tirbanibulin
Trade name: Klisyri
Small moleculeapproved
Approved
Dec 14, 2020
Clinical trial activity
11 trials · 6 clinical orgs · 2 marketing orgs
Phase 1
1
Phase 2
6
Phase 3
3
Phase 4
5
Earliest trial started Jun 28, 2022 (NCT05279131)
Timeline
2020s
- Dec 14, 2020
Almirall — Earliest FDA Approval
- Dec 14, 2020
Athenex, Inc. — Marketing Organization
- Dec 14, 2020
Almirall — Marketing Organization
- Dec 14, 2020
Almirall — NDA Secondary Org
- Dec 14, 2020
Almirall — NDA Organization
- Jan 1, 2022
- Jan 1, 2023
Earliest Phase 2 Sponsor(trial)
- Jan 1, 2025
Earliest Phase 1 Sponsor(trial)
Indications
Approved for
Mechanism of action
- TubulinANTAGONIST
Tubulin antagonist
Approval history
- approvedDec 14, 2020
Chemistry & pharmacology
Oral
No
Parenteral
No
Topical
No
Clinical trials
| NCT ID | Phase | Start date | Sponsor(s) |
|---|---|---|---|
| NCT07273656 | Phase 3 | Nov 30, 2025 | Almirall, University of Lille |
| NCT07010692 | Phase 1/Phase 2 (Phase 2) | May 16, 2025 | Bruce Robinson, MD |
| NCT06791525 | Phase 4 | Mar 1, 2025 | — |
| NCT06135415 | Phase 3 | Dec 31, 2023 | Almirall |
| NCT06112522 | Phase 2 | Dec 1, 2023 | University of Nice Sophia Antipolis |
| NCT06026358 | Phase 4 | Oct 31, 2023 | Almirall, Medical University of Graz |
| NCT05900258 | Phase 4 | May 11, 2023 | Medical University of Graz |
| NCT05713760 | Phase 2 | Apr 17, 2023 | Austin Institute for Clinical Research |
| NCT05741294 | Phase 4 | Jan 17, 2023 | Almirall |
| NCT05387525 | Phase 4 | Oct 24, 2022 | Almirall |
| NCT05279131 | Phase 3 | Jun 28, 2022 | Almirall |
Showing 11 of 11 trials
Page 1 / 1
Organizations
Research & Development (6)
| Organization | Org type | Trials | As lead sponsor | Phases | Earliest year |
|---|---|---|---|---|---|
| Almirall | For profit | 6 | 4 | 2 | 2022 |
| Medical University of Graz | Academic/Hospital | 2 | 2 | 1 | 2023 |
| Austin Institute for Clinical Research | For profit | 1 | 1 | 1 | 2023 |
| Bruce Robinson, MD | Academic/Hospital | 1 | 1 | 1 | 2025 |
| University of Lille | Academic/Hospital | 1 | 1 | 1 | 2025 |
| University of Nice Sophia Antipolis | Academic/Hospital | 1 | 1 | 1 | 2023 |
6 organizations
Page 1 / 1
Marketing (4)
| Organization | Org type | Relationship | Date |
|---|---|---|---|
| Almirall | For profit | MKTG | Dec 14, 2020 |
| Almirall | For profit | NDA2 | Dec 14, 2020 |
| Almirall | For profit | NDA | Dec 14, 2020 |
| Athenex, Inc. | For profit | MKTG | Dec 14, 2020 |