- The author estimates that in 2016, there were approximately 112.2 million (NIH criteria) to 186.9 million (Rotterdam criteria) prevalent cases of polycystic ovary syndrome (PCOS) in females aged 15-49 years worldwide, and expects that number to increase to between 118.0 million (NIH criteria) and 196.6 million (Rotterdam criteria) by 2025.
- The approved drugs in the PCOS space target estrogen receptor 1, androgen receptor, and follicle stimulating hormone receptor. These drugs are commonly administered via the oral and subcutaneous routes, with one product being available in intramuscular formulation.
- The majority of industry-sponsored drugs in active clinical development for PCOS are in Phase II, with only one drug in Phase III. Therapies in the pipeline for PCOS focus on targets such as AMP-activated protein kinase, neurokinin receptor, and SGLT. All of the pipeline drugs are administered orally.
- There was only one licensing agreement during 2013-18. The deal was an exclusive licensing agreement between Millendo and AstraZeneca for the worldwide development and commercialization rights to MLE4901.
- The clinical trials distribution across Phase I-IV indicates that the majority of trials for PCOS have been in Phases III-IV, accounting for 82% of trials, while only 18% of trials are in Phase II.
- The US has a substantial lead in the number of PCOS clinical trials globally. Germany and the UK lead the major EU markets, while Indonesia and South Korea have the joint top spot in Asia.
- Clinical trial activity in the PCOS space is dominated by completed trials. Merck KGaA has the highest number of completed clinical trials for PCOS, with five in total.
- Merck KGaA leads industry sponsors with the highest number of clinical trials for PCOS, followed by AstraZeneca and Merck & Co.
Oral contraceptive pills
Approvals by country
LICENSING AND ASSET ACQUISITION DEALS
CLINICAL TRIAL LANDSCAPE
Sponsors by status
Sponsors by phase
List of Figures
Figure 1: Trends in prevalent cases of PCOS (Rotterdam Criteria), 2016-25
Figure 2: Trends in prevalent cases of PCOS (NIH Criteria), 2016-25
Figure 3: Pipeline drugs for PCOS in the US
Figure 4: Pipeline drugs for PCOS, by company
Figure 5: Pipeline drugs for PCOS, by drug type
Figure 6: Pipeline drugs for PCOS, by drug classification
Figure 7: Licensing and asset acquisition deals in PCOS
Figure 8: Clinical trials in PCOS
Figure 9: Top 10 drugs for clinical trials in PCOS
Figure 10: Top 10 companies for clinical trials in PCOS
Figure 11: Trial locations in PCOS
Figure 12: PCOS trials sponsors, by status
Figure 13: PCOS trials sponsors, by phase
List of Tables
Table 1: Prevalent cases of PCOS (Rotterdam Criteria), 2016-25
Table 2: Prevalent cases of PCOS (NIH Criteria), 2016-25
Table 3: Marketed drugs for PCOS
Table 4: Approvals by country for PCOS
Table 5: Pipeline drugs for PCOS in the US
Table 6: Parent patents in PCOS