Endometriosis Clinical Trials and Studies 2025: EMA, PDMA, FDA Approvals, Mechanism of Action, ROA, NDA, IND, and Companies by DelveInsight

Endometriosis Clinical Trials and Studies 2025: EMA, PDMA, FDA Approvals, Mechanism of Action, ROA, NDA, IND, and Companies by DelveInsight

DelveInsight’s, “Endometriosis Pipeline Insight” report provides comprehensive insights about 15+ companies and 20+ pipeline drugs in Endometriosis pipeline landscape. It covers the pipeline drug profiles, including clinical and nonclinical stage products. It also covers the therapeutics assessment by product type, stage, route of administration, and molecule type. It further highlights the inactive pipeline products in this space.

 

Stay ahead with the latest insights! Download DelveInsight’s comprehensive Endometriosis Pipeline Report to explore emerging therapies, key players, and future treatment landscapes @ Endometriosis Pipeline Outlook Report

 

Key Takeaways from the Endometriosis Pipeline Report

  • In January 2025:- Organon and Co.- The purpose of this global Phase 2 study is to determine the efficacy, safety, and tolerability of 3 dose levels of OG-6219 in pre-menopausal women between 18 and 49 years of age (inclusive), who have moderate to severe endometriosis-related pain.
  • In January 2025:- AbbVie– A Phase 3b Study to Evaluate the Safety and Efficacy of Elagolix in Combination With Combined Oral Contraceptives in Premenopausal Women With Documented Endometriosis and Associated Moderate to Severe Pain.
  • DelveInsight’s Endometriosis pipeline report depicts a robust space with 15+ active players working to develop 20+ pipeline therapies for Endometriosis treatment.
  • The leading Endometriosis Companies such as ObsEva, Jiangsu HengRui Medicine Co., Ltd., Hope Medicine (Nanjing) Co., Ltd., ValiRx, BCI Pharma, Mithra Pharmaceuticals, Debiopharm, Forendo Pharma Ltd, TiumBio, EpicentRx, Flightpath Biosciences, Antev and others.
  • Promising Endometriosis Therapies such as Triptorelin Embonate, Implantable gestrinone, SN132D, OG-6219, Elagolix, and others.

 

Discover how the endometriosis treatment paradigm is evolving. Access DelveInsight’s in-depth Endometriosis Pipeline Analysis for a closer look at promising breakthroughs @ Endometriosis Clinical Trials and Studies

 

Endometriosis Emerging Drugs Profile

  • Linzagolix: ObsEva

ObsEva is currently advancing linzagolix, a novel, orally administered GnRH receptor antagonist with a potentially best-in-class profile in late-stage clinical development for the treatment of endometriosis-associated pain. Linzagolix acts by binding to and blocking the GnRH receptor in the pituitary gland, ultimately dose-dependently reducing estrogen production by the ovaries. Through previously reported results from linzagolix and sophisticated pharmacological modelling, it has been established that maintaining estradiol within a specific target range provides the optimal balance between reducing symptoms while mitigating bone density loss associated with excessive estradiol suppression.

 

  • HMI-115: Hope Medicine (Nanjing) Co., Ltd

HMI-115 is a first-in-class monoclonal antibody drug that Hope Medicine owns the global rights. In April 2019, Hope Medicine and Bayer AG signed an exclusive global license agreement for the development and commercialization of HMI-115, a monoclonal antibody targeting the prolactin receptor (PRLR), for multiple indications globally. Potential indications for the antibody include Endometriosis (EM), Androgenic Alopecia (AGA), and other chronic diseases. In 2021, Hope Medicine received approval from the FDA and EMA to conduct MRCT Phase II clinical trials for the treatment of endometriosis Hope Medicine has now completed patient enrollment and dosing at all clinical trial centers in the US and Europe.

 

  • VAL-301: ValiRx

VAL-301 is a small molecule, peptide, and new chemical entity it is developed in-house by ValiRx, under evaluation by an undisclosed Japanese Pharmaceutical Company. VAL301 peptide re-purposed towards non-cancerous cell proliferation. The mechanism of action of drug candidate is inhibition of androgen activation of SRC kinase. Currently, the drug is in preclinical stage of its development for the treatment of endometriosis.

 

Get a detailed analysis of the latest innovations in the endometriosis pipeline. Explore DelveInsight’s expert-driven report today! @ Endometriosis Unmet Needs

 

Endometriosis Companies

ObsEva, Jiangsu HengRui Medicine Co., Ltd., Hope Medicine (Nanjing) Co., Ltd., ValiRx, BCI Pharma, Mithra Pharmaceuticals, Debiopharm, Forendo Pharma Ltd, TiumBio, EpicentRx, Flightpath Biosciences, Antev and others.

 

Endometriosis pipeline report provides the therapeutic assessment of the pipeline drugs by the Route of Administration. Products have been categorized under various ROAs such as

  • Oral
  • Parenteral
  • Intravenous
  • Subcutaneous
  • Topical

 

Endometriosis Products have been categorized under various Molecule types such as

  • Monoclonal Antibody
  • Peptides
  • Polymer
  • Small molecule
  • Gene therapy

 

Download DelveInsight’s latest report to gain strategic insights into upcoming therapies and key developments @ Endometriosis Market Drivers and Barriers, and Future Perspectives

 

Scope of the Endometriosis Pipeline Report

  • Coverage- Global
  • Endometriosis Companies- ObsEva, Jiangsu HengRui Medicine Co., Ltd., Hope Medicine (Nanjing) Co., Ltd., ValiRx, BCI Pharma, Mithra Pharmaceuticals, Debiopharm, Forendo Pharma Ltd, TiumBio, EpicentRx, Flightpath Biosciences, Antev and others.
  • Endometriosis Therapies- Triptorelin Embonate, Implantable gestrinone, SN132D, OG-6219, Elagolix, and others.
  • Endometriosis Therapeutic Assessment by Product Type: Mono, Combination, Mono/Combination
  • Endometriosis Therapeutic Assessment by Clinical Stages: Discovery, Pre-clinical, Phase I, Phase II, Phase III

 

Which companies are leading the race in endometriosis drug development? Find out in DelveInsight’s exclusive Endometriosis Pipeline Report—access it now! @ Endometriosis Emerging Drugs and Major Companies

 

Table of Content

  1. Introduction
  2. Executive Summary
  3. Endometriosis: Overview
  4. Pipeline Therapeutics
  5. Therapeutic Assessment
  6. Endometriosis– DelveInsight’s Analytical Perspective
  7. Late Stage Products (Phase III)
  8. Linzagolix: ObsEva
  9. Drug profiles in the detailed report…..
  10. Mid Stage Products (Phase II)
  11. HMI-115: Hope Medicine (Nanjing) Co., Ltd
  12. Drug profiles in the detailed report…..
  13. Early Stage Products (Phase I/II)
  14. Drug Name: Company Name
  15. Drug profiles in the detailed report…..
  16. Preclinical and Discovery Stage Products
  17. VAL-301: ValiRx
  18. Drug profiles in the detailed report…..
  19. Inactive Products
  20. Endometriosis Key Companies
  21. Endometriosis Key Products
  22. Endometriosis- Unmet Needs
  23. Endometriosis- Market Drivers and Barriers
  24. Endometriosis- Future Perspectives and Conclusion
  25. Endometriosis Analyst Views
  26. Endometriosis Key Companies
  27. Appendix

 

About Us

DelveInsight is a leading healthcare-focused market research and consulting firm that provides clients with high-quality market intelligence and analysis to support informed business decisions. With a team of experienced industry experts and a deep understanding of the life sciences and healthcare sectors, we offer customized research solutions and insights to clients across the globe. Connect with us to get high-quality, accurate, and real-time intelligence to stay ahead of the growth curve.

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