PALSONIFY

Launch

paltusotine

NDAORALTABLET
Approved
Sep 2025
Lifecycle
Launch
Competitive Pressure
0/100
Clinical Trials
7

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.…

Clinical Trials (5)

NCT07087054Phase 3Recruiting

Carcinoid Syndrome Efficacy Study Featuring an Oral Daily Paltusotine Regimen

Started Nov 2025
141 enrolled
Carcinoid SyndromeCarcinoidCarcinoid Tumor+6 more
NCT05361668Phase 2Active Not Recruiting

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
NCT05192382Phase 3Active Not Recruiting

A Study to Evaluate the Safety and Efficacy of Paltusotine for the Treatment of Acromegaly (PATHFNDR-2)

Started Dec 2021
111 enrolled
Acromegaly
NCT04837040Phase 3Active Not Recruiting

A Study to Evaluate the Safety and Efficacy of Paltusotine for the Treatment of Acromegaly

Started May 2021
58 enrolled
Acromegaly
NCT04261712Phase 2Active Not Recruiting

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

Loss of Exclusivity

LOE Date
Mar 25, 2044
219 months away
Patent Expiry
Mar 25, 2044
Exclusivity Expiry
Sep 25, 2030

Patent Records (5)

Patent #ExpiryTypeUse Code
10351547
Jul 12, 2037
SubstanceProduct
U-4283
10597377
Jul 12, 2037
SubstanceProduct
U-4283
10875839
Jul 12, 2037
U-4283
11414397
Jul 12, 2037
SubstanceProduct
U-4283
9896432
Jul 12, 2037
SubstanceProduct
U-4283