Drugs / Adapalene

Regulatory milestones approvals, filings & regulatory actions · 2 recorded

MilestoneJurisdictionBrandIndicationDateSentence it was read from
Label expansion US (FDA) DIFFERIN — 2016-07-08 fda.gov ↗
Approved US (FDA) DIFFERIN — 1996-05-31 fda.gov ↗

Trials 50

PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 04 trials
Phase 0 NCT07673094 Aug 2026 → Feb 2027 expected acne Khyber Teaching Hospital Not yet recruiting No outcome recorded
Phase 0 NCT05582434 Feb 2024 → Jun 2025 overdue acne Wake Forest University Health Sciences Active not recruiting No outcome recorded
Phase 0 NCT04823845 May → Dec 2022 plantar wart University of Louisville Withdrawn No outcome recorded
Phase 0 NCT04797793 May 2020 → Jan 2021 acne Sun Pharmaceutical Industries, Inc. Completed No outcome recorded
Phase 16 trials
Phase 1 NCT06673641 May → Sep 2024 acne Sun Pharmaceutical Industries, Inc. Completed No outcome recorded
Phase 1 NCT05497323 Aug → Nov 2022 acne Indonesia University Unknown No outcome recorded
Phase 1 NCT03653403 Aug 2018 → Jun 2019 acne Bausch Health Americas, Inc. Completed No outcome recorded
Phase 1 NCT02709902 Sep 2015 → Feb 2016 acne Sun Pharmaceutical Industries, Inc. Completed No outcome recorded
Phase 1 NCT02411942 Aug 2014 → Feb 2015 acne Sun Pharmaceutical Industries, Inc. Completed No outcome recorded
Phase 1 NCT01742637 Oct 2012 → Feb 2014 acne Sun Pharmaceutical Industries, Inc. Completed No outcome recorded
Phase 1/23 trials
Phase 1/2 NCT07015931 Nov 2024 → Mar 2025 acne Indonesia University Completed No outcome recorded
Phase 1/2 NCT03076320 Mar 2017 → Jan 2019 acne University of Guadalajara Completed No outcome recorded
Phase 1/2 NCT02593383 Mar 2015 → Jul 2017 acne Lee's Pharmaceutical Limited Completed No outcome recorded
Phase 23 trials
Phase 2 NCT04892706 Jun 2021 → Sep 2022 acne Bausch Health Americas, Inc. Completed No outcome recorded
Phase 2 NCT01213199 Mar 2011 → Apr 2012 acne Galderma R&D Completed No outcome recorded
Phase 2 NCT01245946 Oct 2010 → May 2011 acne Pontificia Universidad Catolica de Chile Completed No outcome recorded
Phase 312 trials · 2 met primary
Phase 3 NCT02932267 Feb 2017 → Jan 2018 acne Galderma R&D Completed No outcome recorded
Phase 3 NCT02651220 Nov 2015 → Apr 2016 acne Actavis Inc. Completed Met primary
Phase 3 NCT01910064 May 2013 → Aug 2014 acne Galderma R&D Completed No outcome recorded
Phase 3 NCT01474590 Nov 2011 → Jul 2013 acne Galderma R&D Completed Met primary
Phase 3 NCT00687908 Nov 2008 → Jul 2009 acne Galderma R&D Completed No outcome recorded
Phase 3 NCT00688064 Aug 2008 → Feb 2009 acne Galderma R&D Completed No outcome recorded
Phase 3 NCT00599521 Nov 2007 → Nov 2008 acne Galderma R&D Completed No outcome recorded
Phase 3 NCT00598832 Nov 2007 → Oct 2008 acne Galderma R&D Completed No outcome recorded
Phase 3 NCT00441415 Feb → Oct 2007 acne Galderma R&D Completed No outcome recorded
Phase 3 NCT00422240 Jun 2006 → Jul 2007 acne Galderma R&D Completed No outcome recorded
Phase 418 trials · 1 met primary
Phase 4 NCT07016360 Sep 2025 → Feb 2026 overdue plantar wart Khyber Teaching Hospital Recruiting No outcome recorded
Phase 4 NCT07102186 Jul → Oct 2025 overdue acne Badr University Recruiting No outcome recorded
Phase 4 NCT06336603 Nov 2023 → Oct 2024 acne Sun Pharmaceutical Industries, Inc. Completed No outcome recorded
Phase 4 NCT03563365 Jun 2018 → Mar 2021 acne Yardley Dermatology Associates Terminated No outcome recorded Stop: Business
Phase 4 NCT03626298 Aug → Dec 2016 acne Rumah Sakit Pusat Angkatan Darat Gatot Soebroto Completed No outcome recorded
Phase 4 NCT02899000 Jul 2016 → Mar 2017 acne Galderma R&D Completed No outcome recorded
Phase 4 NCT02735421 May 2016 → Jun 2017 acne Galderma R&D Completed Met primary
Phase 4 NCT01951417 Oct 2013 → Mar 2014 acne Galderma R&D Completed No outcome recorded
Phase 4 NCT01504204 Dec 2011 → Nov 2012 acne Wake Forest University Completed No outcome recorded
Phase 4 NCT01209949 Oct 2010 → Jan 2011 acne Galderma R&D Completed No outcome recorded
Phase not applicable4 trials
— NCT07348978 Nov 2024 → Jun 2025 acne University of Medicine and Pharmacy at Ho Chi Minh City Completed No outcome recorded
— NCT05855629 Feb 2022 → Jun 2023 acne Treatment and Diagnostic Center of Private Enterprise "Asklepiy" Unknown No outcome recorded
— NCT03573115 Jan → Jul 2018 acne Merete Haedersdal Completed No outcome recorded
— NCT01095640 Mar → Dec 2009 acne Actavis Mid-Atlantic LLC Completed No outcome recorded
Comparator or background therapy44 trials
Phase 1 NCT01425320 Comparator Jan → Jun 2013 acne Allergan Withdrawn No outcome recorded Stop: Enrollment
Phase 1 NCT01046396 Comparator Jan → Feb 2010 skin disorder Galderma R&D Completed No outcome recorded
Phase 1 NCT01046565 Comparator Jan → Feb 2010 skin disorder Galderma R&D Completed No outcome recorded
Phase 1 NCT00719121 Comparator Nov → Dec 2006 dermatitis Stiefel, a GSK Company Completed No outcome recorded
Phase 2 NCT07473895 Comparator Apr → Oct 2026 expected acne Assiut University Not yet recruiting No outcome recorded

News releases announcing trial results or a regulatory action · 12

DateIssuerRelease
2026-05-22 Galderma R&D Regulatory Galderma receives U.S. FDA approval for Differin® Epiduo® Acne Gel Prescription-to-OTC switch galderma.com ↗
Adapalene plus benzoyl peroxide (0.1/2.5%) was the first FDA-approved, stable, fixed- dose prescription acne treatment to combine of benzoyl peroxide with a retinoid, and is now available over-the-counter
2024-03-06 AbbVie Results AbbVie and Allergan Aesthetics to Present New Data at 2024 Annual AAD Meeting Showcasing Depth and Strength Across Dermatology and Aesthetics Portfolios abbvie.com ↗
Comparable Efficacy and Less Dryness With a Novel Cosmetic Regimen When Compared to a Topical Drug Combination of Adapalene 0.1% and Benzoyl Peroxide 2.5% in Subjects With Mild to Moderate Facial Acne
2020-06-01 Alembic Pharmaceuticals Ltd. Regulatory 19th June, 2020, Vadodara, India alembicpharmaceuticals.com ↗
Alembic Pharmaceuticals Limited (Alembic) today announced that its joint venture Aleor Dermaceuticals Limited (Aleor) has received approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Adapalene Gel USP, 0.3%.
2018-05-07 Galderma R&D Results Galderma Announces Results of ALAMO: A Real-World, Phase 4 Study Demonstrating Efficacy and Safety of Epiduo® Forte (adapalene and benzoyl peroxide) Gel, 0.3%/2.5% Plus Oral Doxycycline 200 mg in Treating Severe Inflammatory Acne galderma.com ↗
In this study, the primary efficacy endpoint of reduction in number of inflammatory lesions at the end of the 12-week treatment period was met.
2018-04-30 Galderma R&D Results New Phase 4 OSCAR Trial Data Showed that Epiduo® Forte (adapalene and benzoyl peroxide) Gel, 0.3%/2.5% Decreased Acne Lesions Therefore Reducing the Risk of Scars in Moderate-to-Severe Acne Patients galderma.com ↗
Results demonstrated Epiduo Forte Gel significantly decreased acne lesions, as measured over a period of 24 weeks vs. vehicle (P < .0001), with acne lesion reduction as early as week one.
2016-09-27 Galderma R&D Regulatory Galderma receives Positive Opinion through European Decentralised Procedure for Approval of EPIDUO® 0.3% / 2.5% gel for Acne Patient galderma.com ↗
it has received a Positive Opinion from 16 concerned European regulatory agencies for the market approval of EPIDUO 0.3% / 2.5% gel
2016-07-15 Galderma R&D Regulatory FDA Approves Galderma’s prescription-strength Differin Gel for over-the-counter use in treatment of acne in the U.S. galderma.com ↗
Galderma, Nestlé Skin Health’s medical solutions business, announced that the U.S. Food and Drug Administration (FDA) has approved Differin Gel (adapalene gel 0.1%) as an over-the-counter (OTC) treatment for acne.
2012-03-06 Galderma R&D Regulatory Galderma receives FDA Approval for new convenient Pump Dispenser of Differin Gel, 0.3% for treatment of Acne Vulgaris galderma.com ↗
Galderma Laboratories, L.P. received approval from the U.S. Food and Drug Administration (FDA) for a pump dispenser for Differin (adapalene) Gel, 0.3%, a retinoid indicated for the topical treatment of acne vulgaris in patients 12 years and older.
2010-06-02 Teva Branded Pharmaceutical Products R&D, Inc. Regulatory Teva Announces Launch of Generic Differin® tevapharm.com ↗
Teva Pharmaceutical Industries Ltd. (Nasdaq:TEVA) today announced U.S. Food and Drug Administration (FDA) approval and commercial launch of its generic version of Galderma's product, Differin® (adapalene 0.1%) Gel, which is indicated for the treatment of acne.
2010-03-22 Galderma R&D Regulatory Galderma Received FDA Approval of Differin® (adapalene) Lotion, 0.1%, the First Retinoid Available in Lotion Formulation galderma.com ↗
Fort Worth, TX – March 22, 2010 – Galderma Laboratories, L.P. today announced the U.S. Food and Drug Administration (FDA) approval of Differin® (adapalene) Lotion, 0.1%, the first-ever lotion formulation of the well-tolerated retinoid adapalene, for the treatment of acne.
2008-07-16 Galderma R&D Regulatory Galderma announces Approval for Differin ® Gel 0.1% in Japan galderma.com ↗
Galderma Pharma S.A., a global specialty pharmaceutical company focused on dermatology, announced today that Japan’s Ministry of Health, Labor and Welfare has approved Differin ® Gel 0.1% (adapalene), a novel topical treatment for acne vulgaris in Japan.
2007-06-20 Galderma R&D Regulatory FDA approves Differin (adapalene) Gel, 0.3% for acne galderma.com ↗
Galderma Laboratories, L.P., announced today that the U.S. Food and Drug Administration (FDA) has approved Differin ® (adapalene) Gel, 0.3%, a new, higher concentration formulation of Differin ® (adapalene) 0.1%, a topical retinoid indicated for the treatment of acne.

All press releases naming this drug 24 releases

DateIssuerRelease

Evidence & citations 16 cited values

Every value below carries the sentence it was read from. 97 sources stand behind the page.

FieldValueCited text
Known as adapalene “Participants with moderate and severe acne will be treated once a day (at night) on the face and superior back with a smooth layer (standard finger tip unit 0.5 g for an area...” NCT03076320 ↗
94

“To evaluate the safety and plasma pharmacokinetics (PK) of clindamycin and adapalene in IDP-126 Gel compared with that from Control Gel in subjects with moderate to severe acne...” NCT03653403 ↗

“Participants applied Adapalene 0.3% - Benzoyl peroxide (BPO) 2.5% gel (ABPO Forte) topically to the affected areas once daily for 24 weeks in Part 1 and for 48 weeks in Part 2.” NCT02735421 ↗

“Clindamycin phosphate (CLIN) 1.2%/adapalene (ADAP) 0.15%/benzoyl peroxide (BPO) 3.1% gel (CAB) is the only triple-combination topical approved for acne.” PMID 40377868 ↗ May 2025

“Differin gel, containing adapalene 0.1%, has been used now for several years in the topical treatment of mild to moderate acne.” NCT01387048 ↗

“topical tretinoin or adapalene once daily (every other day if irritation) with doxycycline or lymecycline 100 mg/d” NCT06447480 ↗

“Conventional therapy: Topical adapalene gel 0.1% at night for 12 weeks plus doxycycline 100 mg / day for 6 weeks.” NCT01245946 ↗

“Once-daily application of fixed dose of adapalene 0.1% and benzoyl peroxide 2.5% in an aqueous based gel.” NCT01522456 ↗

“fixed-combination adapalene plus benzoyl peroxide (A/BPO) is a first-line recommended acne therapy” PMID 28686776 ↗ Jun 2017

“fixed dose combination of 0.3% adapalene with 2.5% benzoyl peroxide (A/BPO gel 0.3%/2.5%)” PMID 28686775 ↗ Jun 2017

“GK530G is the fixed-dose combination gel of Adapalene and Benzoyl Peroxide, BPO” NCT01910064 ↗

Show 84 more sources

Known as ADA “ADA 0.1% gel containing 0.1% of adapalene.” NCT02557399 ↗
Known as ADAP “Clindamycin phosphate (CLIN) 1.2%/adapalene (ADAP) 0.15%/benzoyl peroxide (BPO) 3.1% gel (CAB) is the only triple-combination topical approved for acne.” PMID 40377868 ↗ May 2025
Known as Adapalene component of cabtreo ChEMBL registry synonym — accepted as the source's own label CHEMBL1265 ↗
Known as Adapalene component of epiduo ChEMBL registry synonym — accepted as the source's own label CHEMBL1265 ↗
Known as Adapalene component of idp-126 ChEMBL registry synonym — accepted as the source's own label CHEMBL1265 ↗
Known as adapalene gel 0.1% “Dapsone Topical Gel + adapalene gel 0.1%” NCT00151541 ↗
Known as Adapaleno ChEMBL registry synonym — accepted as the source's own label CHEMBL1265 ↗
Known as CD 271 ChEMBL registry synonym — accepted as the source's own label CHEMBL1265 ↗
Known as Differin “Marketed by Galderma Laboratories, L.P., Differin® (adapalene 0.3% topical gel) is a safe and effective topical therapy used for the treatment of acne vulgaris.” NCT01095640 ↗
3

“Differin gel, containing adapalene 0.1%, has been used now for several years in the topical treatment of mild to moderate acne.” NCT01387048 ↗

“Differin® (adapalene gel 0.3%) (Galderma Laboratories, LP, US)” NCT02411942 ↗

“Differin™, 0.1% adapalene gel” NCT00719121 ↗

Known as Differin Gel “A Pharmacokinetic Study to Compare the Systemic Exposure to Adapalene During Dermal Application of Either Differin® Gel, 0.3% (Adapalene 0.3%) or Differin® Gel, 0.1% (Adapalene...” NCT00660985 ↗
2

“Differin® Gel (a Gel Containing 0.1% Adapalene)” NCT00160394 ↗

“Differin® Gel (Adapalene 0.1%, Galderma)” NCT04797793 ↗

Known as Differine “adapalene cream (Differine®)” NCT06447480 ↗
Known as Product A “Product A (adapalene)” NCT02755545 ↗
Action Inhibit “the fixed-dose combination gel containing adapalene 0.1% and benzoyl peroxide 2.5% effectively inhibited both antibiotic-susceptible and antibiotic-resistant Propionibacterium acnes.” PMID 21607190 ↗ May 2011
Modality Other / unclassified “A gel combination treatment containing a retinoid (adapalene 0.1%)” PMID 21607190 ↗ May 2011
Route Topical “Dapsone Topical Gel + adapalene gel 0.1%” NCT00151541 ↗