Crisaborole

Crisaborole is a phosphodiesterase 4 (PDE-4) inhibitor. PDE-4 inhibition results in increased intracellular cyclic adenosine monophosphate (cAMP) levels.

• EUCRISA is indicated for topical treatment of mild to moderate atopic dermatitis in adult and pediatric patients 3 months of age and older. EUCRISA is a phosphodiesterase 4 inhibitor indicated for topical treatment of mild to moderate atopic dermatitis in adult and pediatric patients 3 months of age and older.ICD-10: L20.9

• EUCRISA is contraindicated in patients with known hypersensitivity to crisaborole or any component of the formulation. [see Warnings and Precautions (5.1) ] Known hypersensitivity to crisaborole or any component of the formulation.contraindicated

Apply a thin layer of EUCRISA twice daily to affected areas. Once clinical effect is achieved, consider reducing application to once daily [see Clinical Studies (14) ] . EUCRISA is for topical use only and not for ophthalmic, oral, or intravaginal use. • Apply a thin layer twice daily to affected areas. ( 2 ) • Once clinical effect is achieved, consider reducing application to once daily. ( 2 ) • For topical use only. ( 2 ) • Not for ophthalmic, oral, or intravaginal use. ( 2 )

Hypersensitivity reactions : If signs and symptoms of hypersensitivity occur, discontinue EUCRISA immediately and initiate appropriate therapy. ( 5.1 ) 5.1 Hypersensitivity Reactions Hypersensitivity reactions, including contact urticaria, have occurred in patients treated with EUCRISA. Hypersensitivity should be suspected in the event of severe pruritus, swelling and erythema at the application site or at a distant site. If signs and symptoms of hypersensitivity occur, discontinue EUCRISA immediately and initiate appropriate therapy.

The most common adverse reaction occurring in ≥1% in subjects is application site pain. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Pfizer Inc. at 1-800-438-1985 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. In two double-blind, vehicle-controlled clinical trials (Trial 1 and Trial 2), 1012 subjects 2 to 79 years of age with mild to moderate atopic dermatitis were treated with EUCRISA twice daily for 4 weeks. The adverse reaction reported by ≥1% of EUCRISA-treated subjects is listed in Table 1. Table 1: Adverse Reaction Occurring in ≥1% of Subjects in Atopic Dermatitis Trials through Week 4 Adverse Reaction EUCRISA Twice Daily N=1012 n (%) Vehicle Twice Daily N=499 n (%) Application site pain Refers to skin sensations such as burning or stinging. 45 (4) 6 (1) Less common (<1%) adverse reactions in subjects treated with EUCRISA included contact urticaria [see Warnings and Precautions (5.1) ]. In one double-blind, vehicle-controlled trial including an initial open-label period (Trial 3), 497 subjects 3 months of age and older with mild to moderate atopic dermatitis received EUCRISA twice daily for up to 8 weeks.

8.1 Pregnancy Risk Summary Available data from case reports with EUCRISA use in pregnant women are insufficient to inform a drug-associated risk for major birth defects, miscarriage, or other adverse maternal or fetal outcomes. In animal reproduction studies, there were no adverse developmental effects observed with oral administration of crisaborole in pregnant rats and rabbits during organogenesis at doses up to 3 and 2 times, respectively, the maximum recommended human dose (MRHD) ( see Data ). The background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies carry some risk of birth defect, loss, or other adverse outcomes. The background risk of major birth defects in the U.S. general population is 2% to 4% and of miscarriage is 15% to 20% of clinically recognized pregnancies. Data Animal Data Rat and rabbit embryo-fetal development was assessed after oral administration of crisaborole. Crisaborole did not cause adverse effects to the fetus at oral doses up to 300 mg/kg/day in pregnant rats during the period of organogenesis (3 times the MRHD on an area under the curve (AUC) comparison basis). No crisaborole-related fetal malformations were noted after oral treatment with crisaborole in pregnant rats at doses up to 600 mg/kg/day (13 times the MRHD on an AUC comparison basis) during the period of organogenesis.

Metabolism

Absorption The PK of EUCRISA were investigated in 33 pediatric subjects 2 to 17 years of age with mild to moderate atopic dermatitis and a mean ± SD body surface area (BSA) involvement of 49 ± 20% (range 27% to 92%). In this study, subjects applied approximately 3 mg/cm 2 of EUCRISA ointment (dose range was approximately 6 g to 30 g per application) twice daily for 8 days.

• Dec 14, 2016NDANDA207695Anacor Pharms Inc

1. 1Drug Ineffective1,97121%
2. 2Application Site Pain1,41615%
3. 3Burning Sensation98510%
4. 4Off Label Use7538.0%
5. 5Condition Aggravated7047.4%
6. 6Pruritus6336.7%
7. 7Rash6066.4%
8. 8Pain5265.6%
9. 9Eczema4514.8%
10. 10Dermatitis Atopic4334.6%
11. 11Erythema3703.9%
12. 12Product Use In Unapproved Indication3343.5%
13. 13Drug Hypersensitivity2602.7%
14. 14Dry Skin2562.7%
15. 15Drug Ineffective For Unapproved Indication2432.6%

The 10 most recently updated of 47 ClinicalTrials.gov registrations naming Crisaborole as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

• Utilization of a Microdevice for Psoriasis and Atopic Dermatitis
  Not yet recruiting · Phase 4 · Interventional · 10 enrolled · University of California, San Francisco
  NCT07352566updated 2026-06-03
• Crisaborole vs Fluticasone Propionate in Mild to Moderate Atopic Dermatitis
  Completed · Interventional · 40 enrolled · Noura Abdelmoneim Mohammed Elseessy
  NCT07537751updated 2026-04-17
• A Randomized Controlled Trial Comparing the Effectiveness and Safety of Topical Tacrolimus 0.03% Versus Crisaborole 2% in Patients With Mild to Moderate Atopic Dermatitis Over 8 Weeks
  Not yet recruiting · Interventional · 72 enrolled · Foundation University Islamabad
  NCT07519174updated 2026-04-09
• Efficacy of Crisaborole 2% Cream Versus Placebo in Mild to Moderate Atopic Eczema
  Not yet recruiting · Phase 4 · Interventional · 270 enrolled · Jinnah Postgraduate Medical Centre
  NCT07438509updated 2026-03-06
• Comparative Evaluation of the Safety and Effectiveness of Crisaborole Ointment (2%) Versus Tacrolimus Ointment (0.1%) for the Topical Treatment of Atopic Dermatitis
  Not yet recruiting · Phase 4 · Interventional · 148 enrolled · Hayat Abad Medical Complex, Peshawar
  NCT07437534updated 2026-03-02
• Comparative Study of Crisaborole vs. Tacrolimus in Atopic Dermatitis
  Not yet recruiting · Phase 4 · Interventional · 30 enrolled · Cairo University
  NCT07367932updated 2026-01-26
• Crisaborole 2% Versus Tacrolimus 0.1% in Children With Mild to Moderate Atopic Dermatitis
  Not yet recruiting · Phase 3 · Interventional · 66 enrolled · Shalamar Institute of Health Sciences
  NCT07162896updated 2025-09-09
• Microneedling Combined With Topical Crisaborole 2 % Ointment in Treatment of Vitiligo.
  Not yet recruiting · Interventional · 20 enrolled · Tanta University
  NCT07088276updated 2025-07-30
• Skin bioMARkers for Atopic Eczema Therapy Evaluation
  Completed · Phase 2 · Interventional · 37 enrolled · Sheffield Teaching Hospitals NHS Foundation Trust
  NCT04194814updated 2025-07-18
• Eucrisa for Atopic Dermatitis
  Completed · Phase 1 · Interventional · 28 enrolled · Wake Forest University Health Sciences
  NCT03250663updated 2025-07-02

Frequently asked questions

How does Crisaborole work?

Crisaborole is a phosphodiesterase 4 (PDE-4) inhibitor. PDE-4 inhibition results in increased intracellular cyclic adenosine monophosphate (cAMP) levels.

What is Crisaborole used for?

According to FDA labeling, Crisaborole carries indications including: EUCRISA is indicated for topical treatment of mild to moderate atopic dermatitis in adult and pediatric patients 3 months of age and older. EUCRISA is a phosphodiesterase 4 inhibitor indicated for topical treatment of mild to moderate atopic dermatitis in adult and pediatric patients 3 months of age and older.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.

What class of drug is Crisaborole?

Crisaborole is classified as Agents for dermatitis, excluding corticosteroids, Phosphodiesterase 4 Inhibitor, Phosphodiesterase 4 Inhibitors, Unknown Physiological Effect.

What are the brand names for Crisaborole?

Crisaborole is marketed under brand names including Eucrisa.

What are the contraindications for Crisaborole?

Crisaborole labeling lists contraindications including: EUCRISA is contraindicated in patients with known hypersensitivity to crisaborole or any component of the formulation. [see Warnings and Precautions (5.1) ] Known hypersensitivity to crisaborole or any component of the formulation.. Always consult the full prescribing information and a clinician.