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Trade name: Crenessity
Small moleculeapprovedOrphan Drug FDAFast Track FDABreakthrough Therapy FDA
Approved
Dec 13, 2024
Clinical trial activity
3 trials · 1 clinical orgs · 1 marketing orgs
Phase 1
0
Phase 2
3
Phase 3
2
Phase 4
0
Earliest trial started Jul 23, 2020 (NCT04490915)
Timeline
2010s
- Mar 15, 2019
Orphan Drug Designation
2020s
- Jan 1, 2020
Neurocrine Biosciences — Earliest Phase 3 Sponsor(trial)
- Dec 13, 2024
Neurocrine Biosciences — Earliest FDA Approval
- Dec 13, 2024
Neurocrine Biosciences — NDA Organization
- Jan 1, 2025
Neurocrine Biosciences — Earliest Phase 2 Sponsor(trial)
Indications
Approved for
Studied for
Mechanism of action
BAZ1A antagonist
Approval history
- approvedPriority reviewFast trackBreakthroughDec 13, 2024
Chemistry & pharmacology
Oral
No
Parenteral
No
Topical
No
Clinical trials
| NCT ID | Phase | Start date | Sponsor(s) |
|---|---|---|---|
| NCT07187375 | Phase 2 | Sep 30, 2025 | Neurocrine Biosciences |
| NCT04806451 | Phase 3 | Jun 24, 2021 | Neurocrine Biosciences |
| NCT04490915 | Phase 3 | Jul 23, 2020 | Neurocrine Biosciences |
Showing 3 of 3 trials
Page 1 / 1
Organizations
Research & Development (1)
| Organization | Org type | Trials | As lead sponsor | Phases | Earliest year |
|---|---|---|---|---|---|
| Neurocrine Biosciences | For profit | 3 | 3 | 2 | 2020 |
1 organizations
Page 1 / 1
Marketing (1)
| Organization | Org type | Relationship | Date |
|---|---|---|---|
| Neurocrine Biosciences | For profit | NDA | Dec 13, 2024 |