Wednesday, July 8, 2026

Drug profile · INN

tirbanibulin

tirbanibulin (KLISYRI) is a tyrosine-protein kinase src inhibitor. Associated with S.A.. Route of administration: topical. Current US regulatory status: approved.

FDA: approved EMA: approved Dermatologicals (D06) D06BX03
US status approved
Patents linked 0
Pipeline programs 2
News articles 0
Drug details — tirbanibulin
US status
approved
Class
Dermatologicals (D06)
Route
TOPICAL
Patents
0
Programs
2
Data quality
0.89

Quick answer

tirbanibulin (KLISYRI) is a tyrosine-protein kinase src inhibitor. Associated with S.A.. Route of administration: topical. Current US regulatory status: approved.

Key facts

INN tirbanibulin
Brand KLISYRI
Mechanism Tyrosine-protein kinase SRC inhibitor
Target Proto-oncogene tyrosine-protein kinase Src
Therapeutic class Dermatologicals (D06)
Route TOPICAL
Formulation OINTMENT
ATC code D06BX03
Originator S.A.

Mechanism of action

Tyrosine-protein kinase SRC inhibitor

Primary target: Proto-oncogene tyrosine-protein kinase Src

Approval history

Authority Status Date
FDA approved
EMA approved

Pipeline programs

  1. M-14867-33 Phase 3 · ALMIRALL S.P.A · Actinic Keratosis on the Face or Scalp
  2. Klisyri 10 mg/g ointment, Solaraze 30 mg/g Gel Approved · ALMIRALL S.P.A · Actinic Keratosis

Related & competitor drugs

  1. beremagene geperpavec Dermatologicals (D03)
  2. dupilumab Dermatologicals (D11)
  3. imiquimod Dermatologicals (D06)
  4. lebrikizumab Dermatologicals (D11)
  5. retapamulin Dermatologicals (D06)
  6. tacrolimus Dermatologicals (D11)

Frequently asked questions

What is tirbanibulin?

tirbanibulin (KLISYRI) is a tyrosine-protein kinase src inhibitor. Associated with S.A.. Route of administration: topical. Current US regulatory status: approved.

What is the brand name for tirbanibulin?

KLISYRI is a marketed brand name for tirbanibulin. Check FDA Drugs@FDA for the current US label holder and prescribing information.

What is the US approval status of tirbanibulin?

tirbanibulin has approved status in the United States according to our Drugs@FDA-derived records. Verify on the official FDA label before clinical or commercial decisions.