Sovateltide Shows 92% Success Rate in Phase IV Stroke Trial, Demonstrating Significant Functional Recovery
核心洞察
Pharmazz's Phase IV interim analysis of sovateltide (Tycamzzi®) in 80 acute ischemic stroke patients showed 92.3% achieved favorable functional outcomes compared to 58.5% in controls.
The endothelin-B receptor agonist demonstrated an absolute 33% increase in favorable outcomes with an odds ratio of 8.50 and no drug-related adverse events.
Over 100,000 patients have been treated with sovateltide since its India launch in September 2023, while a global Phase III trial is underway across multiple countries.
Pharmazz, Inc. announced positive interim results from its Phase IV clinical study of sovateltide (Tycamzzi®) in patients with acute cerebral ischemic stroke at the International Stroke Conference 2026 in New Orleans. The multicenter, randomized, controlled trial conducted in India evaluated the real-world safety and effectiveness of the first-in-class, highly selective endothelin-B (ET-B) receptor agonist when administered within 24 hours of stroke onset.
Significant Functional Improvement Demonstrated
The prespecified interim analysis included 80 patients (39 sovateltide; 41 control) who completed 90-day follow-up assessments. Results showed clinically and statistically significant improvement in functional outcomes among patients treated with sovateltide. A remarkable 92.3% of sovateltide-treated patients achieved a modified Rankin Scale (mRS) score of 0–2 at Day 90, compared with 58.5% in the control group, yielding an odds ratio of 8.50 (95% CI 2.44–29.01; p=0.0005).
The treatment demonstrated an absolute 33% increase in favorable functional outcomes (mRS 0–2) compared to controls. Additionally, 84.6% of sovateltide-treated patients achieved an improvement of ≥2 points on the mRS, compared with 51.2% in controls (p=0.0014). Baseline characteristics, including age, NIHSS score, and time from stroke onset to treatment, were comparable between groups.
Safety Profile Remains Favorable
No drug-related adverse events were observed during the study period, and safety outcomes remained consistent with prior studies. The Phase IV study (NCT05955326) enrolled patients aged 18–78 years with radiologically confirmed ischemic stroke and NIHSS ≥6. Participants were randomized to receive either sovateltide (0.3 µg/kg) or saline placebo, administered as three intravenous bolus doses over one minute at 3±1 hour intervals on Days 1, 3, and 6.
Real-World Evidence and Global Expansion
Sovateltide is approved for marketing in India and was launched in September 2023. To date, over 100,000 patients have been treated with the drug, which has demonstrated neuroprotective, pro-angiogenic, and neurogenic effects across preclinical and clinical studies. The compound maintains a favorable safety profile across its clinical development program.
A global Phase III randomized, double-blind, placebo-controlled trial (RESPECT-ETB; NCT05691244) is currently underway across the United States, Europe, the United Kingdom, and Australia, evaluating sovateltide in more than 500 patients with acute ischemic stroke. This international expansion represents a significant step toward broader regulatory approval and patient access to the therapy.