Last reviewed 2026-05-28 · How we verify

Etavopivat C

Novo Nordisk A/S · Phase 3 active Small molecule ✓ Verified May 2026

Etavopivat C 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 (to reduce hemolysis and vaso-occlusive crises).

Etavopivat activates the pyruvate dehydrogenase kinase (PDK) inhibitor pathway to reduce hemolysis in sickle cell disease by modulating red blood cell metabolism.

Etavopivat C is being studied as a potential treatment for Sickle Cell Disease and Thalassemia in a clinical trial. The trial, NCT06609226, is sponsored by Novo Nordisk A/S and is investigating the long-term effects of Etavopivat C in people with these conditions.

Likelihood of approval

66.3% vs 58.3% industry baseline

If approved by FDA: likely 2028–2030

Steps remaining: NDA/BLA submission

Confidence: High

Why this estimate

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.

Predicted approval windows by jurisdiction (conditional on FDA approval)

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 C
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 reduced reactive oxygen species in red blood cells. This metabolic shift decreases hemolysis and improves red blood cell survival in patients with sickle cell disease, reducing vaso-occlusive crises and hemolytic anemia.

Approved indications

Sickle cell disease (to reduce hemolysis and vaso-occlusive crises)

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)

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 C CI brief — competitive landscape report
Etavopivat C updates RSS · CI watch RSS
Novo Nordisk A/S portfolio CI

Frequently asked questions about Etavopivat C

What is Etavopivat C?

Etavopivat C is a Pyruvate dehydrogenase kinase inhibitor drug developed by Novo Nordisk A/S, indicated for Sickle cell disease (to reduce hemolysis and vaso-occlusive crises).

How does Etavopivat C work?

Etavopivat activates the pyruvate dehydrogenase kinase (PDK) inhibitor pathway to reduce hemolysis in sickle cell disease by modulating red blood cell metabolism.

What is Etavopivat C used for?

Etavopivat C is indicated for Sickle cell disease (to reduce hemolysis and vaso-occlusive crises).

Who makes Etavopivat C?

Etavopivat C is developed by Novo Nordisk A/S (see full Novo Nordisk A/S pipeline at /company/novo-nordisk).

What drug class is Etavopivat C in?

Etavopivat C belongs to the Pyruvate dehydrogenase kinase inhibitor class. See all Pyruvate dehydrogenase kinase inhibitor drugs at /class/pyruvate-dehydrogenase-kinase-inhibitor.

What development phase is Etavopivat C in?

Etavopivat C is in Phase 3.

What are the side effects of Etavopivat C?

Common side effects of Etavopivat C include Hyperuricemia, Gout, Elevated uric acid levels.

What does Etavopivat C target?

Etavopivat C targets PDK (pyruvate dehydrogenase kinase) and is a Pyruvate dehydrogenase kinase inhibitor.

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 (to reduce hemolysis and vaso-occlusive crises)

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing