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
| 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 · 1 met primary | ||||||
| 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 | Met primary |
| 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 · 2 met primary | ||||||
| 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 | Met primary |
| Phase 3 | NCT04518995 | Nov 2020 → Apr 2022 | alopecia areata | Concert Pharmaceuticals | Completed | Met primary |
News releases announcing trial results or a regulatory action · 7
| Date | Issuer | Release |
|---|---|---|
| 2026-10-01 | Sun Pharmaceutical Industries, Inc. | Results New LEQSELVI® (deuruxolitinib) Two-Year Data in Severe Alopecia Areata Showed Sustained Efficacy and Safety at EADV Congress 2026 sunpharma.com ↗
Results from the featured oral presentation found that the safety profile of LEQSELVI remained generally consistent with previous clinical experience through up to two years of open-label treatment in adults with severe AA. |
| 2026-03-27 | Sun Pharmaceutical Industries, Inc. | Results Sun Pharma Highlights Advances in Alopecia Areata, Psoriasis, and Acne Research at 2026 AAD Annual Meeting sunpharma.com ↗
Pooled data from THRIVE -AA1 and THRIVE -AA2 pivotal trials of LEQSELVI ™ (deuruxolitinib) in severe alopecia areata demonstrated significant scalp hair regrowth as early as Week 8 and Week 12, with continuous improvements over time. |
| 2024-10-25 | Sun Pharmaceutical Industries, Inc. | Results Sun Pharma Presents LEQSELVI at the 2024 Fall Clinical Dermatology Conference sunpharma.com ↗
Data at 68 weeks of treatment with LEQSELVI showed ongoing and clinically meaningful improvement in scalp hair regrowth |
| 2024-09-26 | Sun Pharmaceutical Industries, Inc. | Results Sun Pharma Presents New Clinical Efficacy and Safety Data in Severe Dermatological Conditions at the 2024 European Academy of Dermatology and Venereology (EADV) Congress sunpharma.com ↗
New data demonstrate improved hair satisfaction in more than 95% of patients taking deuruxolitinib and clinically meaningful improvements in depression and anxiety from baseline to Week 24 |
| 2024-07-26 | Sun Pharmaceutical Industries, Inc. | Regulatory U.S. FDA Approves LEQSELVI™ (deuruxolitinib), an Oral JAK Inhibitor for the Treatment of Severe Alopecia Areata sunpharma.com ↗
the U.S. Food and Drug Administration (FDA) approved LEQSELVI™ (deuruxolitinib) 8 mg tablets for the treatment of adults with severe alopecia areata. |
| 2023-10-06 | Sun Pharmaceutical Industries, Inc. | Regulatory Sun Pharma Announces US FDA Filing Acceptance of New Drug Application For Deuruxolitinib sunpharma.com ↗
Sun Pharma Announces US FDA Filing Acceptance of New Drug Application (NDA) For Deuruxolitinib |
| 2023-03-18 | Sun Pharmaceutical Industries, Inc. | Results Late-Breaking Phase 3 Data at AAD 2023 Show Oral Investigational Medicine Deuruxolitinib Significantly Improved Scalp Hair Regrowth in Alopecia Areata sunpharma.com ↗
Late-Breaking Phase 3 Data at AAD 2023 Show Oral Investigational Medicine Deuruxolitinib Significantly Improved Scalp Hair Regrowth in Alopecia Areata |
All press releases naming this drug 8 releases
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 NCT05468749 ↗ |
| 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 ↗ |