Overview
Acne vulgaris is a multifactorial disorder of the pilosebaceous unit involving increased sebum production, inflammation, and hyperproliferation/hyperkeratinization of the follicular infundibulum. It is also associated with Cutibacterium acnes (also known as Propionibacterium acnes). Adapalene is a third-generation topical retinoid used for the treatment of acne vulgaris. Adapalene has similar efficacy but a superior safety profile compared to tretinoin. Tazarotene is more efficacious than adapalene but is designated as pregnancy category X and hence is contraindicated in pregnant women. Adapalene can also be combined with benzoyl peroxide (BPO), which possesses bactericidal properties, and either adapalene alone, or adapalene BPO combination products, are commonly used to treat mild-to-severe acne. Differin®, produced by Galderma Labs, was first granted FDA approval on May 31st, 1996, as a 0.1% adapalene topical solution. Differin was later made available as 0.1% gel, cream, or lotion, or 0.3% gel products. On December 8th, 2008, Galderma Labs gained FDA approval for Epiduo®, a 0.1% adapalene, 2.5% BPO combination gel.
Background
Acne vulgaris is a multifactorial disorder of the pilosebaceous unit involving increased sebum production, inflammation, and hyperproliferation/hyperkeratinization of the follicular infundibulum. It is also associated with Cutibacterium acnes (also known as Propionibacterium acnes). Adapalene is a third-generation topical retinoid used for the treatment of acne vulgaris. Adapalene has similar efficacy but a superior safety profile compared to tretinoin. Tazarotene is more efficacious than adapalene but is designated as pregnancy category X and hence is contraindicated in pregnant women. Adapalene can also be combined with benzoyl peroxide (BPO), which possesses bactericidal properties, and either adapalene alone, or adapalene BPO combination products, are commonly used to treat mild-to-severe acne. Differin®, produced by Galderma Labs, was first granted FDA approval on May 31st, 1996, as a 0.1% adapalene topical solution. Differin was later made available as 0.1% gel, cream, or lotion, or 0.3% gel products. On December 8th, 2008, Galderma Labs gained FDA approval for Epiduo®, a 0.1% adapalene, 2.5% BPO combination gel.
Indication
Adapalene is indicated for the topical treatment of acne vulgaris in patients aged 12 and over. It is also indicated for acne vulgaris in combination with benzoyl peroxide and in a triple combination therapy with benzoyl peroxide and clindamycin.
Associated Conditions
- Acne Vulgaris
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2025/06/11 | Phase 1 | Completed | |||
2025/06/11 | Phase 4 | Recruiting | |||
2025/01/15 | Phase 3 | Not yet recruiting | Dr.dr.Irma Bernadette, SpKK (K) | ||
2023/11/21 | Not Applicable | Recruiting | HITEC-Institute of Medical Sciences | ||
2023/06/12 | Phase 2 | Not yet recruiting | |||
2022/10/17 | Early Phase 1 | Recruiting | |||
2022/09/13 | Phase 3 | Withdrawn | |||
2022/08/11 | Phase 1 | Active, not recruiting | Dr.dr.Irma Bernadette, SpKK (K) | ||
2021/10/27 | Phase 4 | Completed | East Avenue Medical Center, Philippines | ||
2021/04/01 | Early Phase 1 | Withdrawn |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| PruGen, Inc. | 42546-720 | TOPICAL | 45 g in 1 g | 1/24/2018 | |
| Physicians Total Care, Inc. | 54868-5271 | TOPICAL | 1 mg in 1 g | 1/21/2011 | |
| Galderma Laboratories, L.P. | 0299-5912 | TOPICAL | 0.1 g in 100 mL | 4/20/2023 | |
| Galderma Laboratories, L.P. | 0299-5908 | TOPICAL | 1 mg in 1 g | 2/19/2018 | |
| Zydus Lifesciences Limited | 70771-1716 | TOPICAL | 3 mg in 1 g | 6/6/2022 | |
| Galderma Laboratories, L.P. | 0299-5906 | TOPICAL | 3 mg in 1 g | 4/27/2022 | |
| A-S Medication Solutions | 50090-2004 | TOPICAL | 1 mg in 1 g | 8/25/2021 | |
| E. Fougera & Co. a division of Fougera Pharmaceuticals Inc. | 0168-0424 | TOPICAL | 1 mg in 1 g | 8/22/2018 | |
| Sincerus Florida, LLC | 72934-1002 | TOPICAL | 0.1 g in 100 g | 6/3/2020 | |
| Taro Pharmaceuticals U.S.A., Inc. | 51672-1384 | TOPICAL | 3 mg in 1 g | 12/27/2022 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
| No EMA approvals found for this drug. | |||
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| DIFFERIN GEL 0.1% | SIN08957P | GEL | 0.1% w/w | 10/7/1996 | |
| DIFACLEAR GEL 0.1%w/w | SIN15136P | GEL | 1.00mg/g | 12/13/2016 | |
| DIFFERIN CREAM 0.1% | SIN11116P | CREAM | 0.1% | 9/16/1999 | |
| EPIDUO FORTE GEL 0.3%/2.5% | SIN15460P | GEL | 0.30 %W/W | 4/3/2018 | |
| EPIDUO GEL 0.1%/2.5% | SIN13789P | GEL | 0.10% | 4/21/2010 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| Adapalene Gel | 国药准字H20064230 | 化学药品 | 凝胶剂 | 7/14/2020 | |
| Adapalene Gel | 国药准字H20183078 | 化学药品 | 凝胶剂 | 3/7/2023 | |
| Adapalene Gel | 国药准字HJ20160022 | 化学药品 | 凝胶剂 | 9/18/2020 | |
| Adapalene Gel | 国药准字H20056871 | 化学药品 | 凝胶剂 | 10/8/2020 | |
| Adapalene Gel | 国药准字H20083655 | 化学药品 | 凝胶剂 | 3/2/2023 | |
| Adapalene Gel | 国药准字H20249038 | 化学药品 | 凝胶剂 | 10/9/2024 | |
| Adapalene Gel | 国药准字H20065544 | 化学药品 | 凝胶剂 | 7/30/2021 | |
| Adapalene Gel | 国药准字H20183400 | 化学药品 | 凝胶剂 | 4/28/2023 | |
| Adapalene Gel | 国药准字H20066621 | 化学药品 | 凝胶剂 | 3/12/2021 | |
| Adapalene Gel | 国药准字H20173406 | 化学药品 | 凝胶剂 | 11/15/2022 |
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| No PPB approvals found for this drug. | |||||
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| EPIDUO adapalene / benzoyl peroxide 0.1%/2.5% gel tube | 143869 | Medicine | A | 1/22/2009 | |
| DIFFERIN adapalene 1mg/g cream tube | 66174 | Medicine | A | 9/22/1998 | |
| EPIDUO FORTE adapalene/benzoyl peroxide 0.3%/2.5% gel bottle | 273168 | Medicine | A | 3/10/2017 | |
| EPIDUO 0.1%/2.5% adapalene / benzoyl peroxide gel bottle | 222977 | Medicine | A | 8/7/2014 | |
| ADAPAX 0.1%/0.25% adapalene/benzoyl peroxide 0.1%/2.5% gel bottle | 427930 | Medicine | A | 3/31/2025 | |
| DIFFERIN adapalene 1mg/g gel tube | 53918 | Medicine | A | 11/29/1995 | |
| NOVADUO 0.1%/0.25% adapalene/benzoyl peroxide 0.1%/2.5% gel bottle | 427929 | Medicine | A | 3/31/2025 | |
| EPIDUO FORTE adapalene/benzoyl peroxide 0.3%/2.5% gel tube | 273181 | Medicine | A | 3/10/2017 | |
| DIFFERIN ACNE TREATMENT adapalene 1 mg/g cream tube | 404329 | Medicine | A | 2/3/2023 | |
| DIFFERIN ACNE TREATMENT adapalene 1 mg/g gel tube | 404112 | Medicine | A | 1/31/2023 |