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Crinetics Pharmaceuticals celebrates FDA approval of Palsonify, the first oral treatment for acromegaly, enhancing patient care and outcomes.
Palsonify’s approval is based on data collected from two Phase III trials showing Palsonify’s tolerability and reduced symptom burden.
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Crinetics Pharmaceuticals announced Palsonify has received FDA approval for first-line treatment of adults diagnosed with Acromegaly where surgery is not an option or for those who have had an unsatisfactory response to surgery. With its approval Palsonify is the first once-a-day oral treatment for Acromegaly in adults.
"With the FDA approval of our lead therapy Palsonify, today marks a new era for those living with acromegaly and also for Crinetics as a company,” said Scott Struthers, Ph.D., founder and chief executive officer of Crinetics. “We are very pleased to be fulfilling our commitment to transforming patient lives. This approval is the first to come from our deep pipeline of first-in-class, small molecule drugs. This would not be possible without the help and partnership of people living with acromegaly, their caretakers, our employees, and the clinical researchers and health care professionals who contributed to Palsonify’s successful development program. Thank you to all involved.”
Palsonify received approval from FDA based off data collected from both the PATHFNDR-1 and PATHFNDR-2 Phase III pivotal trials.1 The trials evaluated Palsonify’s safety and efficiency in previously treated and medically untreated adults with Acromegaly with Palsonify displaying rapid onset, reliable biochemical control, and sustained efficacy across both trials. Study participants reported reductions in signs and symptoms of Acromegaly and was measured by the Acromegaly Symptom Diasy (ASD), an FDA-aligned patient-reported outcome tool developed to collect meaningful symptoms of those diagnosed with Acromegaly including the following.
Additionally, long-term results from the open-label extension phase of both trials were presented at Endocrine Society’s annual meeting, ENDO 2025, with 91% of patients from PATHFNDR-1 and 97% of participants from PATHFNDR-2 enrolling in the open-label extension phase. The evidence presenting at the meeting displayed Palsonify’s ability to deliver durable IGF-1 control, sustained improvements in patient symptom burden, and a consistent safety profile.1
“The PATHFNDR clinical development program set a new standard for acromegaly treatment by demonstrating the ability of Palsonify to drive both biochemical and symptom control, regardless of the degree of underlying disease severity,” said Dr. Shlomo Melmed, Executive vice president of Medicine and Health Sciences and dean of the Medical Faculty at Cedars-Sinai. “The approval of Palsonify is a significant advancement for our patients, as there is an unmet need for an easy-to-administer and safe therapeutic option with a rapid action and durable response that can consistently manage acromegaly.”
Crinetics is aiming to ensure broad access to Palsonify through close working relations with payers, healthcare providers, and patient advocacy organizations to support anyone who may benefit from the treartment.1 Palsonify is expected to be available in the U.S. in early October of this year.
“For people living with acromegaly, treatment once meant burdensome injections, breakthrough symptoms, and lifestyle sacrifices just to stay on track,” said Jill Sisco, President of Acromegaly Community. “What matters most to our community – maintaining consistent control so the disease doesn’t control us – led us to partner with the FDA on Externally Led Patient-Focused Drug Development meetings. This new treatment reflects that our voices have been heard in shaping the next generation of acromegaly care.”
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