TheraRadar
Data updated: Nov 8, 2026

CRISABOROLE · MACLEODS PHARMS

Generic · see EUCRISA Trial Activity: Mature 1 active trials
Immunology Approved 2016-12-14

CRISABOROLE is FDA-approved to treat 1 condition (same as EUCRISA).

Source: FDA Label
Jump to: Indications Approvals Trials Competitors Safety Patents

Development Insights

University of California, San Francisco conducting 1 trials (17%)
5 indications explored (Moderate)
→ atopic dermatitis (4 trials)
→ eczema (2 trials)
→ psoriasis (1 trials)
1
Indication
--
Phase 3 Trials
9
Years on Market

Details

Status
Prescription
First Approved
2016-12-14
Routes
TOPICAL
Dosage Forms
OINTMENT

Companies

MACLEODS PHARMS
Active Ingredient: CRISABOROLE

CRISABOROLE Approval History

Original
New Indication
New Form
Label Update
1 FDA actions from 2026 to 2026
Sep 2026 ORIGINAL
Update
FDA Letter

What CRISABOROLE Treats

1 indications

CRISABOROLE is approved for 1 conditions since its original approval in 2026. These indications span multiple therapeutic areas including oncology, immunology, and more.

Same approved indications as EUCRISA (same active ingredient).

Source: FDA Label
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Clinical Trial Registry

6 trials
Trial Sponsor ID Phase Status Title
NCT07352566 25-43621 Ph 4 not yet recruiting Utilization of a Microdevice for Psoriasis and Atopic Dermatitis
NCT03832010 results posted IRB00178631 Ph 4 completed Steroid-reducing Effects of Crisaborole
NCT03645057 results posted RSRB73062 Ph 3 completed ASPIRE: PROs & Caregiver Burden in Children With Atopic Dermatitis
NCT04023084 2019-2879 Ph 4 completed Response of Children With Atopic Dermatitis (Eczema) to Eucrisa
NCT03567980 results posted 180306 Ph 4 completed A Proof of Concept Clinical Trial Evaluating the Safety and Efficacy of Eucrisa (Crisaborole) in Patients With Seborrheic Dermatitis
NCT03351114 results posted Pro00086947 Ph 2 completed Pilot Study Evaluating the Efficacy of a Topical PDE4 Inhibitor for Morphea
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Active Pipeline

Pro

Ongoing clinical trials by development phase

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Key Completed Trials

Pro

Completed studies with published results, ranked by significance

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Trial Timeline

ClinicalTrials.gov ↗ Pro

Full development history with FDA approval milestones

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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.

CRISABOROLE FDA Label Details

Indications & Usage

CRISABOROLE is FDA-approved to treat 1 condition — same approved indications as EUCRISA.

Looking for the branded version?

EUCRISA

Full clinical data, patents, trials, and competitive landscape for crisaborole.

See EUCRISA

Data Sources

FDA Approval: ANDA216242 → 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