Diarrhea
- Nausea
- Abdominal pain
Key clinical trials
- A Study to Evaluate the Pharmacokinetics and Safety of Etavopivat in Pediatric Patients With Sickle Cell Disease (PHASE2)
- A Research Study Looking at a Single Dose of Etavopivat in Healthy Chinese Participants (PHASE1)
- A Study of Etavopivat in Patients With Thalassemia or Sickle Cell Disease (PHASE2)
- A Study of Etavopivat in Adults and Adolescents With Sickle Cell Disease (HIBISCUS) (PHASE3)
- A Phase 2 Open-label Study to Evaluate the Activity of Etavopivat on Transcranial Doppler Velocities in Pediatric Patients With Sickle Cell Disease Who Are at Increased Risk for Primary Stroke (PHASE2)
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:
- Etavopivat tablets CI brief — competitive landscape report
- Etavopivat tablets updates RSS · CI watch RSS
- Forma Therapeutics, Inc. portfolio CI
Frequently asked questions about Etavopivat tablets
What is Etavopivat tablets?
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Is Etavopivat tablets also known as anything else?
What drug class is Etavopivat tablets in?
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Related
- Drug class: All Protein kinase C (PKC) activator drugs
- Target: All drugs targeting PKC (Protein Kinase C)
- Manufacturer: Forma Therapeutics, Inc. — full pipeline
- Therapeutic area: All drugs in Hematology/Rare Blood Disorders
- Indication: Drugs for Sickle cell disease
- Also known as: FT-4202
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing