Gynaecological Conditions Pipeline

Table 1: Scope of pipeline

The pipeline we developed is candidate-focused (as opposed to clinical trial-focused) presenting a profile for each candidate identified. It focuses on active candidates, with evidence of activity between 2021 and 2024, and products (marketed, approved or adopted in clinical practice the gold standard – e.g. diagnostic tests).

Endometriosis

Captured products include drugs, biologics, devices and combinations, and diagnostics, approved or under investigation for the prevention, treatment and detection of endometriosis.

For inclusion in the pipeline dataset, medicine entries must:

• be drugs (small molecules intended for use in the cure, mitigation, treatment, or prevention of disease), biologics (animal or non-animal derived, immunoglobulins or non-immunoglobulin products) or devices and combinations (an instrument or appliance, either with or without a pharmacological element, intended to facilitate the delivery of a drug or biologic, prevent STI transmission or control uterine bleeding)¹; with no restrictions: they can be entirely new entities; existing/repurposed or with label extensions; new formulations or dosing of existing/registered medicines.
• be preventive or therapeutic in nature – used to prevent or treat symptoms related to endometriosis, such as pain, endometrial tissue migration, endometrial lesions and endometriosis-related infertility; this includes medicines regulating the menstrual cycle;
• have one or multiple indications related to endometriosis;
• either be in active discovery, pre-clinical or clinical development since 2021, or be approved and registered for clinical use and/or be used currently in clinical treatment (off-label), and;
• be applicable for use in LMIC context.

For inclusion in the pipeline dataset, diagnostic entries must:

• be predictive/screening and/or diagnostic tests, with no restrictions: biochemical serum markers; non-biomarker tests; or fixed multiparametric tests;
• have an indication or multiple indications related to endometriosis;
• either be in active discovery, pre-clinical or clinical development since 2021, or be approved and registered for clinical use and/or be used currently in clinical treatment (off-label), and;
• be applicable for use in LMIC context.

Exclusions:

• Surgical interventions to treat or diagnose endometriosis are excluded;
• Dietary supplements are excluded;
• Predictive/diagnostic strategies, algorithms with no identifiable products; or that include risk models that combine multiple individual parameters/tests as a single candidate entry (for example several individual biomarkers which diagnostic utility is evaluated separately and not as a combined test usable in the clinic);
• Clinical guidelines or criteria that are not a biomedical product are excluded.

¹ A device (in the context of the G-FINDER scope) is defined as an instrument, appliance, or other similar article intended to be used either to prevent pregnancy directly (e.g. copper intrauterine device) or facilitate the delivery or removal of a contraceptive (e.g. intrauterine inserter), to control uterine bleeding (e.g. tools to assist bimanual compression in post-partum haemorrage), or to clear HPV infection or treat cervical lesions (e.g. handheld thermal ablation devices). To be classified as a “device”, the technology must not contain a pharmaceutical element. A combination product is defined as the combination of an instrument, appliance, or other similar article with a pharmaceutical element which are intended to prevent pregnancy, the transmission of HIV or other STIs, or to halt abnormal uterine bleeding. To be classified as a “combination product”, the therapeutic properties of the product must only be achieved when the instrument and pharmaceutical element are used in conjunction – i.e. the instrument is involved in the delivery of the drug or biologic (e.g. contraceptive implant, hormone- or antiviral releasing vaginal ring, oxytocin releasing microarray patch) and would not provide protection independently.

Polycystic Ovary Syndrome

Captured products include drugs, biologics, devices and combinations, and diagnostics, approved or under investigation for the prevention, treatment and detection of PCOS.

For inclusion in the pipeline dataset, medicine entries must:

• be drugs (small molecules intended for use in the cure, mitigation, treatment, or prevention of disease), biologics (animal or non-animal derived, immunoglobulins or non-immunoglobulin products) or devices and combinations (an instrument or appliance, either with or without a pharmacological element, intended to facilitate the delivery of a drug or biologic, prevent STI transmission or control uterine bleeding); with no restrictions: they can be entirely new entities; existing/repurposed or with label extensions; new formulations or dosing of existing/registered medicines.
• be preventive or therapeutic in nature – used to prevent or treat symptoms related to PCOS; this includes medicines targeting hyperandrogenism, metabolic regulation, fertility improvement and menstrual cycle regulation;
• have one or multiple indications related to polycystic ovarian syndrome;
• either be in active discovery, pre-clinical or clinical development since 2021, or be approved and registered for clinical use and/or be used currently in clinical treatment (off-label), and;
• be applicable for use in LMIC context.

For inclusion in the pipeline dataset, diagnostic entries must:

• be predictive/screening and/or diagnostic tests, with no restrictions: biochemical serum markers; non-biomarker tests; or fixed multiparametric tests;
• have an indication or multiple indications related to have one or multiple indications related to PCOS;
• either be in active discovery/pre-clinical or clinical development since 2021, or be approved and registered for clinical use and/or be used currently in clinical treatment (off-label), and;
• be applicable for use in LMIC context.

 Exclusions:

• Surgical interventions to treat or diagnose PCOS are excluded
• Dietary supplements are excluded
• Predictive/diagnostic strategies, algorithms with no identifiable products; or that include risk models that comprise of multiple individual parameters/tests as a single candidate entry (for example several individual biomarkers which diagnostic utility is evaluated separately and not as a combined test usable in the clinic);
• Clinical guidelines or criteria that are not a biomedical product are excluded.

Uterine fibroids

Captured products include drugs, biologics, devices and combinations, and diagnostics, approved or under investigation for the prevention, treatment and detection of uterine fibroids.

For inclusion in the pipeline dataset, medicine entries must:

• be drugs (small molecules intended for use in the cure, mitigation, treatment, or prevention of disease), biologics (animal or non-animal derived, immunoglobulins or non-immunoglobulin products) or devices and combinations (an instrument or appliance, either with or without a pharmacological element, intended to facilitate the delivery of a drug or biologic, prevent STI transmission or control uterine bleeding); with no restrictions: they can be entirely new entities; existing/repurposed or with label extensions; new formulations or dosing of existing/registered medicines.
• be preventive or therapeutic in nature – used to prevent or treat symptoms related to uterine fibroids; this includes medicines targeting menstrual cycle regulation, fibroid management (shrinking, prevention), and pain management;
• have one or multiple indications related to uterine fibroids;
• either be in active discovery/pre-clinical or clinical development since 2021, or be approved and registered for clinical use and/or be used currently in clinical treatment (off-label), and;
• be applicable for use in LMIC context.

For inclusion in the pipeline dataset, diagnostic entries must:

• be predictive/screening and/or diagnostic tests, with no restrictions: biochemical serum markers; non-biomarker tests; or fixed multiparametric tests;
• have an indication or multiple indications related to have one or multiple indications related to uterine fibroids;
• either be in active discovery, pre-clinical or clinical development since 2021, or be approved and registered for clinical use and/or be used currently in clinical treatment (off-label), and;
• be applicable for use in LMIC context.

Exclusions:

• Surgical interventions to treat or diagnose uterine fibroids are excluded;
• Dietary supplements, including vitamin-based therapies, are excluded;
• Predictive/diagnostic strategies, algorithms with no identifiable products; or that include risk models that comprise of multiple individual parameters/tests as a single candidate entry; (for example several individual biomarkers which diagnostic utility is evaluated separately and not as a combined test usable in the clinic);
• Clinical guidelines or criteria that are not a biomedical product are excluded.

The pipeline includes the following conditions and products: 

• Endometriosis: drugs, biologics, devices and combinations, and diagnostics
• PCOS: drugs, biologics, devices and combinations, and diagnostics
• Uterine fibroids: drugs, biologics, devices and combinations and diagnostics

All entries contain the same information. Data fields for each new candidate include all the following fields, where available and verifiable:

Table 2: Data fields

Data sources and approach

To build out comprehensive, candidate-driven pipeline datasets, we undertook a series of partially sequential, mutually reinforcing steps to build a picture of the candidates themselves, as well as the product development landscape for that SRH condition. Broadly (with more detail below), these steps are: (1) identify all candidates that are marketed or in development for each SRH health area and associated product type (e.g. Endometriosis diagnostics) and establish unique profiles for each with standardised classifications across a range of standard characteristics (2) gather information on that candidate’s clinical development and pre-clinical/clinical trial results, (3) research additional context around the product (e.g. development history, stakeholders, etc.), and (4) sense check our findings.

Step 1: Initial candidate and product identification

We utilised various sources to uncover, identify and cross-check candidates or marketed products. Key sources include:

• Adis Insight– a leading medicines development database, which will give a comprehensive output of relevant pipeline drugs, biologics (and possibly devices) related to relevant SRH conditions. Adis Insight also returns detailed information on candidate deals, trials, safety, patents, and other historical information.
• WHO International Clinical Trials Registry Platform (ICTRP) and ClinicalTrials.gov– the most comprehensive lists of global clinical trials available. Clinical trials will be scoped for relevance (defined as an investigation of one or more candidates or products with a primary and/or secondary outcome measure matching the scope). This step serves a dual function of uncovering additional candidates for inclusion, as well as capturing and linking clinical trial data to candidates marked for inclusion in the database (see Step 2 below for more information).
• EMBASE – for relevant product development literature to validate already identified and uncover new candidates for inclusion.
• Grant databases of relevant global funders of global health R&D – to validate existing and find new candidates (particularly those in preclinical/discovery stage). These include the United States National Institutes of Health (US NIH)’s RePORTER; the European Union/Commission’s CORDIS; the Gates Foundation (GF)’s grants database (supplied from the GF); SNSF, UKRI, and others as appropriate.
• Impact Global Health's G-FINDER R&D funding database for relevant projects. The SRH conditions covered in the pipeline have been included in the G-FINDER survey this year (2024) and the related grants will be included.

Step 2: Linking preclinical and clinical development data

Clinical trial data was collected via clinicaltrials.gov, WHO International Clinical Trials Registry Platform (ICTRP), and Adis Insight clinical trials outputs, linked to a diversity of clinical trial databases. We cross-checked interventions with the candidates identified in step 1, to provide more information on candidate clinical development. We cross-checked/follow up these outputs with relevant national clinical trials registers, as needed.

Step 3: Completing candidate and product profiles

Much of the candidate information needed to complete candidate profiles was provided through Steps 1 and 2. In addition, we utilised academic literature search engines to source greater detail and context for the candidates identified in Steps 1 and 2. Primarily, we searched EMBASE using the candidate name/s, and reviewed relevant literature retrieved (including that already sourced in Step 1) to verify and cross reference information as needed. Additional information was searched for via relevant regulatory websites, such as the US Food and Drug Administration (FDA) and European Medicines Agency (EMA) as appropriate, as well as a number of reliable online sources, including DRUGBANK Online, PubChem, the US National Library of Medicine’s Medical Subject Headings (MeSH) portal, and other websites as needed. Technical information on products was also sourced from developer websites and if applicable and available, product pamphlets/inserts.

Search terms & strategy for pipeline expansion

For most databases, we utilised variations and combinations of ‘condition’ related search words – such as ‘polycystic ovarian syndrome’ OR ‘PCOS’ etc – along with any timeframe filters to narrow down datasets for review.

These included the terms in Table 3 below.

Table 3: ‘Condition’ key words for SRH search queries

For very large datasets – such as /EMBASE – our search strategy was to link three to four keywords together, and query these in various/all possible combinations. This included the ‘condition’ key words (as above, e.g. ‘endometriosis’, ‘PCOS’, etc.), combined with those related to ‘product type’ (‘drug’, ‘biologic’, ‘diagnostic’, etc.), and to ‘research & development’ (‘innovation’, ‘discovery’, ‘preclinical’, ‘novel’, ‘clinical development’, etc.).

Ø  I.e.: ‘condition’ + ‘product type’ + ’R&D’

(e.g., ‘endometriosis’ + ‘drug’ + ‘novel’)

Table 4: 'Product type' and 'R&D' related key words for pipeline search queries