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Abdelaziz Fahem։ Novo Nordisk Reports Positive Phase 3 Results for Etavopivat

Abdelaziz Fahem/LinkedIn

Apr 21, 2026, 16:03

Abdelaziz Fahem։ Novo Nordisk Reports Positive Phase 3 Results for Etavopivat

Abdelaziz Fahem, Vice President of Medical Affairs and Clinical Research at Hemara Bio, shared a post on LinkedIn:

“Good news in SCD clinical trials is unfortunately so rare that this one needs to be celebrated as it deserves.

Novo Nordisk has just shared positive phase 3 results with etavopivat, a selective erythrocyte PKR activator, in the HIBISCUS study.

According to the company release, etavopivat met both co-primary endpoints at 52 weeks: a statistically significant reduction in annualised VOC rate and a clinically meaningful increase in haemoglobin.

If confirmed in full peer-reviewed publication, this would represent the first phase 3 demonstration that PKR activation can translate into both hematologic improvement AND crisis reduction in SCD.

Mechanistically, this matters.

By increasing ATP and lowering 2,3-DPG, PKR activation improves red cell energetics and reduces HbS polymerization.

The concept has long been biologically sound BUT the clinical validation at phase 3 level is what changes the conversation.

Compared with other PK activators, prior programs have shown haemoglobin improvements but have struggled to demonstrate robust VOC reduction in pivotal settings.

The apparent dual impact on haemolysis and clinical events is therefore particularly relevant.

Of course, the magnitude of VOC reduction, subgroup consistency, durability, and long-term safety will determine how practice-changing this ultimately becomes.

But for a field that has seen multiple disappointments in recent years, a positive, well-controlled phase 3 signal targeting red cell metabolism is meaningful.

We now await the full dataset.”

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