Ingenol metabute

ApprovedSmall molecule

LEO Pharma

Ingenol metabute is one of 74 small molecule programs targeting Cheilitis. It is currently in Approved.

Indications

Total Trials

Active Trials

Competitors

Pipeline

Status by Indication[3][1]

Indication

CheilitisActive, not recruiting

Actinic KeratosisActive, not recruiting

Squamous Cell CarcinomaActive, not recruiting

CheilitisPhase 1/Phase 2

Active, not recruiting

Actinic KeratosisPhase 3

Active, not recruiting

Squamous Cell CarcinomaApproved

Active, not recruiting

Competition

Competitive Landscape

279 competitors in Squamous Cell Carcinoma

#DrugCompanyPhaseTrials

Keytruda

Merck & Co.

Phase 3

20 2

Taxol

Teva

Phase 3

11 3

Tecentriq

Roche

Phase 3

6 4

Paraplatin

AAvyxa

Phase 3

19 5

Libtayo

Regeneron

Phase 3

5 6

Yervoy

Bristol-Myers Squibb

Phase 3

4 7

Vectibix

Amgen

Phase 3

3 8

Beyfortus

BeiGene

Phase 3

2 9

Gilotrif

Boehringer Ingelheim

Phase 3

10 10

Tarceva

DDutch Society of Physicians for Pulmonology and Tuberculosis

Phase 3

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

Clinical

Trials by Indication[1]

Actinic Keratosis18 trials

A Sequential Treatment Regimen of Cryotherapy and Picato® for the Treatment of Actinic Keratosis on the Face and Scalp

Completed· LEO Pharma logo

LEO Pharma·Phase 3·NCT01541553·367 enrolled

Pharmacokinetics of Ingenol Mebutate Gel in Actinic Keratosis Under Maximum Use Conditions

Completed· LEO Pharma logo

LEO Pharma·Phase 1·NCT02124239·79 enrolled

Safety and Tolerability of Different Concentrations of an Ingenol Derivative Field Therapy in the Treatment of Actinic Keratosis

Completed· LEO Pharma logo

LEO Pharma·Phase 1·NCT01703078·41 enrolled

Show 15 more trials

Efficacy and Safety of Ingenol Mebutate Gel 0.06% When Applied Once Daily for 2, 3 or 4 Consecutive Days to a Treatment Area of Approximately 250 cm2 on Trunk and Extremities in Subjects With Actinic Keratosis

Completed· LEO Pharma logo

LEO Pharma·Phase 2·NCT01998984·266 enrolled

To Compare Safety and Efficacy of Perrigo's Drug Product Compared to an FDA Approved Drug Product in the Treatment of Actinic Keratosis

Completed·PPadagis LLC·Phase 3·NCT02385318·519 enrolled

An Equivalence Study of Generic Ingenol Mebutate Gel 0.015% and Picato Gel 0.015% in Subjects With Actinic Keratosis

Completed·AActavis Inc.·Phase 3·NCT03200912·507 enrolled

IM Versus 5-FU Versus IMI Versus MAL-PDT in Treatment of Actinic Keratosis

Unknown status·MMaastricht University Medical Center·Phase 4·NCT02281682·624 enrolled

The Use of Picato® (Ingenol Mebutate) to Treat Actinic Keratosis in Standard Clinical Practice

Completed· LEO Pharma logo

LEO Pharma··NCT02594436·440 enrolled

The Real Life Topical Field Treatment of Actinic Keratosis Study

Completed· LEO Pharma logo

LEO Pharma··NCT02362152·1,168 enrolled

A Simultaneous Treatment Regimen Compared to a Sequential Treatment Regimen With Ingenol Mebutate Gel 0.015% and 0.05% of Two Areas With Actinic Keratosis on Face/Scalp and Trunk/Extremities

Completed· LEO Pharma logo

LEO Pharma·Phase 3·NCT01787383·200 enrolled

Safety and Efficacy of Ingenol Mebutate Once Daily for 2 or 3 Consecutive Days in Subjects With Actinic Keratosis

Completed· LEO Pharma logo

LEO Pharma·Phase 1/2·NCT01820260·395 enrolled

A Study of Equivalence of Generic Ingenol Mebutate Gel 0.05% and Picato Gel 0.05% in Subjects With Actinic Keratosis

Completed·AActavis Inc.·Phase 3·NCT02654769·441 enrolled

Efficacy and Safety of Ingenol Mebutate Gel for Actinic Keratosis Applied on Large Area on Face, Scalp or Chest

Completed· LEO Pharma logo

LEO Pharma·Phase 3·NCT02361216·729 enrolled

Clinical Trial of Ingenol Mebutate Gel 0.015% & 0.05% in Actinic Keratosis

Completed·KKorea University·Phase 4·NCT02716714·77 enrolled

TreatMent of ActInic KerAtosis Lesions : pharmacoepiDemiological Study of the Impact in Real Life of ingenOl Mebutate Gel (Picato®) on Patients Satisfaction

Completed· LEO Pharma logo

LEO Pharma··NCT04202445·1,218 enrolled

To Compare Safety and Efficacy of Perrigo's Drug Compared to an FDA Approved Drug in the Treatment of Actinic Keratosis

Completed·PPadagis LLC·Phase 3·NCT02459795·469 enrolled

PEP005 Gel - Biological Effects in Actinic Keratosis Assessed by Reflectance Confocal Microscopy

Completed· LEO Pharma logo

LEO Pharma·Phase 1·NCT01449513·24 enrolled

Safety and Tolerability Study of Ingenol Mebutate Compared to 5-FU to Treat Facial Actinic Keratosis

Completed·UUniversity of Sao Paulo·N/A·NCT02242747·100 enrolled

Actinic Keratoses3 trials

Efficacy of Ingenol Mebutate on Actinic Keratoses and Field Cancerization vs Cryotherapy

Completed·UUniversity of Campania Luigi Vanvitelli·Phase 4·NCT02990221·50 enrolled

Assessment of Treatment Success and Quality of Life in Patients With Actinic Keratoses Under Therapy With Ingenol Mebutate in a Period of 8 Weeks

Completed· LEO Pharma logo

LEO Pharma··NCT02090465·840 enrolled

Histological Confirmation of Clinical Clearance of Actinic Keratoses Following Treatment With Ingenol Mebutate Gel, 0.05%

Completed· LEO Pharma logo

LEO Pharma·Phase 1·NCT01892137·137 enrolled

Safety and Efficacy2 trials

PMS to Evaluate the Safety and Efficacy of Picato® Gel

Completed· LEO Pharma logo

LEO Pharma··NCT02421471·1,324 enrolled

Safety and Efficacy of Ingenol Mebutate 0.05% Gel When Used After Cryotherapy in the Hypertrophic Actinic Keratoses

Completed·IIcahn School of Medicine at Mount Sinai·Phase 4·NCT02251652·16 enrolled

Squamous Cell Carcinoma2 trials

A Trial to Compare the Incidence of Squamous Cell Carcinoma (SCC) and Other Skin Neoplasia on Skin Areas Treated With Ingenol Disoxate Gel or Vehicle Gel for Actinic Keratosis on Face and Chest or Scalp

Terminated· LEO Pharma logo

LEO Pharma·Phase 3·NCT03115476·563 enrolled

Risk of Squamous Cell Carcinoma on Skin Areas Treated With Ingenol Mebutate Gel, 0.015% and Imiquimod Cream, 5%

Completed· LEO Pharma logo

LEO Pharma·Phase 4·NCT01926496·485 enrolled

Skin Lesions1 trial

Ingenol Mebutate Compared to Cryotherapy for the Treatment of Skin Lesions

Withdrawn·NNorthwestern University·Phase 1·NCT01735942

4 more indications

Efficacy and Safety1 trial

Efficacy and Safety of Ingenol Mebutate Gel 0.015% Compared to Diclofenac Sodium Gel 3% in Subjects With Actinic Keratoses on the Face or Scalp

Completed· LEO Pharma logo

LEO Pharma·Phase 4·NCT02406014·502 enrolled

Cheilitis1 trial

Evaluation of Ingenol Mebutate for Actinic Cheilitis Treatment

Withdrawn·IInstituto Nacional de Cancer, Brazil·Phase 1/2·NCT03452566

Multiple Actinic Keratoses1 trial

Ingenol Mebutate Gel, 0.015% Repeat Use for Multiple Actinic Keratoses on Face and Scalp

Completed· LEO Pharma logo

LEO Pharma·Phase 3·NCT01600014·463 enrolled

Solid Organ Transplant Recipients1 trial

Safety and Efficacy of Ingenol Mebutate Gel 0.015% for Treatment of AK on the Face in Solid Organ Transplant Recipients

Completed·UUniversity of California, San Francisco·Phase 4·NCT02866695·20 enrolled

Sources

References

[1]
ClinicalTrials.gov — 30 trial records for Ingenol metabute. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Ingenol metabute compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Ingenol metabute. EMBL-EBI & Wellcome Sanger Institute.
[4]
SEC EDGAR — LEO Pharma company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Highest Phase: Approved[1]
Company: LEO Pharma

Ingenol metabute

Status by Indication[3][1]

Competitive Landscape

Trials by Indication[1]

Actinic Keratosis18 trials

Actinic Keratoses3 trials

Safety and Efficacy2 trials

Squamous Cell Carcinoma2 trials

Skin Lesions1 trial

Efficacy and Safety1 trial

Cheilitis1 trial

Multiple Actinic Keratoses1 trial

Solid Organ Transplant Recipients1 trial

References

Drug Info

Quick Facts

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