TheraRadar
Data updated: May 26, 2026

ZYCLARA (imiquimod)

Interferon Inducers
Dermatology Approved 2010-03-25

ZYCLARA is indicated for the treatment of Actinic Keratosis; Genital Warts; Perianal Warts.

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

How ZYCLARA Works

The mechanism of action of Zyclara in the treatment of actinic keratosis and external genital warts is unknown.

Source: FDA Label
3
Indications
--
Phase 3 Trials
16
Years on Market

Details

Status
Prescription
First Approved
2010-03-25
Patent Cliff
2030

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Patent cliff and revenue data

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Routes
TOPICAL
Dosage Forms
CREAM

Companies

BAUSCH GRACEWAY
Active Ingredient: IMIQUIMOD

ZYCLARA Approval History

2011
2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
15 FDA actions from 2010 to 2024 · 2 indication expansions
Sep 2024 SUPPL
Label · Labeling
FDA Letter Label
Nov 2014 SUPPL
Mfg · Manufacturing (CMC)
Feb 2012 SUPPL
Mfg · Manufacturing (CMC)
FDA Letter Label

What ZYCLARA Treats

3 indications

ZYCLARA is approved for 3 conditions since its original approval in 2010. These indications span multiple therapeutic areas including oncology, immunology, and more.

  • Actinic Keratosis
  • Genital Warts
  • Perianal Warts
Source: FDA Label

ZYCLARA Competitive Set

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Three rings of competition based on shared molecular targets and treated indications.

Indication competitors

7

Same indication, different mechanism — what else might this patient receive?

KLISYRI
ALMIRALL
2020 1 indic.
AMELUZ
BIOFRONTERA
2016 1 indic.
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Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.

Drugs Similar to ZYCLARA

3 of 9

FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.

IMIQUIMOD
IMIQUIMOD
2 shared
Apotex
Shared indications:
Actinic KeratosisPerianal Warts
VEREGEN
SINECATECHINS
2 shared
ANI PHARMS
Shared indications:
Genital WartsPerianal Warts
AMELUZ
AMINOLEVULINIC ACID HYDROCHLORIDE
1 shared
BIOFRONTERA
Shared indications:
Actinic Keratosis
View all 9 similar drugs Pro
📋

Clinical Trial Registry

45 trials
Trial Sponsor ID Phase Status Title
NCT02600949 2014-1029 NCI-2016-00015, 2014-1029 Ph 1 recruiting Personalized Peptide Vaccine in Treating Patients With Advanced Pancreatic Cancer or Colorectal Cancer
NCT01795313 STUDY19100001 R01CA174858, PRO12050422 Ph 1 terminated Immunotherapy for Recurrent Ependymomas in Children Using Tumor Antigen Peptides With Imiquimod
NCT03534947 SONIB MIA2017/CT/220 HREC file number 18/087 Ph 2 completed A Study to Evaluate Neoadjuvant Sonidegib Followed by Surgery or Imiquimod in the Management of Basal Cell Carcinoma
NCT02059499 results posted AMC-088 NCI-2013-02288, AMC-088 Ph 3 completed Imiquimod, Fluorouracil, or Observation in Treating HIV-Positive Patients With High-Grade Anal Squamous Skin Lesions
NCT06356012 71163523.1.0000.5437 Ph 4 recruiting Clinical Outcome and Biomarkers for Predicting Immunological Response in Patients Treated with Imiquimod
NCT02078648 results posted STML-701-0114 Ph 1, Ph 2 completed Safety and Efficacy Study of SL-701, a Glioma-Associated Antigen Vaccine To Treat Recurrent Glioblastoma Multiforme
NCT02135419 ANCHOR results posted AMC-A01 NCI-2014-00636, AMC-A01 Ph 3 completed Treatment in Preventing Anal Cancer in Patients With HIV and Anal High-Grade Lesions
NCT01803152 20110462 Ph 1 completed Dendritic Cell Vaccine for Children and Adults With Sarcoma
NCT02394132 RADICAL 02.12 Ph 3 completed Radiotherapy or Imiquimod in Complex Lentigo Maligna
NCT00799110 07-380 Ph 2 active not recruiting Vaccination of Patients With Ovarian Cancer With Dendritic Cell/Tumor Fusions With Granulocyte Macrophage Colony-stimulating Factor (GM-CSF) and Imiquimod
NCT02864147 results posted 1603017415 000 Ph 2 completed Treatment of High-Grade Pre-Neoplastic Cervical Lesions (CIN 2/3)
NCT00788164 J0656 NA_00002176, CDR0000617261 Ph 1 completed Vaccine Therapy With or Without Imiquimod in Treating Patients With Grade 3 Cervical Intraepithelial Neoplasia
NCT02802943 iVAC-CLL01: Ph 2 completed iVAC-CLL01: Patient-individualized Peptide Vaccination After First Line Therapy of CLL
NCT01808820 20120750 Ph 1 completed Dendritic Cell (DC) Vaccine for Malignant Glioma and Glioblastoma
NCT00777127 LEIDA X-03016-3271 2007-004884-24 Ph 4 completed Long-term Effects of Imiquimod and Diclofenac in Actinic Keratoses
NCT01453179 LEIDA 2 X-03016-3284 2010-022054-16 Ph 4 completed Long-term Effects of Imiquimod and Diclofenac in Actinic Keratoses (LEIDA 2)
NCT01421017 results posted 11-00598 1R01CA161891-01 Ph 1, Ph 2 completed Toll-like Receptor (TLR) 7 Agonist, Cyclophosphamide, and Radiotherapy for Breast Cancer With Skin Metastases
NCT01861535 PITVIN KLI293 Ph 3 completed Primary Imiquimod Treatment Versus Surgery for Vulvar Intraepithelial Neoplasia
NCT03233412 BarretosCH-20171 Ph 2 completed Randomized Clinical Trial Evaluating the Efficacy of Topical Imiquimod in High Grade Cervical Intraepithelial Lesions
NCT00948428 results posted D94-3101-07 Ph 3 completed Bioequivalence of Generic Imiquimod Cream, 5% When Compared to Aldara™ (Imiquimod) Cream, 5% in the Treatment of Actinic Keratosis
NCT01400672 2009LS136 1004M81213 Ph 1 terminated Imiquimod/Brain Tumor Initiating Cell (BTIC) Vaccine in Brain Stem Glioma
NCT03472976 16-0050 HHSN272201300015I Ph 1 completed H5N1 With or Without Topical Aldara in Healthy Adults
NCT02385188 NL51648.091.14 Ph 3 completed Topical 5% Imiquimod Cream for Vulvar Paget's Disease
NCT02120898 results posted 094-3153-301 Ph 3 completed A Study to Evaluate the Safety and Efficacy Imiquimod Cream, 2.5% in Participants With Actinic Keratoses
NCT02276300 HER2 ATZ-1068-KRA-20I Ph 1 completed HER2-Peptide Vaccination of Patients With Solid Tumors
NCT02234921 DRibble 14-116B Ph 1 completed Pilot Study of DRibble Vaccine for Prostate Cancer Patients
NCT02329171 TOPIC METC 13-2-031 Ph 3 terminated Imiquimod Treatment of CIN Lesions
NCT00988559 results posted J0866 P50CA098252, 1R21CA128232 Ph 1 completed Therapeutic Vaccination for Patients With HPV16+ Cervical Intraepithelial Neoplasia (CIN2/3)
NCT00979550 results posted UK Aldara Ph 2 terminated The Effects of Aldara as an Adjunct to Laser Treatment
NCT00821964 results posted 6578 NCI-2010-00040, R01CA138521 Ph 2 completed Topical Imiquimod and Abraxane in Treating Patients With Advanced Breast Cancer
NCT01171469 2008LS053 0809M48641 Ph 1 completed Vaccination With Dendritic Cells Loaded With Brain Tumor Stem Cells for Progressive Malignant Brain Tumor
NCT01909752 UbiVac DPV-001 R44CA121612 Ph 2 completed Combination Vaccine Immunotherapy (DRibbles) for Patients With Definitively-Treated Stage III Non-small Cell Lung Cancer
NCT02130323 NMCSD.2014.0040 Ph 2, Ph 3 completed Topical Imiquimod vs. LEEP for Women With Carcinoma In-situ of the Cervix
NCT03071679 CLS001-CO-PR-015 2016-004702-34 Ph 1 completed Topical Challenge With Omiganan and Imiquimod in Healthy Volunteers
NCT01059110 VRAIE P070701 Ph 4 terminated Comparison of Five Treatments in Patients With Plantar Warts
NCT01264731 MEL53 15168 Ph 1 completed Combination Therapy of Topical Imiquimod Plus Multipeptide Vaccination for Cutaneous Metastases of Melanoma
NCT01663558 23592103 Ph 4 withdrawn Anal Dysplasia Study of Men Who Have Sex With Men Living With HIV
NCT00899574 results posted NYU 09-0225 Ph 2 completed Imiquimod for Breast Cancer Patients With Chest Wall Recurrence or Skin Metastases
NCT00941811 _1.0 ISRCTN: 2008-004893-42 Ph 2 completed Immunevasion of Human Papillomavirus (HPV) in Vulvar Intraepithelial Neoplasia 2/3 and Anogenital Warts and Efficiency and Mechanisms of Imiquimod Treatment
NCT02052687 CLFX453X2101 2013-002344-84 Ph 1 completed A First-in-human Study to Evaluate the Safety, Tolerability and Pharmacokinetics of LFX453
NCT01593124 Biomarkers D11-119 Ph 2 completed Identification of Novel Biomarkers of Cervicovaginal Mucosal Inflammation
NCT01203878 results posted 09US05N375-Gold Ph 4 terminated Treatment of Actinic Keratoses of the Face With Imiquimod 3.75% Cream Followed by Photodynamic Therapy
NCT01403285 IMA950-102 11C0192 Ph 1 terminated Peptide-based Glioma Vaccine IMA950 in Patients With Glioblastoma
NCT01161888 LIMIT-1 LIMIT-1 Ph 4 completed Effect of Topical Imiquimod on Lentigo Maligna
NCT00674739 results posted GW01-0801 Ph 3 completed Safety and Effectiveness Study of Imiquimod Creams in the Treatment of External Genital Warts
🔬

Active Pipeline

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Ongoing clinical trials by development phase

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Key Completed Trials

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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.

ZYCLARA FDA Label Details

Indications & Usage

FDA Label (PDF)

ZYCLARA is indicated for the treatment of Actinic Keratosis; Genital Warts; Perianal Warts.

View full patent landscape →
10 OB patents · 4 families · 106 international docs across 30 countries

ZYCLARA Patents & Exclusivity

Latest Patent: Apr 2030

Patents (10 active)

US11202752 Expires Apr 30, 2030
US11850245 Expires Apr 30, 2030
US10918635 Expires Apr 30, 2030
US8236816 Expires Dec 11, 2029
US8222270 Expires Dec 11, 2029
US8299109 Expires Dec 11, 2029
US11318130 Expires Dec 11, 2029
US10238644 Expires Dec 11, 2029
US10238645 Expires Aug 18, 2029
US8598196 Expires Aug 18, 2029
Source: FDA Orange Book

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Revenue Insights

  • • Quarterly revenue tracking
  • • Historical trend analysis

Patent Timeline

  • • Cliff: 2030
  • • 30 active patents

Trial Analysis

  • • Clinical trial tracking
  • • Development stage analysis

Competitive Landscape

  • • 9 similar drugs
  • • Same target/indication analysis
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Data Sources

FDA Approval: NDA022483 → Label: DailyMed → Patents: FDA Orange Book → Trials: ClinicalTrials.gov →

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