Beyond Hormones: What It Will Take to Build a New Endometriosis Treatment Category

Boston, MA -- September 18 2026: For many people living with endometriosis, treatment options remain centered on hormonal therapies, pain medication and surgery.

Hormonal therapies help many women, but their effectiveness may be incomplete or temporary. Treatment can also involve trade-offs, including preventing conception during treatment, bone-density loss, mood effects and other consequences associated with endocrine suppression.

For patients who cannot tolerate hormonal therapies or do not want to use them, the remaining options are limited.

Ahead of Women's HealthX, we interviewed J.J. Marx, Chief Executive Officer at Foravisét, about the gaps in endometriosis care and what healthcare leaders should consider as non-hormonal approaches advance through clinical development.

Marx explains why non-hormonal treatment should be recognized as a distinct development frontier and what researchers, clinicians, regulators and payers will need to consider as the field evolves.

The central gap is the absence of an effective treatment that does not require hormonal intervention. Addressing that gap will require more than applying a new label to drug development.

Healthcare leaders must support the research, clinical-trial designs and evidence standards required to establish non-hormonal treatment as a genuine therapeutic category.

This also requires a broader understanding of the biology of endometriosis.

Research indicates that endometriosis should not be reduced to a hormonal disorder. The disease involves chronic inflammation, abnormal immune activity, pain signaling, tissue injury, fibrosis and adhesions.

Hormonal suppression can influence symptoms and disease activity, but it does so by interfering with normal endocrine function. As Professor Hugh Taylor of Yale has described it, the current approach can involve "messing up a healthy system to resolve another."

The emerging opportunity is to target the inflammatory and tissue-level processes involved in endometriosis more directly, without suppressing the natural menstrual cycle.

This could potentially provide more immediate symptom relief. The longer-term objective is more ambitious: determining whether treatment can affect the evolution of the disease itself, including the processes that contribute to progressive tissue damage, fibrosis and adhesions.

Any clinically meaningful treatment will also need to demonstrate value beyond pain reduction.

Researchers should examine how quickly a benefit appears, how it changes over time and whether it reduces the need for rescue medication. Quality of life, daily function, bleeding and other symptoms should also form part of the assessment.

Hormonal suppression generally takes time to become effective and may require a recovery period after treatment is discontinued. A non-hormonal treatment could potentially offer a more immediate and flexible efficacy profile, but this must be demonstrated through clinical evidence.

Evaluation should also account for the broader burdens associated with hormonal treatment. These can include monitoring and medication required to manage bone-density loss with certain therapies, as well as mood effects and other adverse consequences of endocrine intervention.

Fertility preservation is another important longer-term objective. However, demonstrating an effect on fertility will require studies specifically designed to assess that outcome later in development.

Measuring these outcomes presents a specific challenge when a treatment preserves the natural menstrual cycle.

Established hormonal-treatment trials provide important benchmarks for endpoints including dysmenorrhea, non-menstrual pelvic pain, rescue-medication use and quality of life. Non-hormonal trials should retain sufficiently comparable measures so clinicians, regulators and payers can interpret the evidence against the existing standard.

The endpoints themselves are not new. The difference lies in how the underlying treatment effect may develop.

When the natural menstrual cycle is preserved, symptoms continue to fluctuate throughout the cycle. Efficacy cannot be inferred from menstrual suppression or induced amenorrhea.

Trials must therefore capture how soon improvement occurs after treatment begins and how that improvement evolves across successive menstrual cycles.

The objective is to use recognized clinical benchmarks while adapting the timing and interpretation of assessments to reflect the distinctive characteristics of a cycle-preserving therapy.

Alongside clinical development, emerging biopharma companies must also consider how evidence will be interpreted by healthcare decision-makers.

Health economics should be incorporated into the clinical development plan as early as possible. This is particularly important for non-hormonal endometriosis therapies because there is currently little precedent for how payers will assess their additional value.

Hormonal therapies provide the most obvious comparators, but they may not capture the complete clinical, economic and quality-of-life value of avoiding hormone-related burdens.

On the eve of its Phase IIa study, Foravisét is beginning ground-level research with payers to understand what evidence will be required to support reimbursement.

This includes determining which clinical, economic and quality-of-life outcomes will be most meaningful to decision-makers, how the avoidance of hormone-related burdens will be valued and what population evidence will be needed.

That evidence strategy will also be important for equitable access. The goal should be to prevent access from becoming limited to narrowly selected patient groups and ensure that the evidence reflects the broader population that may benefit from additional treatment options.

Establishing non-hormonal treatment as a genuine therapeutic category will require coordination across the healthcare ecosystem. Researchers must investigate the wider biology of endometriosis. Clinical trials must measure outcomes that matter to patients while producing evidence that regulators, clinicians and payers can interpret. Biopharma companies must begin planning for access and reimbursement before late-stage development.

Most importantly, progress must be defined by what patients no longer have to sacrifice to obtain relief.