New Medicines

Winlevi Acne vulgaris in patients aged 9 years and older


New molecular entity

Development and Regulatory status

Phase III Clinical Trials
Phase III Clinical Trials
Approved (Licensed)
Jan 22No plans for development in the EU or UK described however company does state an ongoing strategy to partner products outside the US [8].
Nov 20Winlevi 1% cream is expected to launch in the US in Q1 2021 [7]
Aug 20Approved by FDA [6].
Aug 19Filed in US [6].
Nov 18Cassiopea hope to launch Winlevi in the second half of 2020 [5].
Sep 15Cassiopea projects completion of PIII development in H2 2017, with expected launch in 2018 [2].


Steroid ester, CB 03 01 (cortexolone 17α-propionate) is derived from 11-deoxycortisone, and antagonises androgen receptors in the skin, thereby preventing stimulating effects of testosterone and dihydrotestosterone on hair follicles and sebaceous gla nds
Almost every teenager can expect to experience acne to some degree during the adolescent years although it is usually mild. Moderate-to-severe acne affects about 20% of young people [1].
Acne vulgaris in patients aged 9 years and older

Trial or other data

Apr 20Data from two PIII studies (NCT02608450 and NCT02608476; n=1440) showed that use of clascoterone cream, was associated with greater treatment success vs treatment with vehicle, with reductions in absolute non-inflammatory and inflammatory lesion counts [5].
Oct 18Cassiopea have announced that the Winlevi™ PIII clinical trial programme has demonstrated highly statistically significant improvements for all primary and secondary clinical end-points, and that the drug is generally safe and well tolerated. Cassiopea plans to present the data at a future medical meeting and also for consideration for publication in a peer-reviewed journal [4].
Oct 17PIII studies (NCT02608476 and NCT02608450) are still recruiting. Collection of primary outcome data expected to complete Dec 17 [3].
Mar 16PIII trial to investigate the long-term safety of CB 03 01 cream applied twice daily for an additional nine months in study participants with acne vulgaris that participated in the pivotal phase III studies (CB-03-01/25 and CB-03-01/26) for a total treatment of up to 12 months starts (NCT02682264; CB-03-01/27). The open-label trial is enrolling approximately 600 participants in the US [2].
Nov 15PIII trial to investigate the safety and efficacy of CB 03 01 cream for 12 weeks in participants with facial acne vulgaris starts (NCT02608450; CB-03-01/25). The double-blind, randomised trial will enrol approximately 700 participants in the US [2].
Nov 15PIII trial to determine the safety and efficacy of CB 03 01 cream 1%, as compared with the vehicle cream, applied twice daily for 12 weeks, in patients with facial acne vulgaris starts (CB-03-01/26; NCT02608476). The primary endpoints are the proportion of subjects achieving success at week 12 with an IGA score of “clear” (score = 0) or “almost clear” and at least a two-point reduction in IGA and an absolute change from baseline in both inflammatory and non-inflammatory lesion counts in each treatment group at week 12. The double-blind, randomised, parallel trial is recruiting 700 patients in the US [2].
Nov 15Cassiopea announceds that the Winlevi™ PIII clinical trial programme will consist of two pivotal trials and intends to enrol 1,400 subjects aged 9 years or older with moderate to severe acne (grades 3-4) in the US and Europe [2].