Endometriosis Pipeline

DelveInsight’s, “Endometriosis - Pipeline Insight, 2025” report provides comprehensive insights about 18+ 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.

 

Geography Covered

• Global coverage

 

Endometriosis: Understanding

Endometriosis: Overview

Endometriosis is characterized by the growth of endometrial-like glands and stroma outside the uterus. These lesions may appear as peritoneal deposits, superficial ovarian implants or cysts, or as deep infiltrating disease. Although its exact cause remains unclear, several theories have been proposed to explain the development of endometriotic lesions. One widely discussed mechanism is retrograde menstruation, observed in women and certain non-human primates, where menstrual blood flows backward through the fallopian tubes into the pelvic cavity. This backward flow, together with possible spread via the blood or lymphatic system, can lead to the implantation of endometrial tissue in abnormal locations.

The absence of a universally accepted staging system remains a challenge in endometriosis management, as consistent classification is essential for clear physician communication and standardized treatment strategies. Since Sampson’s initial categorization of ovarian hematomas in 1921, multiple systems have been proposed, but none are considered fully optimal due to the complex and variable nature of the disease and its unclear correlation with symptom severity. Currently, four main classification systems are used: the revised American Society for Reproductive Medicine (rASRM) classification, ENZIAN classification, Endometriosis Fertility Index (EFI), and American Association of Gynecological Laparoscopists (AAGL) classification.

Endometriosis presents with a wide range of symptoms that significantly impair quality of life, often beginning before age 20 in most women. Common manifestations include severe premenstrual and pelvic pain, dysmenorrhea, painful ovulation, pain during intercourse, defecation, or urination, abnormal bleeding, gastrointestinal disturbances, infertility, and chronic fatigue. Additional symptoms may include nausea, headaches, dizziness, depression, anxiety, and urinary or rectal bleeding during menstruation. Pain typically starts before menstruation, intensifies over time, and may persist throughout the cycle, often radiating to the sacral or pelvic regions. Interestingly, advanced disease may be asymptomatic, while minor lesions can cause severe pain. Adhesions, fallopian tube involvement, and immune responses against the endometrium can contribute to infertility and pregnancy loss. In adenomyosis, heavy and prolonged menstruation is also a common feature.

Endometriosis risk is shaped by reproductive, hormonal, and lifestyle factors. Early menarche, short cycles, and nulliparity raise risk, while parity and current oral contraceptive use are generally protective, though evidence is mixed. Lower BMI and smoking may reduce risk via lower estrogen levels, but findings are inconsistent. Alcohol and caffeine may increase risk in infertile women, whereas omega-3 fatty acids and anti-inflammatory diets may offer protection; physical activity shows unclear effects. Research is limited by reliance on surgical diagnosis, underscoring the need for large, modern cohorts to validate risk factors, guide targeted screening, and inform new diagnostic and therapeutic approaches.

Endometriosis remains a poorly understood disease, with its exact cause still unknown. First termed by J.A. Sampson in 1927, the condition is most commonly explained by his theory of retrograde menstruation, where menstrual blood flows backward, allowing endometrial cells to implant in the peritoneal cavity. While numerous alternative hypotheses have emerged over the years, Sampson’s theory remains the most widely accepted. However, it does not fully explain why retrograde menstruation, which occurs in nearly 90% of women, only results in endometriosis in a minority of cases.

Endometriosis cannot be reliably diagnosed with blood tests, and while laparoscopy with histopathology was once the gold standard, current guidelines favor a clinical diagnosis based on symptoms, examination, and imaging to reduce delays and surgical risks. Common indicators include dysmenorrhea, dyspareunia, pelvic pain, menorrhagia, and subfertility. Pelvic exam findings may suggest disease, but imaging especially transvaginal ultrasound and MRI are the key for detecting endometriomas and deep endometriosis, though superficial lesions remain hard to identify. This clinical approach allows earlier treatment, validates patient symptoms, and helps prevent long-term complications.

Endometriosis treatment involves a multidisciplinary approach using surgery, hormonal therapy, and pain management. First-line options include NSAIDs and combined oral contraceptives, while second-line therapies such as progestins, GnRH agonists/antagonists with add-back therapy, and aromatase inhibitors are reserved for more severe cases. Surgery, including excision of implants or hysterectomy with bilateral salpingo-oophorectomy, can improve pain and fertility but carries risks of recurrence and reduced ovarian reserve, making careful patient selection essential. For infertility, surgery may increase natural conception rates but should be balanced against assisted reproductive technologies.

"Endometriosis- Pipeline Insight, 2025" report by DelveInsight outlays comprehensive insights of present scenario and growth prospects across the indication. A detailed picture of the Endometriosis pipeline landscape is provided which includes the disease overview and Endometriosis treatment guidelines. The assessment part of the report embraces, in depth Endometriosis commercial assessment and clinical assessment of the pipeline products under development. In the report, detailed description of the drug is given which includes mechanism of action of the drug, clinical studies, NDA approvals (if any), and product development activities comprising the technology, Endometriosis collaborations, licensing, mergers and acquisition, funding, designations and other product related details.

 

Report Highlights

• The companies and academics are working to assess challenges and seek opportunities that could influence Endometriosis R&D. The therapies under development are focused on novel approaches to treat/improve Endometriosis.

 

Endometriosis Emerging Drugs Chapters

This segment of the Endometriosis report encloses its detailed analysis of various drugs in different stages of clinical development, including Phase III, II, I, Preclinical and Discovery. It also helps to understand clinical trial details, expressive pharmacological action, agreements and collaborations, and the latest news and press releases.

 

Endometriosis Emerging Drugs

• Estelle: Gedeon Ritcher

Estelle is Mithra’s first E4-based product, containing 15 mg Estetrol (E4) and 3 mg Drospirenone (DRSP). Estetrol, a natural estrogen produced by the human fetus during pregnancy, enters maternal circulation at relatively high levels. Its unique mechanism of action and favorable safety profile position Estetrol as a potential breakthrough in women’s health and other therapeutic areas. As the first native estrogen of fetal origin, E4 selectively targets estrogen receptors, a property expected to offer multiple benefits for patients. Currently the drug is in Phase III stage of its development for the treatment of Endometriosis.

 

• GenSci048: Changchun GeneScience Pharmaceutical Co., Ltd.

GenSci048, developed by Changchun GeneScience Pharmaceutical Co., Ltd., is an investigational subcutaneous therapy administered every four weeks for moderate to severe endometriosis-related pain. Currently entering Phase IIa, the agent is being evaluated for its effectiveness in alleviating dysmenorrhea and pelvic pain, along with its safety profile. The study is a randomized, double-blind, placebo-controlled trial, with primary outcomes assessing pain reduction on a numeric rating scale over 24 weeks. This development underscores GenSci’s commitment to advancing innovative solutions for women’s health and addressing unmet needs in gynecological care. Currently, the drug is in the Phase II stage of its development for the treatment of Endometriosis.

 

• NP137P: NETRIS Pharma

NP137P is a humanized IgG1 monoclonal antibody that targets netrin‑1, a key factor in epithelial-to-mesenchymal transition (EMT) and lesion progression. In preclinical endometriosis models, anti‑netrin‑1 treatment notably reduced lesion size and pain, establishing NP137P as the first non-hormonal, disease-modifying biologic candidate for this condition. The drug is currently being evaluated in Preclinical stage of its development for the treatment of Endometriosis.

 Further product details are provided in the report……..

 

Endometriosis: Therapeutic Assessment

This segment of the report provides insights about the different Endometriosis drugs segregated based on following parameters that define the scope of the report, such as:

 

Major  Players in Endometriosis

• There are approx. 18+ key companies which are developing the therapies for Endometriosis. The companies which have their Endometriosis drug candidates in the most advanced stage, i.e. Phase III include, Gedeon Ritcher.

 

Phases

DelveInsight’s report covers around 20+ products under different phases of clinical development like

• Late stage products (Phase III)
• Mid-stage products (Phase II)
• Early-stage product (Phase I) along with the details of
• Pre-clinical and Discovery stage candidates
• Discontinued & Inactive candidates

 

Route of Administration

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
• Intravenous
• Subcutaneous
• Parenteral
• Topical

 

Molecule Type

Products have been categorized under various Molecule types such as

• Recombinant fusion proteins
• Small molecule
• Monoclonal antibody
• Peptide
• Polymer
• Gene therapy

 

Product Type

Drugs have been categorized under various product types like Mono, Combination and Mono/Combination.

 

Endometriosis: Pipeline Development Activities

The report provides insights into different therapeutic candidates in Phase III, II, I, preclinical and discovery stage. It also analyses Endometriosis therapeutic drugs key players involved in developing key drugs.

 

Pipeline Development Activities

The report covers the detailed information of collaborations, acquisition and merger, licensing along with a thorough therapeutic assessment of emerging Endometriosis drugs.

 

Endometriosis Report Insights

• Endometriosis Pipeline Analysis
• Therapeutic Assessment
• Unmet Needs
• Impact of Drugs

 

Endometriosis Report Assessment

• Pipeline Product Profiles
• Therapeutic Assessment
• Pipeline Assessment
• Inactive drugs assessment
• Unmet Needs

 

Key Questions

Current Treatment Scenario and Emerging Therapies:

• How many companies are developing Endometriosis drugs?
• How many Endometriosis drugs are developed by each company?
• How many emerging drugs are in mid-stage, and late-stage of development for the treatment of Endometriosis?
• What are the key collaborations (Industry–Industry, Industry–Academia), Mergers and acquisitions, licensing activities related to the Endometriosis therapeutics?
• What are the recent trends, drug types and novel technologies developed to overcome the limitation of existing therapies?
• What are the clinical studies going on for Endometriosis and their status?
• What are the key designations that have been granted to the emerging drugs?