Palsonify

(Paltusotine)

Phase 3Small molecule

CCrinetics Pharmaceuticals Inc.

Palsonify is one of 26 small molecule programs targeting Carcinoid Syndrome. It is currently in Phase 3.

Indications

Total Trials

Active Trials

Competitors

FDA Application

NDA/BLA/ANDA regulatory filings

Patents

Pipeline

Status by Indication[3][1]

Indication

Carcinoid SyndromeActive, not recruiting

AcromegalyActive, not recruiting

Carcinoid SyndromePhase 3

Active, not recruiting

AcromegalyPhase 3

Active, not recruiting

Competition

Competitive Landscape

39 competitors in Acromegaly

#DrugCompanyPhaseTrials

Sandostatin

Sun Pharma

Approved

7 2

Lanreotide Acetate

AAlbireo, an Ipsen Company

Approved

5 3

Sandostatin LAR

Novartis

Approved

3 4

Octreotide Depot

Novartis

Approved

1 5

Signifor

RRECORDATI GROUP

Phase 3

4 6

Pasireotide LAR

Novartis

Phase 3

4 7

Debio 025

DDebiopharm International SA

Phase 3

1 8

Palsonify

CCrinetics Pharmaceuticals Inc.

Phase 3

5 9

Clomid

Ferring

Phase 2

1 10

Sandostatin LAR Depot

Novartis

Phase 3

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q2 2027

Phase 3Active, not recruiting

Acromegaly

NCT04837040

Q1 2028

Phase 3Active, not recruiting

Acromegaly

NCT05192382

Phase 2Active, not recruiting

Acromegaly

NCT04261712

Q1 2030

Phase 3Recruiting

Carcinoid Syndrome

NCT07087054

Clinical

Trials by Indication[1]

Acromegaly5 trials

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

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

Active, not recruiting·CCrinetics Pharmaceuticals Inc.·Phase 3·NCT04837040·58 enrolled

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

Active, not recruiting·CCrinetics Pharmaceuticals Inc.·Phase 3·NCT05192382·111 enrolled

Show 2 more 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

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

Active, not recruiting·CCrinetics Pharmaceuticals Inc.·Phase 2·NCT04261712·43 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[4]

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]
Open Targets Platform — Drug–disease associations for Paltusotine. EMBL-EBI & Wellcome Sanger Institute.
[4]
OpenFDA — FDA approval records (NDA NDA219070). U.S. Food & Drug Administration.
[5]
FDA Orange Book — Patent and exclusivity data for Palsonify. U.S. Food & Drug Administration.
[6]
SEC EDGAR — Crinetics Pharmaceuticals Inc. company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Highest Phase: Phase 3[1]
Company: CCrinetics Pharmaceuticals Inc.

Patent Landscape[5]

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

Palsonify

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q2 2027

Q1 2028

Q1 2030

Trials by Indication[1]

Acromegaly5 trials

Carcinoid Syndrome1 trial

FDA Approval Timeline[4]

References

Drug Info

Quick Facts

Patent Landscape[5]

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