Uses
AKLIEF Cream is a retinoid indicated for the topical treatment of acne vulgaris in patients 9 years of age and older.
Source: US FDA prescribing information
- Presentations
- 1
- Brands
- 1
- Manufacturers
- 1
- Available from stock
- 0
Trifarotene is a retinoid indicated for the topical treatment of acne vulgaris in patients 9 years of age and older. It is available as cream for topical use. MedsAcross supplies Trifarotene for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.
Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review
Key facts
- Pharmacological class
- Retinoid
- ATC classification
- D10AD06 Trifarotene · Acne treatments, subgroup D10A, subgroup D10AD
- US FDA first approval
- 4 October 2019
- EU status
- Not recorded
- Orphan designation
- Not recorded
- WHO essential medicine
- Not recorded
- India (CDSCO)
- Not yet confirmed against CDSCO approval lists
- Routes
- Topical
- Dosage forms
- Cream
- Identifiers
- UNII 0J8RN2W0HKRxCUI 2205637CAS 895542-09-3DrugBank DB12808Q27236856
Clinical information
From the regulator-approved product information. Each section names its source.
How it works
Trifarotene is an agonist of retinoic acid receptors (RAR), with particular activity at the gamma subtype of RAR. Stimulation of RAR results in modulation of target genes which are associated with various processes, including cell differentiation and mediation of inflammation. The exact process by which trifarotene ameliorates acne is unknown.
Source: US FDA prescribing information
Dosing overview
Apply a thin layer of AKLIEF Cream to the affected areas once daily, in the evening, on clean and dry skin. One pump actuation should be enough to cover the face (i.e., forehead, cheeks, nose, and chin). Two actuations of the pump should be enough to cover the upper trunk (i.e., reachable upper back, shoulders and chest). One additional pump actuation may be used for middle and lower back if acne is present. The use of a moisturizer is recommended as frequently as needed from the initiation of treatment. Avoid contact with the eyes, lips, paranasal creases, mucous membranes. AKLIEF Cream is for topical use only. Not for oral, ophthalmic, or intravaginal use. For topical use only. Apply a thin layer of AKLIEF Cream to the affected areas of the face and/or trunk once a day, in the evening, on clean and dry skin. Avoid contact with the eyes, lips, paranasal creases, and mucous membranes.
Source: US FDA prescribing information
Contraindications
None None
Source: US FDA prescribing information
Warnings and precautions
Skin irritation: Erythema, scaling, dryness, and stinging/burning may be experienced with use of AKLIEF Cream. Use a moisturizer from the initiation of treatment, and, if appropriate, reduce the frequency of application of AKLIEF Cream, suspend or discontinue use. Ultraviolet Light and Environmental Exposure: Minimize exposure to sunlight and sunlamps. Use sunscreen and protective clothing over treated areas when exposure cannot be avoided.
Source: US FDA prescribing information
Side effects
Most common adverse reactions (incidence ≥ 1%) in patients treated with AKLIEF Cream were application site irritation, application site pruritus, and sunburn.
Source: US FDA prescribing information
Interactions
Topical application of AKLIEF Cream is not expected to affect the circulating concentrations of oral hormonal contraceptives containing ethinyl estradiol and levonorgestrel.
Source: US FDA prescribing information
Storage
- Store at 20˚ to 25˚C (68˚ to 77˚F), excursions permitted to 15° to 30°C (59° to 86°F). - Keep away from heat. - Keep out of reach of children.
Source: US FDA prescribing information
For healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
All presentations
1 presentations of Trifarotene, sorted by availability.
| Medicine | Manufacturer | Register | Availability |
|---|---|---|---|
| Aklief 50 mcg/g creamTopical | Galderma Laboratories | US FDA | Available on request |
Brands by market
1 brand names across 1 markets.
United States
Manufacturers
Regulatory status
Approval facts from US FDA, EMA and CDSCO data, and registration status by country where we hold register data.
| Register | Status | Source |
|---|---|---|
| US FDA | First approved 4 October 2019 | Drugs@FDA |
| EU (EMA) | Not recorded | — |
| India (CDSCO) | Not yet confirmed against CDSCO approval lists | — |
| United States | Registered | US FDA (NDC directory, openFDA)Checked 12 November 2026 |
Questions and answers
Is Trifarotene available for export from India?
Yes, on request. MedsAcross lists 1 presentations of Trifarotene and sources them for licensed hospitals, importers and physicians against valid import documents.
What brand names does Trifarotene have?
The catalogue lists 1 brand names for Trifarotene, including Aklief.
Is Trifarotene approved by the US FDA?
Yes. The US FDA first approved Trifarotene on 4 October 2019, according to Drugs@FDA.
Does Trifarotene need cold chain shipping?
No listed presentation of Trifarotene is recorded as needing a cold chain. Storage conditions are shown on each presentation page.
Which ATC class is Trifarotene in?
Trifarotene is classified under ATC code D10AD06 (Trifarotene).
References
- AKLIEF prescribing information (Galderma Laboratories). U.S. National Library of Medicine, DailyMed. Retrieved 16 September 2024
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