Skip to main content

Aklief FDA Approval History

Last updated by Judith Stewart, BPharm on Jan 27, 2021.

FDA Approved: Yes (First approved October 4, 2019)
Brand name: Aklief
Generic name: trifarotene
Dosage form: Topical Cream
Company: Galderma Laboratories, L.P.
Treatment for: Acne

Aklief (trifarotene) is a topical retinoid indicated for the treatment of acne vulgaris in patients 9 years of age and older.

  • Trifarotene is the first new retinoid approved by the FDA for the treatment of acne in over 20 years.
  • Trifarotene is the only topical retinoid that selectively targets retinoic acid receptor (RAR) gamma, the most common RAR found in the skin.
  • Aklief Cream is the first topical treatment specifically studied and proven to treat both facial acne (forehead, cheeks, nose and chin) and truncal acne (chest, shoulders and back).
  • Aklief Cream is applied thinly to the affected areas of the face and/or trunk once a day in the evening.
  • Common side effects include application site irritation, application site pruritus (itching), and sunburn.

Development timeline for Aklief

Oct  4, 2019Approval FDA Approves Aklief (trifarotene) Cream, a New Topical Retinoid for the Treatment of Acne

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.