TheraRadar
Data updated: May 26, 2026

PICATO (ingenol mebutate)

Trial Activity: Declining
Dermatology Approved 2012-01-23
Jump to: Indications Approvals Trials Competitors Safety Patents

Development Insights

LEO Pharma conducting 5 trials (71%)
3 indications explored (Focused)
→ actinic keratosis (5 trials)
→ anogenital warts (1 trials)
→ actinic keratoses (1 trials)
2
Indications
--
Phase 3 Trials
14
Years on Market

Details

Status
Discontinued
First Approved
2012-01-23
Patent Cliff
2033

Pro Metrics

Patent cliff and revenue data

Unlock with Pro
Routes
TOPICAL
Dosage Forms
GEL

Companies

LEO LABS
Active Ingredient: INGENOL MEBUTATE

PICATO Approval History

2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
22 FDA actions from 2012 to 2021 · 1 indication expansions
Mar 2021 SUPPL
Label · Labeling
FDA Letter Label
Dec 2020 SUPPL
Label · Labeling
FDA Letter Label
Feb 2020 SUPPL
Label · Labeling
FDA Letter Label

What PICATO Treats

2 FDA approvals

Originally approved for its first indication in 2012 . Covers 2 distinct patient populations.

  • Other (2)
📋

Clinical Trial Registry

7 trials
Trial Sponsor ID Phase Status Title
NCT02361216 results posted LP0105-1032 Ph 3 completed Efficacy and Safety of Ingenol Mebutate Gel for Actinic Keratosis Applied on Large Area on Face, Scalp or Chest
NCT01998984 results posted LP0105-1020 Ph 2 completed 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
NCT01449513 results posted LP0041-03 Ph 1 completed PEP005 Gel - Biological Effects in Actinic Keratosis Assessed by Reflectance Confocal Microscopy
NCT02124239 LP0105-1034 Ph 1 completed Pharmacokinetics of Ingenol Mebutate Gel in Actinic Keratosis Under Maximum Use Conditions
NCT02377999 EXP-1167 Ph 2 completed Safety and Efficacy of Repeat Use of Picato® 0.05% in the Treatment of Anogenital Warts
NCT02990221 IIS-PICATO 1264 Ph 4 completed Efficacy of Ingenol Mebutate on Actinic Keratoses and Field Cancerization vs Cryotherapy
NCT02251652 results posted GCO 13-0142 Ph 4 completed Safety and Efficacy of Ingenol Mebutate 0.05% Gel When Used After Cryotherapy in the Hypertrophic Actinic Keratoses
🔬

Active Pipeline

Pro

Ongoing clinical trials by development phase

Loading...
⭐

Key Completed Trials

Pro

Completed studies with published results, ranked by significance

Loading...
📊

Trial Timeline

ClinicalTrials.gov ↗ Pro

Full development history with FDA approval milestones

|
Loading...
Understanding FDA Approval Types
Count Type What it means
- ORIG Original approval - drug first enters market
- SUPPL - Efficacy New indication (new disease/condition approved)
- SUPPL - Labeling Label text changes (warnings, dosing updates)
- SUPPL - Manufacturing Production changes (new facility)
- SUPPL - Chemistry Formulation changes (new dosage strength)

Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.

PICATO FDA Label Details

View full patent landscape →
12 OB patents · 2 families · 68 international docs across 22 countries

PICATO Patents & Exclusivity

Latest Patent: May 2033

Patents (12 active)

US9789078 Expires May 15, 2033
US8278292 Expires Jul 6, 2027
US8536163 Expires Dec 18, 2026
US8716271 Expires Dec 18, 2026
US9820959 Expires Dec 18, 2026
US8735375 Expires Dec 18, 2026
US9861603 Expires Dec 18, 2026
US9833429 Expires Dec 18, 2026
US8377919 Expires Dec 18, 2026
US8372827 Expires Dec 18, 2026
US8372828 Expires Dec 18, 2026
US9833428 Expires Dec 18, 2026
Source: FDA Orange Book

Pro Intelligence Preview

Deep insights for PICATO

Revenue Insights

  • • Quarterly revenue tracking
  • • Historical trend analysis

Patent Timeline

  • • Cliff: 2033
  • • 46 active patents

Trial Analysis

  • • 7 total trials
  • • Stage: Declining

Competitive Landscape

  • • Competitor tracking
  • • Same target/indication analysis
Unlock Full Intelligence

Full approval history • All patents • Revenue trends • Competitor analysis

Data Sources

FDA Approval: NDA202833 → Patents: FDA Orange Book → Trials: ClinicalTrials.gov →

Data sourced from official FDA and NIH databases. Click links to verify on original sources.

How We Calculate These Metrics

Trial Activity Stage

Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.

Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.

  • Growth: High proportion of early-phase trials (Phase 1/2), active development
  • Expansion: Significant Phase 3 activity, approaching or pursuing approvals
  • Mature: Substantial Phase 4 post-marketing studies
  • Stable: Mixed phase distribution, steady development
  • Declining: Low active trial ratio, reduced R&D investment