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Palsonify

(Paltusotine)

Small molecule

CCrinetics Pharmaceuticals Inc.

0

Indications

6

Total Trials

1

Active Trials

0

Competitors

1

FDA Application

NDA/BLA/ANDA regulatory filings

9

Patents

Timeline

Expected Milestones

Q1 2030

Phase 3Recruiting

Carcinoid Syndrome

NCT07087054

Clinical

Trials by Indication[1]

Acromegaly5 trials

An Study to Evaluate the Safety and Efficacy of Paltusotine for the Treatment of Acromegaly (ACROBAT Edge)

Completed·CCrinetics Pharmaceuticals Inc.·Phase 2·NCT03789656·47 enrolled

A Study to Evaluate the Safety and Efficacy of Paltusotine for the Treatment of Acromegaly (ACROBAT Evolve)

Completed·CCrinetics Pharmaceuticals Inc.·Phase 2·NCT03792555·13 enrolled

An Open Label, Long-term Extension Study to Evaluate the Safety and Efficacy of CRN00808 in Subjects With Acromegaly (ACROBAT Advance)

Terminated·CCrinetics Pharmaceuticals Inc.·Phase 2·NCT04261712·43 enrolled

Show 2 more trials

A Randomized, Controlled, Multicenter Study to Evaluate the Safety and Efficacy of Paltusotine in Subjects With Non-pharmacologically Treated Acromegaly (PATHFNDR-2)

Terminated·CCrinetics Pharmaceuticals Inc.·Phase 3·NCT05192382·111 enrolled

A Randomized, Controlled, Multi-Center Study to Evaluate the Safety and Efficacy of Paltusotine in Subjects With Acromegaly Treated With Long-acting Somatostatin Receptor Ligands (PATHFNDR-1)

Terminated·CCrinetics Pharmaceuticals Inc.·Phase 3·NCT04837040·58 enrolled

Carcinoid Syndrome1 trial

A Randomized, Parallel Group, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Paltusotine in Adults With Carcinoid Syndrome Due to Well-Differentiated Neuroendocrine Tumors

Recruiting·CCrinetics Pharmaceuticals Inc.·Phase 3·NCT07087054·141 enrolled

Regulatory

FDA Approval Timeline[3]

Sep 25, 2025

PALSONIFY

NDA NDA219070

Sources

References

[1]
ClinicalTrials.gov — 6 trial records for Paltusotine. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Paltusotine compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
OpenFDA — FDA approval records (NDA NDA219070). U.S. Food & Drug Administration.
[4]
FDA Orange Book — Patent and exclusivity data for Palsonify. U.S. Food & Drug Administration.
[5]
SEC EDGAR — Crinetics Pharmaceuticals Inc. company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Company: CCrinetics Pharmaceuticals Inc.

Patent Landscape[4]

Patent Cliff

Jul 12, 2037

Earliest patent expiration — generic entry possible after this date

Patent #Expires

10597377Jul 12, 2037

9896432Jul 12, 2037

11414397Jul 12, 2037

10351547Jul 12, 2037

10875839Jul 12, 2037

4 more patents

10464918Jan 16, 2039

11266641Sep 7, 2041

11957674Sep 7, 2041

12208092Mar 25, 2044

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