Drugs / CTP-543
CTP-543
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Approved | US (FDA) | LEQSELVI | — | 2024-07-25 | fda.gov ↗ |
Trials 23 · a red edge is where a trial was stopped
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 113 trials | ||||||
| Phase 1 | NCT05478772 | Jul → Aug 2022 | — | Concert Pharmaceuticals | Completed | No outcome recorded |
| Phase 1 | NCT05467709 | Jun 2022 | — | Concert Pharmaceuticals | Completed | No outcome recorded |
| Phase 1 | NCT05467696 | Jun 2022 | — | Concert Pharmaceuticals | Completed | No outcome recorded |
| Phase 1 | NCT05468749 | Jun → Oct 2022 | impaired renal function disease | Concert Pharmaceuticals | Completed | No outcome recorded |
| Phase 1 | NCT05467722 | Jun → Sep 2022 | — | Concert Pharmaceuticals | Completed | No outcome recorded |
| Phase 1 | NCT05192369 | Jan 2022 | — | Concert Pharmaceuticals | Completed | No outcome recorded |
| Phase 1 | NCT04843540 | May → Jun 2021 | — | Concert Pharmaceuticals | Completed | No outcome recorded |
| Phase 1 | NCT04743414 | Mar 2021 | — | Concert Pharmaceuticals | Completed | No outcome recorded |
| Phase 1 | NCT04309643 | Jun 2020 | — | Concert Pharmaceuticals | Completed | No outcome recorded |
| Phase 1 | NCT04092712 | Sep 2019 | — | Concert Pharmaceuticals | Completed | No outcome recorded |
| Phase 1 | NCT03880136 | Mar → Apr 2019 | — | Concert Pharmaceuticals | Completed | No outcome recorded |
| Phase 1 | NCT02960945 | Nov 2016 → Jan 2017 | — | Concert Pharmaceuticals | Completed | No outcome recorded |
| Phase 1 | NCT02777008 | May → Dec 2016 | — | Concert Pharmaceuticals | Completed | No outcome recorded |
| Phase 24 trials | ||||||
| Phase 2 | NCT04784533 | Feb 2021 → May 2023 | alopecia areata | Concert Pharmaceuticals | Completed | No outcome recorded |
| Phase 2 | NCT03941548 | May 2019 → Apr 2020 | alopecia areata | Concert Pharmaceuticals | Completed | No outcome recorded |
| Phase 2 | NCT03811912 | Mar → Nov 2019 | alopecia areata | Concert Pharmaceuticals | Completed | No outcome recorded |
| Phase 2 | NCT03137381 | Aug 2017 → Jul 2019 | alopecia areata | Concert Pharmaceuticals | Completed | No outcome recorded |
| Phase 2/31 trial | ||||||
| Phase 2/3 | NCT03898479 | Apr 2019 → May 2027 expected | alopecia areata | Sun Pharmaceutical Industries, Inc. | Active not recruiting | No outcome recorded |
| Phase 35 trials | ||||||
| Phase 3 | NCT07617597 | Jun 2026 → Feb 2028 expected | alopecia areata | Sun Pharma Japan Limited | Recruiting | No outcome recorded |
| Phase 3 | NCT07133308 | Aug 2025 → May 2028 expected | alopecia areata | Sun Pharmaceutical Industries, Inc. | Recruiting | No outcome recorded |
| Phase 3 | NCT05041803 | Oct 2021 → Jul 2024 | alopecia areata | Sun Pharmaceutical Industries, Inc. | Completed | No outcome recorded |
| Phase 3 | NCT04797650 | Jun 2021 → Jun 2022 | alopecia areata | Concert Pharmaceuticals | Completed | No outcome recorded |
| Phase 3 | NCT04518995 | Nov 2020 → Apr 2022 | alopecia areata | Concert Pharmaceuticals | Completed | No outcome recorded |
Evidence & citations 5 cited values
Every value below carries the sentence it was read from. 23 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | CTP-543 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT04518995 ↗ |
| Known as | Deuruxolitinib | “Efficacy and safety of deuruxolitinib, an oral selective Janus kinase 1/2 inhibitor, in adults with alopecia areata: Results from the THRIVE-AA2 Phase 3, randomized,...” PMID 41317911 ↗ Nov 2025 |
| Known as | Deuruxolitinib Phosphate | “A Phase 1 Study to Assess the Effect of Mild and Moderate Hepatic Impairment on the Pharmacokinetics of CTP-543 (Deuruxolitinib Phosphate)” NCT05467722 ↗1“A Phase 1 Study to Assess the Effect of Moderate Renal Impairment on the Pharmacokinetics of CTP-543 (Deuruxolitinib Phosphate)” NCT05468749 ↗ |
| Action | Inhibit | “deuruxolitinib, an oral selective Janus kinase 1/2 inhibitor” PMID 41317911 ↗ Nov 2025 |
| Route | Oral | “Single oral dose” NCT02777008 ↗ |