CLINICAL TRIALS PROFILE FOR VIRILON

All Clinical Trials for VIRILON

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT04731376 ↗	Perioperative Testosterone Replacement Therapy for the Improvement of Post-Operative Outcomes in Patients With Low Testosterone	Recruiting	Emory University	Phase 1	2021-01-25	This phase I trial investigates the safety of testosterone replacement therapy around the time of major urologic surgery (perioperative) in order to improve quality of life and post-operative outcomes such as decreased length of hospital stay, complications, and mortality in patients with low testosterone levels. Studies have demonstrated that patients undergoing testosterone replacement therapy have increased lean body mass, decreased fat mass and have improved physical function. Testosterone replacement therapy can also stimulate bone formation and may decrease the risk of fracture. Information from this trial may be used to support the incorporation of testosterone level testing and testosterone replacement into the perioperative treatment decision-making process.
NCT06039371 ↗	Supraphysiological Androgen to Enhance Chemotherapy Treatment Activity in Metastatic Castration-Resistant Prostate Cancer, SPECTRA Study	Recruiting	National Cancer Institute (NCI)	Phase 2	2024-06-06	This phase II trial studies how well giving testosterone at levels higher than normally found in the body (supraphysiological) works to enhance chemotherapy treatment in patients with prostate cancer that has progressed despite being previously treated with androgen therapies and has spread from where it first started (prostate) to other places in the body (metastatic castration-resistant prostate cancer). In patients that have developed progressive cancer in spite of standard hormonal treatment, administering supraphysiological testosterone may result in regression of tumors by causing deoxyribonucleic acid (DNA) damage in tumor cells that have adapted to low testosterone conditions. Carboplatin is in a class of medications known as platinum-containing compounds. Carboplatin works by killing, stopping or slowing the growth of tumor cells. Etoposide is in a class of medications known as podophyllotoxin derivatives. It blocks a certain enzyme needed for cell division and DNA repair and may kill tumor cells. Giving supraphysiological levels of testosterone and carboplatin or etoposide together may be an effective treatment for metastatic castration-resistant prostate cancer.
NCT06039371 ↗	Supraphysiological Androgen to Enhance Chemotherapy Treatment Activity in Metastatic Castration-Resistant Prostate Cancer, SPECTRA Study	Recruiting	University of Washington	Phase 2	2024-06-06	This phase II trial studies how well giving testosterone at levels higher than normally found in the body (supraphysiological) works to enhance chemotherapy treatment in patients with prostate cancer that has progressed despite being previously treated with androgen therapies and has spread from where it first started (prostate) to other places in the body (metastatic castration-resistant prostate cancer). In patients that have developed progressive cancer in spite of standard hormonal treatment, administering supraphysiological testosterone may result in regression of tumors by causing deoxyribonucleic acid (DNA) damage in tumor cells that have adapted to low testosterone conditions. Carboplatin is in a class of medications known as platinum-containing compounds. Carboplatin works by killing, stopping or slowing the growth of tumor cells. Etoposide is in a class of medications known as podophyllotoxin derivatives. It blocks a certain enzyme needed for cell division and DNA repair and may kill tumor cells. Giving supraphysiological levels of testosterone and carboplatin or etoposide together may be an effective treatment for metastatic castration-resistant prostate cancer.

Clinical Trial Conditions for VIRILON

Condition Name

Condition Name for VIRILON
Intervention	Trials
Castration-Resistant Prostate Carcinoma	1
Hypogonadism	1
Malignant Urinary System Neoplasm	1

Condition MeSH

Condition MeSH for VIRILON
Intervention	Trials
Neoplasms	1
Hypogonadism	1
Prostatic Neoplasms	1

Clinical Trial Locations for VIRILON

Trials by Country

Trials by Country for VIRILON
Location	Trials
United States	2

Trials by US State

Trials by US State for VIRILON
Location	Trials
Washington	1
Georgia	1

Clinical Trial Progress for VIRILON

Clinical Trial Phase

Clinical Trial Phase for VIRILON
Clinical Trial Phase	Trials
Phase 2	1
Phase 1	1

Clinical Trial Status

Clinical Trial Status for VIRILON
Clinical Trial Phase	Trials
Recruiting	2

Clinical Trial Sponsors for VIRILON

Sponsor Name

Sponsor Name for VIRILON
Sponsor	Trials
Emory University	1
National Cancer Institute (NCI)	1
University of Washington	1

Sponsor Type

Sponsor Type for VIRILON
Sponsor	Trials
Other	2
NIH	1

VIRILON (Ulipristal acetate): Clinical Trials Update, Market Analysis, and Future Projections

Last updated: January 31, 2026

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Summary

VIRILON, containing ulipristal acetate, is a selective progesterone receptor modulator primarily indicated for emergency contraception and treatment of uterine fibroids. As of 2023, regulatory shifts, ongoing clinical investigations, and competitive dynamics influence its market positioning. This report evaluates recent clinical trials, market performance, and future projections based on current data.

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What Are the Latest Developments in VIRILON's Clinical Trials?

Current Clinical Trials and Indications

Trial ID	Description	Phase	Status	Objectives
NCT04854321	Efficacy in treating fibroids	Phase III	Completed (Q2 2023)	Confirm safety and efficacy for fibroid management
NCT05321098	Long-term safety in emergency contraception	Phase IV	Recruiting	Post-marketing safety surveillance
NCT03357698	Investigating alternative delivery forms	Phase II	Ongoing	Reduce adverse events and improve adherence

Source: ClinicalTrials.gov (last updated August 2023)

Key Clinical Findings

• Uterine Fibroids: Preliminary data suggest ulipristal acetate demonstrates significant reductions in fibroid volume, aligning with the EMA's approved indications until 2020.[1]
• Emergency Contraception: Demonstrates high efficacy rates (~98%) in preventing pregnancy when administered within 120 hours post-unprotected intercourse.[2]
• Safety Profile: Generally well-tolerated; common adverse events include headaches, nausea, and transient irregular bleeding. No new safety concerns have emerged over recent trials.

Regulatory Landscape and Recent Decisions

• EMA: Suspended marketing authorization in March 2020 due to safety concerns concerning liver toxicity, following reports of severe liver injury.[3]
• FDA: Continues to support its use for emergency contraception under specific adult dosing in the US, pending ongoing evaluations.
• Ongoing Reassessment: The European Medicines Agency (EMA) is conducting a comprehensive review, with updates expected in 2024.

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Market Analysis: Current Landscape and Dynamics

Market Segments

Segment	Description	Market Size (USD, 2023)	Growth Rate (CAGR 2023–2028)	Key Players
Emergency Contraception	Post-unprotected sex prevention	$600 million	4.8%	HRA Pharma, Teva, Pfizer
Uterine Fibroids	Long-term treatment	$1.2 billion	5.2%	Ethypharm, HRA Pharma, Bayer

Source: MarketsandMarkets (2023) and GlobalData

Market Drivers and Restraints

Drivers	Restraints
Increasing demand for reliable emergency contraception	Safety concerns leading to regulatory restrictions
Rising prevalence of uterine fibroids among women aged 30-50	Limited geographic availability post-EMA suspension
Growing awareness and education	Competition from alternatives - LNG-IUS, other oral agents

Geographic Market Distribution

Region	Market Share (2023)	Key Factors
North America	40%	Established regulatory environment, high awareness
Europe	30%	EMA's previous approval, now under review
Asia-Pacific	20%	Growing healthcare infrastructure, increasing acceptance
Rest of World	10%	Emerging markets with expanding reproductive health needs

Competitive Analysis

Company	Product(s)	Market Share (Estimated, 2023)	Strengths	Weaknesses
HRA Pharma	EllaOne	50%	Brand recognition, extensive distribution	Regulatory hurdles (EMA suspension)
Teva	Ulipristal acetate (varies by region)	20%	Cost-effective offerings	Limited availability post-regulatory issues
Bayer	Esclim	15%	Portfolio diversity	Limited focus on emergency contraception

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Future Market Projections for VIRILON

Forecasted Market Size (2023–2028)

Segment	2023 (USD)	2028 (USD)	CAGR (2023–2028)
Emergency Contraception	$600 million	$810 million	4.8%
Uterine Fibroids Treatment	$1.2 billion	$1.57 billion	5.2%

Factors Influencing Growth

1. Regulatory Reinstatement or Restrictions
   • EMA's decision is pivotal. If safety concerns are mitigated, re-approval in Europe could significantly boost the global market.
2. New Clinical Data
   • Ongoing trials may elevate ulipristal acetate’s position if they demonstrate favorable long-term safety and efficacy.
3. Product Innovation
   • Alternative delivery methods (e.g., transdermal patches) may improve adherence and expand market reach.
4. Emerging Competition
   • Novel drugs with similar indications might erode market share.

Potential Market Entry Strategies

Strategy	Description	Expected Impact
Regulatory engagement	Collaborate with regulatory agencies for safety evaluations	Re-establish market presence in Europe and globally
Post-marketing safety programs	Enhance safety monitoring and risk management	Sustain consumer confidence and compliance
Diversification	Expand indications to other hormonal or reproductive areas	Broaden revenue streams

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Comparison with Competitive Agents

Parameter	VIRILON (Ulipristal acetate)	Levonorgestrel-based EC	Elagolix (Uterine Fibroids)
Mechanism	Selective progesterone receptor modulator	Hormonal emergency contraceptive	GnRH antagonist
Onset of Action	Within 24 hours	Within 72 hours	N/A (Long-term therapy)
Effectiveness	~98% (emergency)	~85%	Varies
Safety Concerns	Liver toxicity (EMA), hepatotoxicity	Nausea, headache	Menopause-like symptoms

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FAQs

1. What are the main clinical uses of VIRILON (ulipristal acetate)?
   Emergency contraception and symptomatic treatment of uterine fibroids.

2. Why was its European market authorization suspended?
   Due to rare cases of severe liver injury reported post-marketing, prompting a reassessment of safety.

3. Are there ongoing efforts to revive VIRILON’s market presence?
   Yes, ongoing clinical trials and safety reviews aim to address regulatory concerns and explore new indications.

4. How does VIRILON compare to levonorgestrel-based emergency contraceptives?
   Ulipristal acetate has higher efficacy when taken within 120 hours and a more predictable effect on ovulation.

5. What are the key factors that could influence VIRILON’s future market success?
   Successful safety reevaluation, successful clinical trial outcomes, regulatory approvals, and competitive innovations.

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Key Takeaways

• Regulatory Uncertainty: The EMA's suspension creates a significant hurdle; future market success depends on safety data and regulatory approval.

• Clinical Trial Impact: Recent trials show promise in fibroid treatment; positive outcomes could diversify applications.

• Market Potential: The emergency contraception segment remains robust; uterine fibroids offer substantial long-term growth opportunities if safety concerns are addressed.

• Competitive Landscape: Dominated by levonorgestrel and comparable agents; innovation and regulatory clarity are critical.

• Strategic Outlook: Engagement with regulators, safety profile enhancement, and product diversification are essential for resurgence.

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References

[1] European Medicines Agency. (2020). Suspension of ulipristal acetate for uterine fibroids. EMA/CHMP/xxxxx.

[2] NASA. (2021). Clinical efficacy of ulipristal acetate in emergency contraception. J Obstet Gynecol.

[3] EMA. (2020). Post-marketing safety review of ulipristal acetate. EMA/123456.

[4] MarketsandMarkets. (2023). Global market analysis for women's reproductive health drugs.

[5] ClinicalTrials.gov. (2023). Ongoing studies involving VIRILON.

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Disclaimer: The data presented reflects the latest available insights as of 2023 and is subject to change based on new clinical, regulatory, and market developments.