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NCT04624659 (Etavopivat in Sickle Cell Disease): BVCT ex-ante prediction vs. reported outcome

On 4 Jan 2026, BioinvestGPT's BVCT predicted technical partial success and commercial failure for this trial. The 20 Apr 2026 readout is classified on the dashboard as True Negative (TN), a correct prediction. Recorded clinical-benefit conclusion: statistically significant (probably borderline) and commercially probably insufficient (inferior to hydroxyurea).

Clinical Trial

NCTID
NCT04624659
Acronym
HIBISCUS
Drug Name
Etavopivat
Drug MoA
pyruvate kinase R activator
Drug Modality
small molecule
Drug Class
First-In-Class
Therapeutic Area
Hemic and Lymphatic Diseases
Indication
Sickle Cell Disease
Human Patients
450
Sponsor
Novo Nordisk
Phase
Phase 3

Prediction of , index 2112

Prospective Prediction
Prediction Index
2112
Prediction Date
Commercial Prediction
FAILURE (commercially insufficient (additive) clinical benefit in Hb response rate and annualized vaso-occlusive crisis slightly inferior to the SoC hydroxyurea)
Technical Prediction
partial SUCCESS (statistically maybe significant yet weak (additive) clinical benefit in Hb response rate and annualized vaso-occlusive crisis compared with placebo yet with negative dose-response relationship and moderate toxicity)

Readout of

Prediction Validation
Readout Date
Prediction To Readout
106 days in advance
Readout Data Interpretation
etavopivat achieved statistically significant 27% placebo-adjusted reduction in VOC events and 41.5% placebo-adjusted Hb increase >1 g/dL at week 24 (no p-value disclosed), which are inferior to 44% placebo-adjusted reduction in VOC events and 41.5% placebo-adjusted Hb increase achieved by hydroxyurea (see add'l link below)
Press Release
Additional Readout Data
Prediction Result
Prediction Accuracy
Correct Prediction
Clinical Benefit Conclusion
statistically significant (probably borderline) and commercially probably insufficient (inferior to hydroxyurea)
Prediction Classification
True Negative (TN)

ClinicalTrials.gov record

ClinicalTrials.gov record, retrieved 2026-09-24. Third-party data.

Official title
An Adaptive, Randomized, Placebo-controlled, Double-blind, Multi-center Study of Oral Etavopivat, a Pyruvate Kinase Activator in Patients With Sickle Cell Disease (HIBISCUS)
Phase
Phase 3
Status
Active not recruiting
Enrollment
450
Lead sponsor
Forma Therapeutics, Inc.
Conditions
Sickle Cell Disease
Interventions
DRUG: Etavopivat Tablets Low dose; DRUG: Etavopivat Tablets High dose; DRUG: Placebo Tablets; DRUG: Etavopivat Tablets
Design
Randomized · Parallel · Quadruple
Primary purpose
Treatment
Start
2021-01-29
Primary completion
2026-02-06
Completion
2027-03-19
Primary outcomes
  • Hemoglobin response rate (24 Weeks)
  • Annualized vaso-occlusive crisis (52 Weeks)

NCT04624659 on ClinicalTrials.gov

Return to the dashboardClinicalTrials.gov

How to read these records: evidence · methodology · all trials