Pfizer Initiates Phase II Clinical Trial of PF-07868489 for Pulmonary Arterial Hypertension

Data from the Drug Clinical Trial Registration and Information Disclosure Platform shows that a Phase II, open-label extension study evaluating the safety and efficacy of PF-07868489 administration in adult participants with pulmonary arterial hypertension, conducted by Pfizer Inc./Pfizer (China) Research and Development Co., Ltd./Wyeth BioPharma Division of Wyeth Pharmaceuticals LLC, has been initiated. The clinical trial registration number is CTR20254000, with the initial information disclosure date on October 9, 2025.

The drug formulation is an injectable, administered once every 4 weeks via subcutaneous injection, with a treatment duration of 111 weeks. The primary objective of this trial is to evaluate the long-term safety, tolerability, and efficacy of PF-07868489 SC repeated dosing in PAH study participants.

PF - 07868489 is a biologic product indicated for pulmonary arterial hypertension. Pulmonary arterial hypertension refers to a hemodynamic and pathophysiological condition where the pressure in the pulmonary arteries rises above a certain threshold, with symptoms including shortness of breath, fatigue, dizziness, etc., and diagnosis relies on echocardiography, right heart catheterization, etc.

The primary endpoint indicators of this trial include the number of investigators participating in the study who report treatment-emergent AE and SAE; the number of study participants with changes in clinical laboratory test values from baseline; and the number of study participants with changes in vital signs from baseline. Secondary endpoint indicators include the number of study participants with changes in electrocardiogram (ECG) parameters from baseline; the number of study participants with changes in NT-pro-BNP from baseline; the minimum blood drug concentration (if data permits); and the incidence of anti-drug antibodies (ADA).

Currently, the trial status is ongoing (not yet recruiting), with a target enrollment of 12 participants in China and 36 participants internationally.

Risk Warning: The market involves risks, and investments should be made with caution. This article is automatically published by an AI large model based on a third-party database. Any information appearing in this article (including but not limited to individual stocks, comments, forecasts, charts, indicators, theories, or any form of expression, etc.) is for reference only and does not constitute personal investment advice. Due to issues such as the quality of the third-party database, we are unable to verify or confirm the authenticity and completeness of the data. Therefore, the content of this article may contain inaccuracies, incompleteness, or misleading information, and specific details should be based on official company announcements. If you have any questions, please contact biz@staff.sina.com.cn.

Editorial Responsibility: Xiaolang Express