Drug · Small Molecule
Tirbanibulin
CI-DRUG-00000592Explore in graph →NCIt C74077 CHEMBL571546 CIViC Approved
Regulatory
Approvals (2)
Each record names the authority, jurisdiction, indication text and status. A drug approved in one jurisdiction for one indication is not 'approved' in general.
openfdaProvenance
- Source
- openFDA — Drugs@FDA applications and drug labels (SPL)
- Dataset
- Drugs@FDA via openFDA
- Version
- drugsfda-2026-09-11
- Retrieved
- Sep 14, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Evidence
- regulatory
- License
- CC0 1.0 Universal (public domain; https://open.fda.gov/license/)
- Run
- ING-OPENFDA-20260914-000001
| Jurisdiction · authority | Cancer | Indication | Status | Approval date | Source |
|---|---|---|---|---|---|
| US FDA | — | Efficacy supplement 2024-06-07 (see label) | approved | Jun 7, 2024 | openfda |
| US FDA | — | KLISYRI is indicated for the topical field treatment of actinic keratosis on the face or scalp. KLISYRI is a microtubule inhibitor indicated for the topical treatment of actinic keratosis of the face or scalp. ( 1 ) | approved | Dec 14, 2020 | openfda |
Data updated 17 days agoSource updated unknown
Derived
Development pipeline
Most advanced stage across all cancers, then per top-level cancer reached through trial conditions or approval indications. Approval in any ingested jurisdiction outranks trial phase; counts are interventional studies.
| Scope | Stage | Max phase | Active | Recruiting | Phase 3 | Trials | Approvals | Jurisdictions | First approval | First trial |
|---|---|---|---|---|---|---|---|---|---|---|
| All cancers | Approved | Phase 4 | 1 | 1 | 1 | 7 | 2 | US | Dec 14, 2020 | 2007-11 |
| Leukemia | Phase1 | Phase 1 | 0 | 0 | 0 | 1 | 0 | — | — | 2013-12 |
ComputedclinicaltrialsProvenance
- Source
- clinicaltrials
- Layer
- derived (computed by CancerIndex)
Data updated 17 hours ago
Curated evidence
Clinical evidence (1)
CIViC items in which this therapy appears, grouped by cancer context, then molecular profile. 50 items per page.
civicProvenance
- Source
- CIViC — Clinical Interpretation of Variants in Cancer
- Dataset
- CIViC evidence items
- Version
- civic-2026-09-08
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Evidence
- expert curation
- License
- CC0 1.0
- PMID
- 34217323
- Run
- ING-CIVIC-20260908-000001
| Therapy | Cancer | Type | Level | Direction · significance | Rating (1–5) | Status | Evidence | Source |
|---|---|---|---|---|---|---|---|---|
| FLT3 F691L + FLT3 ITD1 | ||||||||
| Tirbanibulin | Acute Myeloid Leukemia | |||||||
Clinical trials
Trials with this intervention (9)
Most recently updated first, 50 per page.
clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Dataset
- ClinicalTrials.gov API v2 studies
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
| NCT | Title | Status | Phase | Enrollment (n) | Sponsor | Countries | Last update | Source |
|---|---|---|---|---|---|---|---|---|
| NCT06135415 | A Study to Evaluate the Efficacy and Safety of Tirbanibulin Ointment in Adult Participants With Actinic Keratosis(TirbAKare) | completed | Phase 3 | 280 | Almirall, S.A.INDUSTRY | 5 | Jun 30, 2026 | clinicaltrials |
| NCT06112522 | Tirbanubulin (Klisiry®) in the Treatment of Basal Cell Carcinoma(Tirbaso) |