Drugs / Adapalene
Adapalene
also known as
Differin · Differin Gel · ADA · ADAP · Adapalene component of cabtreo · Adapalene component of epiduo · Adapalene component of idp-126 · adapalene gel 0.1% · +4 more
Regulatory milestones approvals, filings & regulatory actions · 2 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence 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 · a red edge is where a trial was stopped
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| 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| Phase 0 | NCT04823845 | May → Dec 2022 | plantar wart | University of Louisville | Withdrawn | No outcome recorded |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 | ||||||
| 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 | No outcome recorded |
| 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 | No outcome recorded |
| 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 | NCT00598832 | Nov 2007 → Oct 2008 | 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 | 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 3 | NCT00151541 | Feb → Jul 2005 | acne | Allergan | Completed | No outcome recorded |
| Phase 3 | NCT00446043 | Feb 2004 → May 2005 | acne | Galderma R&D | Completed | No outcome recorded |
| Phase 418 trials | ||||||
| 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 |
| 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 | No outcome recorded |
| 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 4 | NCT01149330 | Jul 2010 → Mar 2011 | acne | Galderma Brasil Ltda. | Completed | No outcome recorded |
| Phase 4 | NCT01188538 | Mar → Aug 2010 | acne | Galderma R&D | Completed | No outcome recorded |
| Phase 4 | NCT00952523 | Jul → Oct 2009 | acne | Bausch Health Americas, Inc. | Completed | No outcome recorded |
| Phase 4 | NCT00907101 | Jun → Jul 2009 | — | Galderma R&D | Completed | No outcome recorded |
| Phase 4 | NCT00919191 | Apr → May 2009 | acne | Bausch Health Americas, Inc. | Completed | No outcome recorded |
| Phase 4 | NCT00714714 | Jan → Feb 2008 | acne | Bausch Health Americas, Inc. | Completed | No outcome recorded |
| Phase 4 | NCT00671749 | Dec 2007 → Aug 2008 | acne | Galderma R&D | Completed | No outcome recorded |
| Phase 4 | NCT00160394 | Dec 2004 → Aug 2005 | acne | Stiefel, a GSK Company | 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 |
Also used as a comparator or background therapy in 43 trials
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 14 trials | ||||||
| Phase 1 | NCT01425320 Comparator | Jan → Jun 2013 | acne | Allergan | Withdrawn | No outcome recorded |
| Phase 1 | NCT01046565 Comparator | Jan → Feb 2010 | skin disorder | Galderma R&D | Completed | No outcome recorded |
| Phase 1 | NCT01046396 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 25 trials | ||||||
| Phase 2 | NCT07473895 Comparator | Apr → Oct 2026 expected | acne | Assiut University | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT05899699 Comparator | Jun → Sep 2023 | acne | Mansoura University | Unknown | No outcome recorded |
| Phase 2 | NCT04104685 Comparator | Sep 2019 → Feb 2020 | acne | Vyne Therapeutics Inc. | Completed | No outcome recorded |
| Phase 2 | NCT01485367 Comparator | Dec 2011 → Dec 2012 | purpura | Multispecialty Aesthetic Clinical Research Organization | Unknown | No outcome recorded |
| Phase 2 | NCT01106807 Comparator | Apr → Sep 2010 | acne | Galderma R&D | Completed | No outcome recorded |
| Phase 312 trials | ||||||
| Phase 3 | NCT06447480 Comparator | Apr 2025 → Sep 2026 expected | acne | Centre Hospitalier Universitaire de Nice | Recruiting | No outcome recorded |
| Phase 3 | NCT06775314 Comparator | Mar → May 2025 overdue | acne | Indonesia University | Not yet recruiting | No outcome recorded |
| Phase 3 | NCT05536882 Comparator | May 2022 → Oct 2023 | molluscum contagiosum | University of Oklahoma | Withdrawn | No outcome recorded |
| Phase 3 | NCT03615768 Comparator | Aug 2018 → Feb 2020 | acne | Lee's Pharmaceutical Limited | Completed | No outcome recorded |
| Phase 3 | NCT06451237 Comparator | Jan 2018 → Dec 2022 | acne | Alexandria University | Completed | No outcome recorded |
| Phase 3 | NCT01880320 Comparator | Jul 2013 → Mar 2014 | acne | Galderma R&D | Completed | No outcome recorded |
| Phase 3 | NCT01406080 Comparator | Jan 2013 → Nov 2015 | hyperpigmentation of the skin, radiation-induced disorder | Galderma Brasil Ltda. | Completed | No outcome recorded |
| Phase 3 | NCT01014689 Comparator | Aug 2009 → Apr 2010 | acne | Galderma R&D | Completed | No outcome recorded |
| Phase 3 | NCT00883233 Comparator | Apr → Sep 2009 | acne | Galderma R&D | Completed | No outcome recorded |
| Phase 3 | NCT00647556 Comparator | Apr 2008 → Jan 2010 | hyperpigmentation of the skin | Galderma R&D | Completed | No outcome recorded |
| Phase 3 | NCT00421993 Comparator | Oct 2006 → Oct 2007 | acne | Galderma R&D | Completed | No outcome recorded |
| Phase 3 | NCT02716090 Background | ? → Nov 2015 | acne | Ache Laboratorios Farmaceuticos S.A. | Withdrawn | No outcome recorded |
| Phase 418 trials | ||||||
| Phase 4 | NCT03866447 Comparator | Oct 2019 → Nov 2020 | acne | Assiut University | Unknown | No outcome recorded |
| Phase 4 | NCT03832647 Background | Feb 2019 → Feb 2020 | acne | Vichy Laboratoires | Completed | No outcome recorded |
| Phase 4 | NCT05096312 Comparator | Dec 2018 → Jul 2019 | acne | East Avenue Medical Center, Philippines | Completed | No outcome recorded |
| Phase 4 | NCT02755545 Comparator | May 2016 → Apr 2017 | acne | Galderma R&D | Completed | No outcome recorded |
| Phase 4 | NCT02721173 Comparator | Apr → Dec 2016 | acne | All India Institute of Medical Sciences, Bhubaneswar | Completed | No outcome recorded |
| Phase 4 | NCT02557399 Comparator | Oct → Dec 2015 | acne | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 4 | NCT01522456 Comparator | Apr → May 2012 | acne | Galderma R&D | Completed | No outcome recorded |
| Phase 4 | NCT01387048 Comparator | Aug 2011 → Aug 2012 | acne | University of Magdeburg | Completed | No outcome recorded |
| Phase 4 | NCT01231334 Comparator | Aug 2010 → Jun 2011 | acne | Allergan | Completed | No outcome recorded |
| Phase 4 | NCT01138735 Comparator | Jun 2010 → Aug 2011 | acne | Galderma R&D | Completed | No outcome recorded |
| Phase 4 | NCT00964223 Comparator | Jul → Nov 2009 | acne | Stiefel, a GSK Company | Completed | No outcome recorded |
| Phase 4 | NCT00926367 Comparator | May → Jun 2009 | acne | Stiefel, a GSK Company | Completed | No outcome recorded |
| Phase 4 | NCT00887484 Comparator | Feb → Jun 2009 | acne | Stiefel, a GSK Company | Completed | No outcome recorded |
| Phase 4 | NCT00660985 Comparator | May → Aug 2008 | acne | Galderma R&D | Completed | No outcome recorded |
| Phase 4 | NCT00829049 Comparator | Oct 2007 → Oct 2008 | acne | Allergan | Terminated | No outcome recorded |
| Phase 4 | NCT00807014 Comparator | Nov 2006 → Aug 2008 | acne | Stiefel, a GSK Company | Completed | No outcome recorded |
| Phase 4 | NCT00696449 Background | Jun 2006 → May 2007 | acne | Wake Forest University | Completed | No outcome recorded |
| Phase 4 | NCT00469755 Comparator | Feb → Sep 2006 | acne | Galderma R&D | Completed | No outcome recorded |
| Phase not applicable4 trials | ||||||
| — | NCT06141330 Background | Feb 2024 → Feb 2025 | acne | HITEC-Institute of Medical Sciences | Completed | No outcome recorded |
| — | NCT07237763 Comparator | Jan 2024 → Dec 2025 overdue | acne | Cairo University | Active not recruiting | No outcome recorded |
| — | NCT03650881 Comparator | Aug 2018 → Feb 2020 | acne | NYU Langone Health | Withdrawn | No outcome recorded |
| — | NCT03585140 Background | Jan → May 2016 | acne | Centro Dermatológico Dr. Ladislao de la Pascua | Completed | No outcome recorded |
Press releases naming this drug 1 release
| Date | Issuer | Release |
|---|---|---|
| 2010-06-02 | Teva Branded Pharmaceutical Products R&D, Inc. | Teva Announces Launch of Generic Differin® tevapharm.com ↗ |
Evidence & citations 16 cited values
Every value below carries the sentence it was read from. 96 sources stand behind the page.
| Field | Value | Cited 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 ↗93“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 ↗ “fixed-dose adapalene/benzoyl peroxide plus doxycycline vs. oral isotretinoin” PMID 24934963 ↗ Oct 2014 “Dose or Concentration:Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel.” NCT01188538 ↗ “Differin® Gel (gel with 0.1% adapalene), used once daily” NCT00807014 ↗ “ADA 0.1% gel containing 0.1% of adapalene.” NCT02557399 ↗ “gel containing 0.1% adapalene once daily” NCT00160394 ↗ “100 per arm Adapalene/ Benzoyl Peroxide” NCT03832647 ↗ “Product A (adapalene)” NCT02755545 ↗ “0.3% Adapalene Foam” NCT04104685 ↗ “adapalene gel” NCT06451237 ↗ |
| 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 ↗ |