> Trialight public data. Index of pages: https://trialight.com/llms.txt
> Web page: https://trialight.com/data/asset/adapalene-3faa801e-ff34-482b-86c4-5ca9ef98b2b7
> Record changed: 2026-10-13

# Adapalene

Highest phase reached

Approved

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1265)

Drug type

Small molecule

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1265)

First approval year

1996

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1265)

## Development status

**First approval year**

1996

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1265)

**Listing at source**

Listed

**Highest phase reached**

Approved

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1265)

## Names and chemistry

**Drug type**

Small molecule

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1265)

**Drug name**

Adapalene

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1265)

**Molecular weight**

412.53

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1265)

**Structure (SMILES)**

COc1ccc(-c2ccc3cc(C(=O)O)ccc3c2)cc1C12CC3CC(CC(C3)C1)C2

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1265)

### Brand names (10)

- adapalene
- Adapalene
- adapalene component of cabtreo
- Adapalene component of cabtreo
- adapalene component of epiduo
- Adapalene component of epiduo
- adapalene component of idp 126
- Adapalene component of idp-126
- differin
- Differin

### Other names (40)

- ada adapalene
- adapalene
- Adapalene
- Adapalene \[EP MONOGRAPH\]
- adapalene \[INN\]
- Adapalene \[JAN\]
- Adapalene \[MART.\]
- Adapalene \[MI\]
- Adapalene \[ORANGE BOOK\]
- Adapalene \[USAN\]
- ADAPALENE \[USP MONOGRAPH\]
- ADAPALENE \[USP-RS\]
- ADAPALENE \[VANDF\]
- Adapalene \[WHO-DD\]
- adapalene ep monograph
- adapalene inn
- adapalene jan
- adapalene mart
- adapalene mi
- adapalene orange book
- adapalene usan
- adapalene usp monograph
- adapalene usp rs
- adapalene vandf
- adapalene who dd

And 15 more, listed on the interactive page.

## Identifiers

**CAS registry numbers**

- 106685-40-9

**ChEMBL ID**

CHEMBL1265

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1265)

**InChIKey**

LZCDAPDGXCYOEH-UHFFFAOYSA-N

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1265)

**PubChem compound IDs**

- 60164

**RxNorm IDs (RxCUI)**

- 60223

**FDA ingredient codes (UNII)**

- 1L4806J2QF

### ATC classification codes (2)

- D10AD03
- D10AD53

Sources for recorded values

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1265)

## Regulatory information

### United States

**Applicant**

GALDERMA LABS LP

**Approval date**

31 May 1996

**Application number**

NDA020380

### Other regulatory facts

**Patents**

3

**Designations**

0

**Earliest recorded loss of exclusivity**

31 May 2028

**First in class**

No

**Fast track**

No

**Breakthrough designation**

No

**Orphan designation**

No

**Priority review**

No

**Orphan exclusivity**

No

**Accelerated approval**

No

**Availability**

Over the counter

## Pharmacology

### Drug classification

**Pharmacology name**

adapalene

**Type**

Synthetic organic

**Approval recorded by Guide to Pharmacology**

Yes

#### Administration routes

- topical

### Mechanisms of action (6)

- **Action**  
Agonist

**Action type**  
Agonist

**Target**  
Retinoic acid receptor-α

**Gene symbol**  
RARA

**Protein identifier**  
P10276

**Median affinity**

5.96

**Affinity units**  
pKi
- **Action**  
Agonist

**Action type**  
Agonist

**Target**  
Retinoic acid receptor-β

**Gene symbol**  
RARB

**Protein identifier**  
P10826

**Median affinity**

7.47

**Affinity units**  
pKi

**Primary target**  
Yes
- **Action**  
Agonist

**Action type**  
Agonist

**Target**  
Retinoic acid receptor-γ

**Gene symbol**  
RARG

**Protein identifier**  
P13631

**Median affinity**

6.89

**Affinity units**  
pKi

**Primary target**  
Yes
- **Mechanism**  
Retinoic acid receptor agonist

**Action type**  
Agonist

**Target**  
Retinoic acid receptor

**Protein identifier**  
P10276
- **Mechanism**  
Retinoic acid receptor agonist

**Action type**  
Agonist

**Target**  
Retinoic acid receptor

**Protein identifier**  
P10826
- **Mechanism**  
Retinoic acid receptor agonist

**Action type**  
Agonist

**Target**  
Retinoic acid receptor

**Protein identifier**  
P13631

### Open Targets mechanisms

- **Mechanism**  
Retinoic acid receptor agonist

**Action type**  
Agonist

**Target**  
Retinoic acid receptor

### DrugCentral mechanisms (2)

- **Action type**  
Agonist

**Gene symbol**  
RARB

**Protein identifier**  
P10826

**Organism**  
Homo sapiens

**Target development level**  
Clinical
- **Action type**  
Agonist

**Gene symbol**  
RARG

**Protein identifier**  
P13631

**Organism**  
Homo sapiens

**Target development level**  
Clinical

### Investigated indications (3)

- **Condition**  
Skin Diseases

**Highest recorded phase**  
1

**Condition identifier**  
EFO:0000701

**Subject identifier**  
D012871
- **Condition**  
Acne Vulgaris

**Highest recorded phase**  
4

**Condition identifier**  
EFO:0003894

**Subject identifier**  
D000152
- **Condition**  
Molluscum Contagiosum

**Highest recorded phase**  
3

**Condition identifier**  
EFO:0007375

**Subject identifier**  
D008976

### Open Targets indications (8)

- **Condition identifier**  
EFO\_0000701

**Highest recorded phase**  
1
- **Condition identifier**  
EFO\_0003894
- **Condition identifier**  
EFO\_0007375

**Highest recorded phase**  
3
- **Condition identifier**  
EFO\_1002023
- **Condition identifier**  
MONDO\_0001795

**Highest recorded phase**  
1
- **Condition identifier**  
MONDO\_0005855

**Highest recorded phase**  
3
- **Condition identifier**  
MONDO\_0011438

**Highest recorded phase**  
4
- **Condition identifier**  
MP\_0001845

**Highest recorded phase**  
1

### Reported adverse events (77)

- **Event**  
abdominal pain

**Reports**  
1

**Reporting signal score**

10.5624
- **Event**  
acne

**Reports**  
164

**Reporting signal score**

628.582
- **Event**  
acne cystic

**Reports**  
13

**Reporting signal score**

57.3752
- **Event**  
acne pustular

**Reports**  
2

**Reporting signal score**

6.89649
- **Event**  
acute kidney injury

**Reports**  
1

**Reporting signal score**

6.80755
- **Event**  
application site burn

**Reports**  
6

**Reporting signal score**

16.8731
- **Event**  
application site dryness

**Reports**  
3

**Reporting signal score**

9.86573
- **Event**  
application site erythema

**Reports**  
11

**Reporting signal score**

21.5942
- **Event**  
application site exfoliation

**Reports**  
6

**Reporting signal score**

21.4366
- **Event**  
application site pruritus

**Reports**  
9

**Reporting signal score**

18.8253
- **Event**  
application site rash

**Reports**  
5

**Reporting signal score**

8.991
- **Event**  
application site swelling

**Reports**  
4

**Reporting signal score**

10.4505
- **Event**  
asthenia

**Reports**  
1

**Reporting signal score**

15.0777
- **Event**  
blister

**Reports**  
26

**Reporting signal score**

35.7358
- **Event**  
burns second degree

**Reports**  
4

**Reporting signal score**

11.9814
- **Event**  
chemical burn

**Reports**  
7

**Reporting signal score**

34.5231
- **Event**  
chemical burn of skin

**Reports**  
25

**Reporting signal score**

153.806
- **Event**  
cough

**Reports**  
1

**Reporting signal score**

9.94136
- **Event**  
cranial nerve paralysis

**Reports**  
2

**Reporting signal score**

7.15371
- **Event**  
dermatitis

**Reports**  
33

**Reporting signal score**

83.8639
- **Event**  
dermatitis allergic

**Reports**  
12

**Reporting signal score**

20.4633
- **Event**  
dermatitis contact

**Reports**  
15

**Reporting signal score**

35.8743
- **Event**  
diarrhoea

**Reports**  
1

**Reporting signal score**

30.0511
- **Event**  
dizziness

**Reports**  
2

**Reporting signal score**

18.4688
- **Event**  
drug interaction

**Reports**  
2

**Reporting signal score**

7.40177

And 52 more, listed on the interactive page.

### Trial references (70)

- NCT00151541  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00151541)
- NCT00421993  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00421993)
- NCT00422240  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00422240)
- NCT00441415  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00441415)
- NCT00446043  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00446043)
- NCT00469755  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00469755)
- NCT00598832  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00598832)
- NCT00599521  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00599521)
- NCT00660985  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00660985)
- NCT00671749  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00671749)
- NCT00687908  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00687908)
- NCT00688064  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00688064)
- NCT00696449  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00696449)
- NCT00714714  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00714714)
- NCT00757523  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00757523)
- NCT00807014  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00807014)
- NCT00829049  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00829049)
- NCT00883233  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00883233)
- NCT00887484  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00887484)
- NCT00919191  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00919191)
- NCT00926367  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00926367)
- NCT00952523  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00952523)
- NCT01014689  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01014689)
- NCT01106807  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01106807)
- NCT01138735  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01138735)

And 45 more, listed on the interactive page.

## Dosing

**Route**

Topical

**How often**

Once daily

### Conditions of use (3)

- Apply at nighttime
- Apply to affected areas of the skin
- Use a thin film

## Chemical properties

**Hydrogen bond acceptors**

2

**Hydrogen bond donors**

1

**Polar surface area**

46.53

**Calculated partition coefficient (ALogP)**

6.68

**Calculated partition coefficient (XLogP)**

7.7

**Prodrug**

No

**Chirality**

Achiral

**Inorganic**

No

**Rule-of-five violations**

1

**Rotatable bonds**

4

**Heavy atoms**

31

**Molecular formula**

C28H28O3

**Monoisotopic mass**

412.20384475

**Natural product**

Yes

## National Drug Codes

- 0168-0424
- 0187-0006
- 0299-5906
- 0299-5918
- 0472-0126
- 0480-3154
- 21922-051
- 21922-052
- 45802-453
- 45802-846
- 45802-853
- 46708-549
- 46708-662
- 49908-118
- 59651-604
- 62332-549
- 62332-662
- 68308-662
- 68308-666
- 68462-301
- 72578-119
- 51672-1364
- 51672-1377
- 51672-1384
- 63629-8607

And 8 more, listed on the interactive page.

## Evidence counts

**Recorded assays**

1,065

**Active assays**

118

### Active assay types (4)

- Confirmatory
- Other
- Screening
- Summary

## Pharmacologic actions

- Anti-Inflammatory Agents, Non-Steroidal  
Source: [id.nlm.nih.gov](https://id.nlm.nih.gov/mesh/D000894.html)
- Dermatologic Agents  
Source: [id.nlm.nih.gov](https://id.nlm.nih.gov/mesh/D003879.html)

## Related records

### Trials (90)

- "A Comparative Clinical Evaluation of the Efficacy of Topical Adapalene, Benzoyl Peroxide Gel, Oral Lactobacillus Rhamnosus, D-chiro-inositol, Inulin Capsule, and Their Fixed Combination in Mild to Moderate Acne Vulgaris Patients."
- A Bioequivalence Study With Clinical Endpoints Comparing Adapalene and Benzoyl Peroxide Topical Gel 0.1%/2.5% (Actavis Mid-Atlantic LLC) To Epiduo™ (Adapalene and Benzoyl Peroxide) Gel 0.1%/2.5% (Galderma Laboratories, L.P.) in the Treatment of Mild to Severe Acne Vulgaris
- A Comparative Study of Adapalene Gel,0.3% Versus Tretinoin Emollient Cream, 0.05% for the Treatment of Photoaging
- A Comparative Study of the Tolerability of Two Combination Therapies for the Treatment of Acne
- A Phase 3 Study to Compare the Safety and Efficacy of 5% Dapsone Topical Gel, (DTG) Twice Daily in Combination With Once Daily Vehicle Control, Adapalene Gel 0.1% or Benzoyl Peroxide Gel 4%
- A Pilot Study to Evaluate The Efficacy of Adapalene 0.3% for Use in the Prevention and Treatment of Senile Purpura
- A Study Comparing Aczone® Plus Differin® Versus Duac® Plus Differin® in Patients With Severe Facial Acne
- A Study Comparing Adapalene Gel 0.1% and to Differin Gel in the Treatment of Acne Vulgaris
- [A Study Comparing Clindamycin Phosphate, Adapalene, and Benzoyl Peroxide Topical Gel 0.15%;3.1%;1.2% (Taro Pharmaceuticals U.S.A., Inc.) and CABTREO Topical Gel for the Treatment of Acne Vulgaris.](https://trialight.com/data/trial/a-study-comparing-clindamycin-phosphate-adapalene-and-ba9c70f3-fa12-4215-ac68-4e41d58205e0.md)
- A Study to Compare FCD105 Foam to Minocycline 3% Foam, Adapalene 0.3% Foam and Vehicle Foam.
- A Study to Demonstrate the Efficacy and Safety of Adapalene/Benzoyl Peroxide Topical Gel in Subjects With Acne Vulgaris
- A Study to Evaluate the Efficacy and Safety of Adapalene-Clindamycin Combination Gel in the Treatment of Acne Vulgaris
- A Study to Evaluate Tolerability of Two Topical Drug Products in the Treatment of Facial Acne
- A Treatment for Severe Inflammatory Acne Subjects
- A Treatment Regimen for Student Athletes With Mild to Moderate Acne Vulgaris
- Adapalene BPO Gel Pump, Moisturizer SPF 30 and Foam Wash in Patients With Mild to Moderate Acne Vulgaris
- Adapalene Gel 0.3% in the Treatment of Atrophic Acne Scars
- Adapalene Gel 0.3% Versus Tretinoin 0.05% Emollient Cream for Treatment of Photodamage
- Adapalene-Benzoy Peroxide (BPO) Gel in the Treatment of Acne Vulgaris as a 6-month Maintenance
- Adapalene-BPO Gel Associated With Doxycycline Hyclate 100 mg in the Treatment of Severe Acne Vulgaris

### Approved for (1)

- [Acne](https://trialight.com/data/condition/acne-02478aa3-966b-5ffb-a257-6dbe85c14e58.md)

### In development for (2)

- Molluscum contagiosum Phase 3
- [Skin disorder](https://trialight.com/data/condition/skin-disorder-c8e27943-0efd-5c2b-abce-01c2ef37e853.md) Phase 1

### Other linked conditions (1)

- Plantar wart

### Targets (3)

- [RARA](https://trialight.com/data/target/rara-2959559f-4bf2-521d-8bc1-82ff9abf008c.md) Retinoic acid receptor agonist
- [RARB](https://trialight.com/data/target/rarb-eabf3c7d-d020-5984-bdd9-707b0a22fd15.md) Retinoic acid receptor agonist
- [RARG](https://trialight.com/data/target/rarg-6d3144e7-fd88-518b-b9ce-03b2e914c345.md) Retinoic acid receptor agonist

---

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