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Qwo FDA Approval History

Last updated by Judith Stewart, BPharm on July 9, 2020.

FDA Approved: Yes (First approved July 6, 2020)
Brand name: Qwo
Generic name: collagenase clostridium histolyticum-aaes
Dosage form: for Injection
Company: Endo International plc
Treatment for: Cellulite

Qwo (collagenase clostridium histolyticum-aaes) is a combination of bacterial collagenases indicated for the treatment of moderate to severe cellulite in the buttocks of adult women.

  • Qwo is thought to enzymatically release the fibrous septae which pull the skin to the muscle fascia to cause the characteristic dimpling appearance of cellulite.
  • Qwo is administered via subcutaneous injection into the treatment area of the buttocks. Each buttock can receive up to 12 injections per treatment visit. Treatment visits should be repeated every 21 days for 3 treatment visits.
  • The most common adverse reactions (≥ 1%) were related to the injection site (bruising, pain, nodule, pruritus, erythema, discoloration, swelling, and warmth).

Development timeline for Qwo

Jul  6, 2020Approval FDA Approves Qwo (collagenase clostridium histolyticum-aaes) as the First Injectable Treatment for Cellulite
Nov 19, 2019Endo Announces FDA's Acceptance of Original Biologics License Application (BLA) for Collagenase Clostridium Histolyticum (CCH) in Patients with Cellulite
Sep  6, 2019Endo Announces Submission of Biologics License Application to FDA for Collagenase Clostridium Histolyticum (CCH) in Patients with Cellulite
Mar 19, 2019Endo Announces Publication Of Collagenase Clostridium Histolyticum (CCH) Phase 2 Data In Dermatologic Surgery
Nov  7, 2018Endo Announces Positive Results from Phase 3 Studies of Collagenase Clostridium Histolyticum (CCH) in Patients with Cellulite
Feb  6, 2018Endo Announces Initiation Of Two Pivotal Phase 3 Clinical Trials Of Collagenase Clostridium Histolyticum For The Treatment Of Cellulite

Further information

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