Klisyri

(Tirbanibulin)

ApprovedSmall molecule

AAlmirall, S.A.

Klisyri is one of 25 small molecule programs targeting Carcinoma. It is currently in Approved.

Indications

Total Trials

Active Trials

Competitors

FDA Application

NDA/BLA/ANDA regulatory filings

Patents

Pipeline

Status by Indication[3][1]

Indication

CarcinomaRecruiting

Actinic KeratosisWithdrawn

CarcinomaPhase 2

Recruiting

Actinic KeratosisApproved

Withdrawn

Competition

Competitive Landscape

22 competitors in Carcinoma

#DrugCompanyPhaseTrials

Afinitor

Novartis

Phase 3

1 2

Klisyri

AAlmirall, S.A.

Approved

1 3

Fludara

Sanofi

Phase 2

1 4

Cytoxan

BBaxter Healthcare Corporation

Phase 2

1 5

TQB3454

Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

Phase 3

1 6

MS Contin

HHikma Pharmaceuticals LLC

Preclinical

1 7

Administration of AVP

AAssistance Publique - Hôpitaux de Paris

Preclinical

1 8

SZ011 CAR-NK

SShantou University Medical College

Phase 1

1 9

Ga-NOTA-T4

RRenJi Hospital

Preclinical

1 10

F-RESCA-T4

RRenJi Hospital

Preclinical

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q3 2027

Post-ApprovalActive, not recruiting

Actinic Keratosis

NCT05387525

Q4 2027

Phase 2Recruiting

Carcinoma

NCT06112522

Clinical

Trials by Indication[1]

Actinic Keratosis3 trials

Tirbanibulin 1% Ointment for the Treatment of Actinic Keratosis on the Back of the Hands

Withdrawn·MMedical University of Graz·Phase 4·NCT06026358

A Study of Tirbanibulin Ointment and Diclofenac Sodium Gel for the Treatment of Adult Participants With Actinic Keratosis on the Face or Scalp

Active, not recruiting·AAlmirall, S.A.·Phase 4·NCT05387525·447 enrolled

Patient and Clinician Reported Outcomes for Tirbanibulin Effectiveness and Safety in Actinic Keratosis

Completed·AAlmirall, S.A.··NCT05260073·300 enrolled

Actinic Keratoses1 trial

A Study of Tirbanibulin on the Wellbeing of Participants With Actinic Keratoses

Completed·AAlmirall, S.A.·Phase 4·NCT05741294·334 enrolled

Treatment1 trial

Tirbanibulin 1% Ointment for the Treatment of Chronically Sun-damaged Skin on the Face

Completed·MMedical University of Graz·Phase 4·NCT05900258·22 enrolled

Keratosis, Actinic1 trial

A Phase 3, Multicentre, Randomised, Double-blind, Vehicle-controlled, Parallel-group Study to Evaluate the Efficacy and Safety of Tirbanibulin 10 mg/g Ointment Applied to a Treatment Field Larger Than 25 cm^2 and up to 100 cm^2 in Adult Patients With Actinic Keratosis

Completed·AAlmirall, S.A.·Phase 3·NCT06135415·280 enrolled

Carcinoma1 trial

Open, Prospective Study Evaluating the Efficacy and Safety of 0.05% Tirbanubulin (Klisiry®) in the Treatment of Basal Cell Carcinoma

Recruiting·CCentre Hospitalier Universitaire de Nice·Phase 2·NCT06112522·50 enrolled

Regulatory

FDA Approval Timeline[4]

Dec 14, 2020

KLISYRI

NDA NDA213189

Sources

References

[1]
ClinicalTrials.gov — 7 trial records for Tirbanibulin. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Tirbanibulin compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Tirbanibulin. EMBL-EBI & Wellcome Sanger Institute.
[4]
OpenFDA — FDA approval records (NDA NDA213189). U.S. Food & Drug Administration.
[5]
FDA Orange Book — Patent and exclusivity data for Klisyri. U.S. Food & Drug Administration.
[6]
SEC EDGAR — Almirall, S.A. company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Highest Phase: Approved[1]
Company: AAlmirall, S.A.

Patent Landscape[5]

Patent Cliff

Dec 28, 2027

Earliest patent expiration — generic entry possible after this date

Patent #Expires

10323001Dec 28, 2027

7851470Feb 2, 2029

7300931Dec 28, 2030

12667576Mar 11, 2038

11497750Mar 12, 2038

2 more patents

10617693Mar 12, 2038

10669236Sep 7, 2038

Klisyri

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q3 2027

Q4 2027

Trials by Indication[1]

Actinic Keratosis3 trials

Actinic Keratoses1 trial

Treatment1 trial

Keratosis, Actinic1 trial

Carcinoma1 trial

FDA Approval Timeline[4]

References

Drug Info

Quick Facts

Patent Landscape[5]

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