CDEK
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Paltusotine

Small moleculeapprovedOrphan Drug FDA

Approved

Sep 25, 2025

Clinical trial activity

9 trials · 2 clinical orgs · 1 marketing orgs

Phase 1
2
Phase 2
7
Phase 3
3
Phase 4
0

Earliest trial started Sep 22, 2017 (NCT03276858)

Timeline

2010s

  1. Jan 1, 2017

    Crinetics Pharmaceuticals Inc. — Earliest Phase 1 Sponsor(trial)

  2. Jan 1, 2018

    Crinetics Pharmaceuticals Inc. — Earliest Phase 2 Sponsor(trial)

2020s

  1. Jul 7, 2020

    Orphan Drug Designation

  2. Jan 1, 2021

    Crinetics Pharmaceuticals Inc. — Earliest Phase 3 Sponsor(trial)

  3. Sep 25, 2025

    Earliest FDA Approval

  4. Sep 25, 2025

    Crinetics Pharmaceuticals Inc. — Marketing Organization

Indications

Approved for

Studied for

Mechanism of action

Approval history

  • approvedSep 25, 2025

Chemistry & pharmacology

Loading structure…

SMILES

N#Cc1cccc(-c2ccc3ncc(-c4cc(F)cc(F)c4)c(N4CCC(N)CC4)c3c2)c1O
Mol. weight
456.5 g/mol
Lipinski Ro5
1 violation(s)
Rule of 3
No
Chirality
Achiral Molecule
Inorganic
No
Polymer
No

Oral

No

Parenteral

No

Topical

No

Sources

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT07087054Phase 3Nov 19, 2025Crinetics Pharmaceuticals Inc.
NCT05361668Phase 2Jun 17, 2022Crinetics Pharmaceuticals Inc.
NCT05192382Phase 3Dec 17, 2021Crinetics Pharmaceuticals Inc.
NCT04837040Phase 3May 12, 2021Crinetics Pharmaceuticals Inc.
NCT04246749Phase 1Sep 17, 2019Crinetics Pharmaceuticals Inc.
NCT04261712Phase 2Jan 29, 2019Crinetics Pharmaceuticals Inc.
NCT03789656Phase 2Jan 15, 2019Crinetics Pharmaceuticals Inc.
NCT03792555Phase 2Dec 18, 2018Crinetics Pharmaceuticals Inc.
NCT03276858Phase 1Sep 22, 2017Crinetics Pharmaceuticals Inc., Nucleus Network Ltd
Showing 9 of 9 trials
Page 1 / 1

Organizations

Research & Development (2)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
Crinetics Pharmaceuticals Inc.For profit9932017
Nucleus Network LtdFor profit1012017
2 organizations
Page 1 / 1

Marketing (1)

OrganizationOrg typeRelationshipDate
Crinetics Pharmaceuticals Inc.For profitMKTGSep 25, 2025