- The author estimates that in 2016, there were approximately 90.7 million prevalent cases of uterine fibroids worldwide in females aged 15 years and over, and forecasts that number to increase to 101.0 million prevalent cases by 2025.
- Ulipristal acetate, a selective progesterone receptor modulator, is the only marketed drug for uterine fibroids. It reversibly blocks the progesterone receptor in its target tissues, and acts as a potent, orally active antiprogestational agent. For moderate to severe symptoms of uterine fibroids, ulipristal acetate is marketed by Gedeon Richter as Esmya in Europe and by Allergan as Fibristal in Canada.
- The majority of industry-sponsored drugs in active clinical development for uterine fibroids are in Phase III, with only ulipristal acetate at the NDA/BLA stage in the US.
- Therapies in mid-to-late-stage development for uterine fibroids focus on targets such as the progesterone receptor and gonadotropin-releasing hormone receptor. All therapies in mid-to-late-stage development are administered orally.
- High-impact upcoming events for drugs in the uterine fibroids space comprise topline Phase III trial results for relugolix, and a PDUFA date for ulipristal acetate’s NDA.
- There were seven licensing agreements involving uterine fibroids drugs during 2012-17, all of which have taken place in the last four years.
- The distribution of clinical trials across Phase I-IV indicates that the majority of trials for uterine fibroids have been in the early and mid-phases of development, with 64% of trials in Phase I-II, and 36% in Phase III-IV.
- The US has a substantial lead in the number of uterine fibroids clinical trials globally. Belgium and Poland lead the EU markets, while Japan has the top spot in Asia.
- Clinical trial activity in the uterine fibroids space is dominated by completed trials. Repros Therapeutics and Takeda have the highest numbers of completed clinical trials for uterine fibroids, with 17 and 15 completed trials, respectively.
- Repros Therapeutics leads industry sponsors with by far the highest number of clinical trials for uterine fibroids, followed by Takeda and Gedeon Richter.
Approvals by country
KEY UPCOMING EVENTS
LICENSING AND ASSET ACQUISITION DEALS
CLINICAL TRIAL LANDSCAPE
Sponsors by status
Sponsors by phase
List of Figures
Figure 1: Trends in prevalent cases of uterine fibroids, 2016-25
Figure 2: Overview of pipeline drugs for uterine fibroids in the US
Figure 3: Pipeline drugs for uterine fibroids, by company
Figure 4: Pipeline drugs for uterine fibroids, by drug type
Figure 5: Pipeline drugs for uterine fibroids, by classifications
Figure 6: Key upcoming events in uterine fibroids
Figure 7: Licensing and asset acquisition deals in uterine fibroids, 2013-18
Figure 8: Parent patents in uterine fibroids
Figure 9: Clinical trials in uterine fibroids
Figure 10: Top 10 drugs for clinical trials in uterine fibroids
Figure 11: Top 10 companies for clinical trials in uterine fibroids
Figure 12: Trial locations in uterine fibroids
Figure 13: Uterine fibroids trials status
Figure 14: Uterine fibroids trials sponsors, by phase
List of Tables
Table 1: Prevalent cases of uterine fibroids, 2016-25
Table 2: Marketed drugs for uterine fibroids
Table 3: Approvals by country for uterine fibroids
Table 4: Pipeline drugs for uterine fibroids in the US