NDAORALTABLET
Approved
Sep 2025
Lifecycle
Launch
Competitive Pressure
0/100
Clinical Trials
7
Data completeness
5/8 — Partial
PALSONIFY (paltusotine) by Crinetics Pharmaceuticals is somatostatin, paltusotine suppresses growth hormone (gh) and insulin-like growth factor-1 (igf-1) secretion. First approved in 2025.
Drug data last refreshed 48m ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
PALSONIFY (paltusotine) is an oral, selective somatostatin receptor 2 (SSTR2) agonist that suppresses growth hormone (GH) and insulin-like growth factor-1 (IGF-1) secretion with >4000-fold selectivity. It represents a first-in-class oral somatostatin agonist approved by the FDA on September 25, 2025. The drug is indicated for acromegaly and other GH/IGF-1-mediated disorders.
Growth17.5 years to LOE
Recent launch with zero competitive pressure creates aggressive market expansion opportunities for commercial and field teams.
Mechanism of Action
somatostatin, paltusotine suppresses growth hormone (GH) and insulin-like growth factor-1 (IGF-1) secretion. Paltusotine exerts its pharmacological activity via selective agonism (>4000-fold) at somatostatin receptor 2 (SSTR2) and exhibits little or no affinity for other SST receptor subtypes.…
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (7)
Carcinoid Syndrome Efficacy Study Featuring an Oral Daily Paltusotine Regimen
Started Nov 2025
141 enrolled
Carcinoid SyndromeCarcinoidCarcinoid Tumor+6 more
Study to Evaluate the Safety, PK, and Dose Response of Paltusotine in Subjects With Carcinoid Syndrome
Started Apr 2022
36 enrolled
Carcinoid SyndromeCarcinoidCarcinoid Tumor+6 more
A Study to Evaluate the Safety and Efficacy of Paltusotine for the Treatment of Acromegaly (PATHFNDR-2)
Started Dec 2021
111 enrolled
Acromegaly
A Study to Evaluate the Safety and Efficacy of Paltusotine for the Treatment of Acromegaly
Started May 2021
58 enrolled
Acromegaly
A Study to Evaluate the Long-Term Safety and Efficacy of Paltusotine for the Treatment of Acromegaly (ACROBAT Advance)
Started Jan 2020
43 enrolled
Acromegaly
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.