- The author estimates that in 2016, there were approximately 615 million prevalent cases of acne worldwide, and forecasts that number to increase to 673 million prevalent cases by 2025.
- Approved drugs in the acne space target retinoic acid receptor, bacterial ribosome, bacterial protein synthesis, dihydropteroate synthetase, steroid 5a-reductase, estrogen receptor alpha, estrogen receptor beta, folate receptor, mineralocorticoid receptor, and progesterone receptor. These are commonly administered via the oral and topical routes.
- The majority of industry-sponsored drugs in active clinical development for acne are in Phase II, with only two drugs in NDA/BLA phase.
- Therapies in mid-to-late-stage development for acne focus on a variety of targets. The majority of the drugs in mid-to-late-stage development for acne are administered via the topical route, with the remainder being oral, subcutaneous, or intravenous formulations.
- High-impact upcoming events for drugs in the acne space include topline Phase II and Phase III trial results for BTX-1503 and olumacostat glasaretil, respectively, an estimated PDUFA date for Seysara, and Altreno’s NDA.
- There were 19 licensing and asset acquisition activities involving acne drugs during 2013-18, seven of which occurred in 2014. The exclusive 2017 license agreement between XOMA and Novartis, worth $454m for the global rights to XOMA’s program relating to gevokizumab, was the largest deal during the 2013-18 period.
- Yaz’s sales ranked highest among drugs available for acne during 2012-16. The clinical trials distribution across Phase I-IV indicates that the majority of trials for acne have been in late phases of development, with 57% of trials in Phase III-IV, and 43% in Phase I-II.
- The US has a substantial lead in the number of acne clinical trials globally. Germany leads the major EU markets, while Japan has the top spot in Asia.
- GlaxoSmithKline has the highest number of completed clinical trials for acne.
Approvals by country
KEY UPCOMING EVENTS
KEY REGULATORY EVENTS
Galderma Pioneers NDA Path Into OTC Acne Treatment Market
Indian Start-up Vyome Wins Milestone FDA Nod For Acne Studies
LICENSING AND ASSET ACQUISITION DEALS
Sato licenses Japanese rights to Novan's acne candidate SB204
CLINICAL TRIAL LANDSCAPE
Sponsors by status
Sponsors by phase
Acne Pipeline Yields Three Disappointments, One Win So Far In 2017
Xenon Down On Novel Acne Treatment Failure
List of Figures
Figure 1: Trends in prevalent cases of acne, 2016-25
Figure 2: Pipeline drugs for acne in the US
Figure 3: Pipeline drugs for acne, by country
Figure 4: Pipeline drugs for acne, by drug type
Figure 5: Pipeline drugs for acne, by classifications
Figure 6: Key upcoming events in acne
Figure 7: Licensing and asset acquisition deals in acne
Figure 8: Parent patents in acne
Figure 9: Clinical trials in acne
Figure 10: Top 10 drugs for clinical trials in acne
Figure 11: Top 10 companies for clinical trials in acne
Figure 12: Trial locations in acne
Figure 13: Acne trials sponsors, by status
Figure 14: Acne trials sponsors, by phase
List of Tables
Table 1: Prevalent cases of acne, 2016-25
Table 2: Marketed drugs for acne
Table 3: Approvals by country for acne
Table 4: Pipeline drugs for acne in the US
Table 5: Historical global sales, by drug ($m), 2012-16
Table 6: Forecasted global sales, by drug ($m), 2017-22