> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# Data Backs Pulmonary Hypertension Drug: Merck
- URL: https://www.fdaweb.com/data-backs-pulmonary-hypertension-drug-merck/
- Published: 2022-10-10T12:00:00.000Z
- Updated: 2026-09-14T18:02:29.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5152932

Merck is reporting positive top-line results from a pivotal Phase 3 trial (STELLAR) evaluating the safety and efficacy of sotatercept, an investigational activin receptor Type IIA-Fc fusion protein being studied as an add-on therapy for treating pulmonary arterial hypertension. The company says the trial met its primary efficacy outcome measure and showed a statistically significant and clinically meaningful improvement in six-minute walk distance from baseline at 24 weeks.

Eight of nine secondary efficacy outcome measures also achieved statistical significance, the company says. Sotatercept’s safety profile in STELLAR was consistent with what has been observed in an earlier Phase 2 program, it says, adding that results from the study will be presented at an upcoming scientific congress.

Previously, FDA granted sotatercept a breakthrough therapy designation. Merck says it acquired exclusive rights to sotatercept through the acquisition of Acceleron Pharma, which had a licensing agreement with Bristol Myers Squibb.