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Etavopivat A
Etavopivat A is a Nrf2 activator Small molecule drug developed by Novo Nordisk A/S. It is currently in Phase 3 development for Sickle cell disease.
Etavopivat activates the Nrf2 (nuclear factor erythroid 2-related factor 2) pathway to increase fetal hemoglobin (HbF) production and reduce hemolysis in patients with sickle cell disease.
Etavopivat activates the Nrf2 (nuclear factor erythroid 2-related factor 2) pathway to increase fetal hemoglobin (HbF) production and reduce hemolysis in patients with sickle cell disease. 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). -
Oncology Phase 3 boost
+3.0pp
Oncology Phase 3 trials have higher approval rates (~61%) than the cross-industry average due to clearer endpoints and FDA oncology pathway. -
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 A |
|---|---|
| Sponsor | Novo Nordisk A/S |
| Drug class | Nrf2 activator |
| Target | Nrf2 (NFE2L2) |
| Modality | Small molecule |
| Therapeutic area | Hematology/Oncology |
| Phase | Phase 3 |
Mechanism of action
Etavopivat is an Nrf2 activator that enhances the transcription of genes involved in fetal hemoglobin synthesis. By increasing HbF levels, the drug reduces polymerization of sickle hemoglobin and decreases red blood cell sickling, hemolysis, and vaso-occlusive crises. This mechanism addresses the underlying pathophysiology of sickle cell disease by promoting a compensatory increase in the non-sickling form of hemoglobin.
Approved indications
- Sickle cell disease
Common side effects
- Hyperuricemia
- Gout
- Elevated uric acid levels
Key clinical trials
- A Study to Evaluate the Pharmacokinetics and Safety of Etavopivat in Pediatric Patients With Sickle Cell Disease (PHASE2)
- A Study to Evaluate How Well Etavopivat Works in People With Sickle Cell Disease (PHASE3)
- 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)
- 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)
- Study of the Effect of Etavopivat on Cerebral Hemodynamic Response in Children With Sickle Cell Disease (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 A CI brief — competitive landscape report
- Etavopivat A updates RSS · CI watch RSS
- Novo Nordisk A/S portfolio CI
Frequently asked questions about Etavopivat A
What is Etavopivat A?
How does Etavopivat A work?
What is Etavopivat A used for?
Who makes Etavopivat A?
What drug class is Etavopivat A in?
What development phase is Etavopivat A in?
What are the side effects of Etavopivat A?
What does Etavopivat A target?
Related
- Drug class: All Nrf2 activator drugs
- Target: All drugs targeting Nrf2 (NFE2L2)
- Manufacturer: Novo Nordisk A/S — full pipeline
- Therapeutic area: All drugs in Hematology/Oncology
- Indication: Drugs for Sickle cell disease
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing