> Trialight public data. Index of pages: https://trialight.com/llms.txt
> Web page: https://trialight.com/data/asset/trifarotene-374e6666-2c7c-4657-8768-537a166f52b8
> Record changed: 2026-10-13

# Trifarotene

Highest phase reached

Approved

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL3707313)

Drug type

Small molecule

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL3707313)

First approval year

2019

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL3707313)

## Development status

**First approval year**

2019

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL3707313)

**Listing at source**

Listed

**Highest phase reached**

Approved

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL3707313)

## Names and chemistry

**Drug type**

Small molecule

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL3707313)

**Drug name**

Trifarotene

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL3707313)

**Molecular weight**

459.59

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL3707313)

**Structure (SMILES)**

CC(C)(C)c1cc(-c2cc(-c3ccc(C(=O)O)cc3)ccc2OCCO)ccc1N1CCCC1

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL3707313)

### Brand names (2)

- aklief
- Aklief

### Other names (23)

- aklief
- AKLIEF®
- cd 5789
- CD-5789
- cd5789
- CD5789
- CD5789 (trifarotene)
- trifarotene
- Trifarotene
- trifarotene \[INN\]
- TRIFAROTENE \[MI\]
- TRIFAROTENE \[ORANGE BOOK\]
- TRIFAROTENE \[USAN\]
- Trifarotene \[WHO-DD\]
- Trifarotene cream
- Trifarotene Cream
- trifarotene inn
- trifarotene mi
- trifarotene orange book
- trifarotene usan
- trifarotene who dd
- trifaroteno
- Trifaroteno

## Identifiers

**ATC classification codes**

- D10AD06

Sources for recorded values

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL3707313)

**CAS registry numbers**

- 895542-09-3

**ChEMBL ID**

CHEMBL3707313

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL3707313)

**InChIKey**

MFBCDACCJCDGBA-UHFFFAOYSA-N

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL3707313)

**PubChem compound IDs**

- 11518241

**RxNorm IDs (RxCUI)**

- 2205637

**FDA ingredient codes (UNII)**

- 0J8RN2W0HK

## Regulatory information

### United States

**Applicant**

GALDERMA LABS LP

**Approval date**

4 Oct 2019

**Application number**

NDA211527

### Other regulatory facts

**Patents**

3

**Designations**

1

**Earliest recorded loss of exclusivity**

30 May 2033

**First in class**

No

**Fast track**

No

**Breakthrough designation**

No

**Orphan designation**

No

**Priority review**

No

**Orphan exclusivity**

No

**Accelerated approval**

No

**Availability**

Prescription only

## Pharmacology

### Drug classification

**Pharmacology name**

trifarotene

**Type**

Synthetic organic

**Drug name stem**

\-arotene

**Approval recorded by Guide to Pharmacology**

Yes

#### Administration routes

- topical

### Mechanisms of action (4)

- **Action**  
Agonist

**Action type**  
Agonist

**Target**  
Retinoic acid receptor-α

**Gene symbol**  
RARA

**Protein identifier**  
P10276

**Median affinity**

6.3

**Affinity units**  
pEC50
- **Action**  
Agonist

**Action type**  
Agonist

**Target**  
Retinoic acid receptor-β

**Gene symbol**  
RARB

**Protein identifier**  
P10826

**Median affinity**

6.9

**Affinity units**  
pEC50
- **Action**  
Agonist

**Action type**  
Agonist

**Target**  
Retinoic acid receptor-γ

**Gene symbol**  
RARG

**Protein identifier**  
P13631

**Median affinity**

8.11

**Affinity units**  
pEC50

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

**Action type**  
Agonist

**Target**  
Retinoic acid receptor gamma

**Protein identifier**  
P13631

### Open Targets mechanisms

- **Mechanism**  
Retinoic acid receptor gamma agonist

**Action type**  
Agonist

**Target**  
Retinoic acid receptor gamma

### DrugCentral mechanisms (3)

- **Action type**  
Agonist

**Gene symbol**  
RARA

**Protein identifier**  
P10276

**Organism**  
Homo sapiens

**Target development level**  
Clinical
- **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**  
Lymphoma

**Highest recorded phase**  
1

**Condition identifier**  
EFO:0000574

**Subject identifier**  
D008223
- **Condition**  
Acne Vulgaris

**Highest recorded phase**  
4

**Condition identifier**  
EFO:0003894

**Subject identifier**  
D000152
- **Condition**  
Ichthyosis, Lamellar

**Highest recorded phase**  
2

**Condition identifier**  
MONDO:0017778

**Subject identifier**  
D017490

### Open Targets indications (5)

- **Condition identifier**  
EFO\_0000574

**Highest recorded phase**  
1
- **Condition identifier**  
EFO\_0003894
- **Condition identifier**  
MONDO\_0000607

**Highest recorded phase**  
1
- **Condition identifier**  
MONDO\_0011438

**Highest recorded phase**  
4
- **Condition identifier**  
MONDO\_0017778

**Highest recorded phase**  
2

### Trial references (9)

- NCT01804335  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01804335)
- NCT02189629  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT02189629)
- NCT03915860  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT03915860)
- NCT04451330  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04451330)
- NCT04856904  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04856904)
- NCT05089708  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05089708)
- NCT05550337  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05550337)
- NCT06063473  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06063473)
- NCT03738800  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT03738800)

## Dosing

**Dose**

One pump actuation for face, two actuations for upper trunk, optionally one more for back if acne present

**Route**

Topical

**How often**

Once daily

### Conditions of use (4)

- Apply in the evening
- Apply to affected areas of face and/or trunk
- Avoid contact with eyes, lips, creases, mucous membranes
- On clean and dry skin

## Chemical properties

**Hydrogen bond acceptors**

4

**Hydrogen bond donors**

2

**Polar surface area**

70

**Calculated partition coefficient (ALogP)**

5.99

**Calculated partition coefficient (XLogP)**

6.3

**Prodrug**

No

**Chirality**

Achiral

**Inorganic**

No

**Rule-of-five violations**

1

**Rotatable bonds**

7

**Heavy atoms**

34

**Molecular formula**

C29H33NO4

**Monoisotopic mass**

459.24095853

**Natural product**

Yes

## National Drug Codes

- 0299-5935

## Evidence counts

**Recorded assays**

12

**Active assays**

6

### Active assay types

- Confirmatory

## Pharmacologic actions

- Dermatologic Agents  
Source: [id.nlm.nih.gov](https://id.nlm.nih.gov/mesh/D003879.html)

## Biological measurements

### Observed measurements

#### Distribution coefficient (LogD)

**Median**

3.5

**Mean**

3.5

**Minimum**

3.5

**Maximum**

3.5

**Unit**

unitless

**Assays**

1

**Standard deviation**

0

**Summary method**

median

**Censored results excluded**

0

**Other units excluded**

0

**Unknown units excluded**

0

#### Measurement types

- LogD

## Related records

### Trials (14)

- A Safety, Efficacy and Systemic Exposure Study of CD5789 Cream in Adults and Adolescents With Lamellar Ichthyosis
- [A Study Comparing Trifarotene Cream 0.005% to AKLIEF® CREAM (US REFERENCE LISTED DRUG), AKLIEF™ CREAM (CANADIAN REFERENCE PRODUCT) in the Treatment of Acne Vulgaris](https://trialight.com/data/trial/a-study-comparing-trifarotene-cream-0-005-to-aklief-cream-us-b331bee6-fb6a-4c0a-aa75-5a4a9bf31b9e.md)
- [A Study Comparing Trifarotene Cream 0.005% to AKLIEF® Cream in the Treatment of Acne Vulgaris](https://trialight.com/data/trial/a-study-comparing-trifarotene-cream-0-005-to-aklief-cream-in-8c339358-1fe0-4cf4-add8-468f4b7cf3e9.md)
- A Study to Compare Efficacy and Safety of Trifarotene Cream When Used With an Oral Antibiotic for the Treatment of Severe Acne Vulgaris (AV)
- A Study to Compare the Efficacy, Safety and Pharmacokinetics of Trifarotene 50 mcg/g Cream in Chinese Subjects With Acne Vulgaris
- AkLief Evaluation in Acne-induced Post-Inflammatory Hyperpigmentation
- CD5789 (Trifarotene) Long Term Safety Study on Acne Vulgaris
- CD5789 in Early Cutaneous T-Cell Lymphoma (CTCL)
- Dose Range Study of CD5789 in Acne Vulgaris
- Double-Blind Efficacy and Safety of CD5789 (Trifarotene) 50µg/g Cream Versus Vehicle Cream in Acne Vulgaris
- Efficacy and Safety of CD5789 (Trifarotene) 50μg/g Cream Versus Vehicle Cream in Acne Vulgaris
- Participant Reported Outcomes With Use of Trifarotene 50 μg/g Cream in the Treatment of Moderate Facial and Truncal Acne Vulgaris
- Study Comparing Trifarotene Cream, 0.005% To AKLIEF ® (Trifarotene 0.005% Cream) In The Treatment Of Acne Vulgaris
- Study of Trifarotene Cream to Assess Risk of a Trophic Acne Scar Formation

### Approved for (1)

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

### In development for (2)

- Lamellar ichthyosis Phase 2
- [Lymphoma](https://trialight.com/data/condition/lymphoma-de4db685-7419-5e0e-b958-4591ffd69d43.md) Phase 1

### Targets (1)

- [RARG](https://trialight.com/data/target/rarg-6d3144e7-fd88-518b-b9ce-03b2e914c345.md) Retinoic acid receptor gamma agonist

---

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