Background The Accelerating Innovation for Mothers (AIM) project established a database of candidate medicines in research and development (R&D) between 2000 and 2021 for five pregnancy-related conditions, including pre-eclampsia. In parallel, we published target product profiles (TPPs) that describe optimal characteristics of medicines for use in preventing/treating pre-eclampsia. The study objective was to use systematic double screening and extraction to identify all candidate medicines being investigated for pre-eclampsia prevention/treatment and rank their potential based on the TPPs. Methods Adis Insight, Pharmaprojects, WHO international clinical trials registry platform (ICTRP), PubMed and grant databases were searched (Jan–May 2021). The AIM database was screened for all candidates being investigated for pre-eclampsia. Candidates in clinical development were evaluated against nine prespecified criteria from TPPs identified as key for wide-scale implementation, and classified as high, medium or low potential based on matching to the TPPs. Preclinical candidates were categorised by product type, archetype and medicine subclass. Results The AIM database identified 153 candidates for pre-eclampsia. Of the 87 candidates in clinical development, seven were classified as high potential (prevention: esomeprazole, l-arginine, chloroquine, vitamin D and metformin; treatment: sulfasalazine and metformin) and eight as medium potential (prevention: probiotic lactobacilli, dalteparin, selenium and omega-3 fatty acid; treatment: sulforaphane, pravastatin, rosuvastatin and vitamin B3). Sixty-six candidates were in preclinical development, the most common being amino acid/peptides, siRNA-based medicines and polyphenols. Conclusions This is a novel, evidence-informed approach to identifying promising candidates for pre-eclampsia prevention and treatment — a vital step in stimulating R&D of new medicines for pre-eclampsia suitable for real-world implementation.

Objective The Accelerating Innovation for Mothers project established a new database of candidate medicines under development between 2000 and 2021 for five pregnancy‐related conditions, including fetal growth restriction. The objective was to assess medicines for fetal growth restriction and their potential for clinical use globally. Design Landscape analysis. Setting Global (focus on low‐ and middle‐income countries, LMICs). Sample Drugs, dietary supplements and biologics under investigation for prevention or treatment of fetal growth restriction. Methods A research pipeline database of medicines was created through searching AdisInsight, PubMed and various grant and clinical trial databases. Analysis of clinical and preclinical candidates were descriptive. Main Outcomes Measures Fetal growth restriction candidates in clinical development were identified and ranked as high, medium or low potential based on prespecified criteria, including efficacy, safety and accessibility. Results Of the 444 unique candidates in the database across all five pregnancy‐related conditions, 63 were for fetal growth restriction. Of these, 31 were in clinical development (phases I, II or III) and 32 were in preclinical development. Three candidates, aspirin, l‐arginine and vitamin D, were ranked as having high potential as preventive agents. There were no high‐potential candidates for treating fetal growth restriction, although five candidates were ranked as having medium potential: allylestrenol, dalteparin, omega‐3 fatty acids, tadalafil, and United Nations International Multiple Micronutrient Antenatal Preparation (UNIMMAP). Conclusions l‐Arginine, aspirin and vitamin D are promising, high‐potential preventative agents for fetal growth restriction. Based on the medicines pipeline, new pharmacological agents for fetal growth restriction are unlikely to emerge in the near future.

BackgroundA significant barrier to improving prevention and treatment of postpartum hemorrhage (PPH) is a lack of innovative medicines that meet the needs of women and providers, particularly those in low‐and middle‐income countries (LMICs). The Accelerating Innovation for Mothers (AIM) project established a new database of candidate medicines under development for five pregnancy‐related conditions between 2000 and 2021.ObjectiveTo systematically identify and rank candidates for prevention and treatment of PPH.Search StrategyAdis Insight, Pharmaprojects, WHO ICTRP, PubMed, and grant databases were searched to develop the AIM database.Selection CriteriaAIM database was searched for candidates being evaluated for PPH prevention and treatment, regardless of phase.Data Collection and AnalysisCandidates were ranked as high, medium, or low potential based on prespecified criteria. Analysis was primarily descriptive, describing candidates and development potential.Main ResultsOf the 444 unique candidates, only 39 pertained to PPH. One was high potential (heat‐stable/inhaled oxytocin) and three were medium potential (melatonin, vasopressin and dofetilide via nanoparticle delivery).ConclusionThe pipeline for new PPH medicines is concerningly limited, lacking diversity, and showing little evidence of novel technologies. Without significant investment in early‐phase research, it is unlikely that new products will emerge.

ObjectiveTo develop target product profiles (TPPs) for new medicines for preterm birth prevention and preterm labour management that address the real‐world need of women and healthcare providers, informed by views and agreement amongst globally diverse stakeholders.DesignMixed methods.SettingGlobal (with a focus on low‐ and middle‐income countries, LMICs).SampleGlobal stakeholders with diverse expertise in preterm labour/birth and drug development.MethodsFollowing an initial literature review, diverse stakeholders were invited to participate in an online international survey and in‐depth interviews. The level of stakeholder agreement with TPPs was assessed, and findings from interviews were synthesised to inform the final TPPs.Main outcomes measuresLevel of stakeholder agreement on the minimum and preferred requirements for preterm labour/birth medicines.ResultsWe performed 21 interviews. Interview participants demonstrated strong agreement on room temperature stability, no additional drug‐specific clinical monitoring, and affordability in LMICs being the minimal acceptable requirements. Points of discussion were raised around the target population. Survey respondents included clinicians, researchers, funding agency staff, international public organisation staff, programme implementers, policymakers, representatives of consumer advocacy organisations and other relevant stakeholders from maternal health systems. Survey results indicated strong agreement amongst stakeholders, with only one variable in each TPP not reaching consensus (i.e. 25% disagree or strongly disagree).ConclusionsThere is strong consensus within the preterm labour/birth community on the characteristics that new medicines for preterm birth prevention and preterm labour management must achieve. These TPPs provide necessary guidance to evaluate new candidates and their potential for implementation in a range of settings.

Background There are few medicines in clinical use for managing preterm labor or preventing spontaneous preterm birth from occurring. We previously developed two target product profiles (TPPs) for medicines to prevent spontaneous preterm birth and manage preterm labor. The objectives of this study were to 1) analyse the research and development pipeline of medicines for preterm birth and 2) compare these medicines to target product profiles for spontaneous preterm birth to identify the most promising candidates. Methods Adis Insight, Pharmaprojects, WHO international clinical trials registry platform (ICTRP), PubMed and grant databases were searched to identify candidate medicines (including drugs, dietary supplements and biologics) and populate the Accelerating Innovations for Mothers (AIM) database. This database was screened for all candidates that have been investigated for preterm birth. Candidates in clinical development were ranked against criteria from TPPs, and classified as high, medium or low potential. Preclinical candidates were categorised by product type, archetype and medicine subclass. Results The AIM database identified 178 candidates. Of the 71 candidates in clinical development, ten were deemed high potential (Prevention: Omega-3 fatty acid, aspirin, vaginal progesterone, oral progesterone, L-arginine, and selenium; Treatment: nicorandil, isosorbide dinitrate, nicardipine and celecoxib) and seven were medium potential (Prevention: pravastatin and lactoferrin; Treatment: glyceryl trinitrate, retosiban, relcovaptan, human chorionic gonadotropin and Bryophyllum pinnatum extract). 107 candidates were in preclinical development. Conclusions This analysis provides a drug-agnostic approach to assessing the potential of candidate medicines for spontaneous preterm birth. Research should be prioritised for high-potential candidates that are most likely to meet the real world needs of women, babies, and health care professionals.