MATERNAL HEALTH MEDICINES PIPELINE

Our approach was to create a comprehensive database profiling all medicines (drugs, biologics and dietary supplements) investigated since 2000 for each pregnancy-related condition. Medicines could be applicable for use in any context and the medicine candidates needed to: 

• Be small molecules (drugs), biologics or dietary supplements, with no restrictions: candidates could be entirely new entities; existing/repurposed/label extensions; new formulations or dosing of existing/registered medicines
• Have an indication or multiple indications related to the project’s five identified pregnancy-related conditions: preterm labour/birth, preeclampsia/ eclampsia, intrauterine growth restriction, postpartum haemorrhage, foetal distress 
• Either be in active development, or have been at one point between 2000 and 2020 (public announcements and updates on relevant candidates made between January and May 2021 were also captured in their respective profiles) 
• Be either investigated for clinical use and/or used currently in clinical treatment of the five identified conditions 

Specific exclusions were: devices, diagnostics, and other non-medicine-related biomedical products with indications specific to the project’s five pregnancy-related conditions

We undertook a series of partially sequential, partly overlapping, but mutually reinforcing steps to develop a database of candidate profiles. These were:

1. Identify and validate candidates through multiple sources that are or were in the pipeline for each of the identified pregnancy-related conditions since 2000;
2. Collect information on the candidate’s preclinical or clinical development, and associated data;
3. Research additional context around the product (e.g. development history, stakeholders)
4. Validate and sense check candidate profiles through independent, external reviews by clinical research specialists in the field.

For a more detailed description of the methodology, see here.

We identified a total of 444 candidates, of which 224 (50.4%) were in active preclinical/clinical development and 220 (49.6%) were inactive. This does include some duplicate medicines that have been investigated for multiple conditions. In all, there were 344 truly unique candidates contained within the dataset.

• In total, 64% (284) of the candidates were drugs, 13% (59) were biologics, and 23% (101 candidates) were dietary supplements. 
• Two thirds of candidates for all conditions were repurposed (291 candidates, 66%), with the remaining (153 candidates, 34%) new chemical/biological entities. This divide becomes even more pronounced when we narrow our look at active candidates, 74% of which (166 candidates) were repurposed and 26% new chemical entities (NCEs) (58 candidates).  
• A large portion (81%) of all new chemical/biological entity candidates (124) have only been investigated in preclinical stages, underscoring the dominance of repurposed medicines in the clinical development landscape for these conditions. This makes sense in context– where moving forward with promising candidates already marketed and proven safe in pregnancy is an attractive (and more pragmatic) option – and highlights the structural challenges of advancing NCEs for obstetric conditions more broadly.