FDA, Acromegaly, New Drug Application | Image Credit: © wladimir1804 | stock.adobe.com
_This is an ongoing story._
The FDA has accepted a new drug application (NDA) for paltusotine (Crinetics Pharmaceuticals), an investigational candidate for the treatment and long-term maintenance therapy of adult patients with acromegaly.1 The NDA submission included positive safety and efficacy data from the PATHFNDR-1 (NCT04837040)2 and PATHFNDR-2 (NCT05192382)3 phase 3 clinical trials, which assessed paltusotine in previously treated and medically untreated adult patients with acromegaly.1
If approved by the FDA, the treatment will be the first and only once-daily, oral selective somatostatin receptor type 2 nonpeptide agonist available for patients who have acromegaly. It was previously granted an orphan drug designation by the FDA for the treatment of acromegaly in July 2020.1
“With our patient-centered clinical development of paltusotine, we were guided by an unwavering ambition to deliver a new generation of treatment that provides a once-daily, oral alternative to the currently marketed peptide analog drugs,” said Scott Struthers, PhD, founder and CEO of Crinetics Pharmaceuticals, in a news release. “We look forward to working with the FDA throughout the review of our new drug application…”1
###### **REFERENCES**
###### 1\. GlobeNewswire. Crinetics Announces FDA Acceptance of New Drug Application for Paltusotine for Adult Patients with Acromegaly. News release. December 9, 2024. Accessed Decmeber 9, 2024. https://www.globenewswire.com/news-release/2024/12/09/2993693/0/en/Crinetics-Announces-FDA-Acceptance-of-New-Drug-Application-for-Paltusotine-for-Adult-Patients-with-Acromegaly.html
###### 2\. A Study to Evaluate the Safety and Efficacy of Paltusotine for the Treatment of Acromegaly (PATHFNDR-1). ClinicalTrials.gov identifier: NCT04837040. Updated July 10, 2024. https://clinicaltrials.gov/study/NCT04837040
###### 3\. A Study to Evaluate the Safety and Efficacy of Paltusotine for the Treatment of Acromegaly (PATHFNDR-2) (PATHFNDR-2). ClinicalTrials.gov identifier: NCT05192382. Updated March 29, 2024. Accessed December 9, 2024. https://clinicaltrials.gov/study/NCT05192382