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Etavopivat B
Etavopivat B is a Pyruvate dehydrogenase kinase inhibitor Small molecule drug developed by Novo Nordisk A/S. It is currently in Phase 3 development for Sickle cell disease (vaso-occlusive crises and hemolysis reduction).
Etavopivat activates the pyruvate dehydrogenase kinase (PDK) inhibitor pathway to reduce hemolysis in sickle cell disease by modulating red blood cell metabolism.
Etavopivat activates the pyruvate dehydrogenase kinase (PDK) inhibitor pathway to reduce hemolysis in sickle cell disease by modulating red blood cell metabolism. Used for Sickle cell disease (vaso-occlusive crises and hemolysis reduction).
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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. -
Big-pharma sponsor
+3.0pp
Novo Nordisk A/S 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 | 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 B |
|---|---|
| Sponsor | Novo Nordisk A/S |
| Drug class | Pyruvate dehydrogenase kinase inhibitor |
| Target | PDK (Pyruvate dehydrogenase kinase) |
| Modality | Small molecule |
| Therapeutic area | Hematology/Rare Blood Disorders |
| Phase | Phase 3 |
Mechanism of action
Etavopivat is a pyruvate dehydrogenase kinase inhibitor that increases pyruvate dehydrogenase activity, leading to increased acetyl-CoA production and enhanced ATP generation in red blood cells. This metabolic shift reduces sickling and hemolysis by improving red blood cell resilience and decreasing vaso-occlusive crises in patients with sickle cell disease.
Approved indications
- Sickle cell disease (vaso-occlusive crises and hemolysis reduction)
Common side effects
- Hyperuricemia
- Gout
- Elevated uric acid levels
Key clinical trials
- A Research Study Looking at Long-term Treatment With Etavopivat in People With Sickle Cell Disease or Thalassaemia (PHASE3)
- A Study on the Effect of Etavopivat on Heart Rhythm in Healthy Participants (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:
- Etavopivat B CI brief — competitive landscape report
- Etavopivat B updates RSS · CI watch RSS
- Novo Nordisk A/S portfolio CI
Frequently asked questions about Etavopivat B
What is Etavopivat B?
How does Etavopivat B work?
What is Etavopivat B used for?
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What development phase is Etavopivat B in?
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What does Etavopivat B target?
Related
- Drug class: All Pyruvate dehydrogenase kinase inhibitor drugs
- Target: All drugs targeting PDK (Pyruvate dehydrogenase kinase)
- Manufacturer: Novo Nordisk A/S — full pipeline
- Therapeutic area: All drugs in Hematology/Rare Blood Disorders
- Indication: Drugs for Sickle cell disease (vaso-occlusive crises and hemolysis reduction)
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing