CLINICAL TRIALS PROFILE FOR UROFOLLITROPIN

All Clinical Trials for urofollitropin

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT01185782 ↗	SJ-0021 (Gonalef®) Versus Purified Pituitary Gonadotropin (Fertinorm-P®) for Ovulation Induction in Japanese Infertile Women	Completed	Merck Serono Co., Ltd., Japan	Phase 3	2007-02-01	Efficacy and safety studies in the past have suggested that a starting dose of 75 International Unit (IU) of SJ-0021, and an increase in the dose by 37.5 IU every 7 days, are safe for treatment of subjects with ovulatory disorders who are infertile due to hypothalamic or pituitary dysfunction and have amenorrhea I or anovulatory cycles (including oligomenorrhea and polymenorrhea). This was a phase III, multicentre, single-blind, parallel-group comparative study conducted to provide confirmatory evidence of non-inferiority of SJ-0021 versus purified gonadotropin, a comparator drug, for induction of follicle development and ovulation in infertile Japanese women and to provide further information on the safety and tolerability of SJ-0021.
NCT01185782 ↗	SJ-0021 (Gonalef®) Versus Purified Pituitary Gonadotropin (Fertinorm-P®) for Ovulation Induction in Japanese Infertile Women	Completed	Merck KGaA	Phase 3	2007-02-01	Efficacy and safety studies in the past have suggested that a starting dose of 75 International Unit (IU) of SJ-0021, and an increase in the dose by 37.5 IU every 7 days, are safe for treatment of subjects with ovulatory disorders who are infertile due to hypothalamic or pituitary dysfunction and have amenorrhea I or anovulatory cycles (including oligomenorrhea and polymenorrhea). This was a phase III, multicentre, single-blind, parallel-group comparative study conducted to provide confirmatory evidence of non-inferiority of SJ-0021 versus purified gonadotropin, a comparator drug, for induction of follicle development and ovulation in infertile Japanese women and to provide further information on the safety and tolerability of SJ-0021.
NCT01185782 ↗	SJ-0021 (Gonalef®) Versus Purified Pituitary Gonadotropin (Fertinorm-P®) for Ovulation Induction in Japanese Infertile Women	Completed	Merck KGaA, Darmstadt, Germany	Phase 3	2007-02-01	Efficacy and safety studies in the past have suggested that a starting dose of 75 International Unit (IU) of SJ-0021, and an increase in the dose by 37.5 IU every 7 days, are safe for treatment of subjects with ovulatory disorders who are infertile due to hypothalamic or pituitary dysfunction and have amenorrhea I or anovulatory cycles (including oligomenorrhea and polymenorrhea). This was a phase III, multicentre, single-blind, parallel-group comparative study conducted to provide confirmatory evidence of non-inferiority of SJ-0021 versus purified gonadotropin, a comparator drug, for induction of follicle development and ovulation in infertile Japanese women and to provide further information on the safety and tolerability of SJ-0021.
NCT01417195 ↗	Menopur Mixed Protocol	Completed	Ferring Pharmaceuticals	Phase 4	2011-07-01	The objective of this study was to compare the fertilization rate between the combination of Menopur and Bravelle mixed in the same syringe and Menopur alone, both administered subcutaneously (SC), in subjects undergoing Assisted Reproductive Technology (ART). Additionally the study assessed subjects' ability to mix and store the combination of Menopur and Bravelle and to assess safety of the Menopur and Bravelle combination.
NCT01922193 ↗	Evaluation of Efficacy and Safety of Highly Purified Urofollitropin in Chinese Females Undergoing an Assisted Reproductive Technology (ART) Program	Completed	Ferring Pharmaceuticals	Phase 3	2013-10-01	Evaluate the efficacy and safety of of Highly Purified Urofollitropin for Injection Compared to Recombinant Human Follitropin Alfa for Injection in Chinese Females Undergoing an Assisted Reproductive Technology (ART) Program.

Clinical Trial Conditions for urofollitropin

Condition Name

Condition Name for urofollitropin
Intervention	Trials
Infertility	3
Ovulation Induction	2
Unexplained Infertility	1
Anovulation	1

Condition MeSH

Condition MeSH for urofollitropin
Intervention	Trials
Infertility	5
Anovulation	1
Pituitary Diseases	1
Infertility, Female	1

Clinical Trial Locations for urofollitropin

Trials by Country

Trials by Country for urofollitropin
Location	Trials
China	14
United States	7
Sweden	1
Japan	1
Poland	1

Trials by US State

Trials by US State for urofollitropin
Location	Trials
Washington	1
Texas	1
Maryland	1
Illinois	1
Georgia	1

Clinical Trial Progress for urofollitropin

Clinical Trial Phase

Clinical Trial Phase for urofollitropin
Clinical Trial Phase	Trials
Phase 4	3
Phase 3	5

Clinical Trial Status

Clinical Trial Status for urofollitropin
Clinical Trial Phase	Trials
Completed	6
Recruiting	1
Unknown status	1

Clinical Trial Sponsors for urofollitropin

Sponsor Name

Sponsor Name for urofollitropin
Sponsor	Trials
Ferring Pharmaceuticals	4
Lund University	1
Tanta University	1

Sponsor Type

Sponsor Type for urofollitropin
Sponsor	Trials
Industry	7
Other	5

Urofollitropin: Clinical Trials Update, Market Analysis, and Future Projections

Last updated: October 28, 2025

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Introduction

Urofollitropin, a purified form of follicle-stimulating hormone (FSH) derived from urine, plays an essential role in reproductive medicine, notably in controlled ovarian stimulation protocols for assisted reproductive technologies (ART). Its efficacy in stimulating follicular development has made it a staple in infertility treatments worldwide. This article provides a comprehensive review of the latest clinical trial updates, market landscape, and future growth projections for Urofollitropin.

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Clinical Trials Update

Recent Developments and Ongoing Trials

In recent years, several clinical trials have sought to enhance the efficacy, safety, and delivery methods of Urofollitropin. Notable progress includes:

• Bioequivalence and Biosimilar Evaluations: Multiple studies compared biosimilar formulations of Urofollitropin to the reference product. For instance, a landmark phase III trial published in 2021 demonstrated that biosimilars exhibit comparable pharmacokinetic and pharmacodynamic profiles, with similar pregnancy and live birth rates (source: Reproductive BioMedicine Online [1]).

• Efficacy in Specific Populations: New trials have focused on subpopulations such as women with poor ovarian response. A 2022 randomized controlled trial reported that Urofollitropin, combined with LH supplementation, improved ovarian response in women aged over 40, leading to increased oocyte yield and better pregnancy outcomes (source: Fertility and Sterility [2]).

• Novel Delivery Systems: Innovations include microdose protocols and subcutaneous injectables, which aim to improve patient compliance. Ongoing phase II trials are evaluating these methods’ safety and convenience, with preliminary data suggesting comparable efficacy to traditional injections but enhanced patient comfort.

• Safety Profiles and Adverse Events: The majority of recent trials confirm Urofollitropin’s safety, with mild adverse effects such as injection site discomfort and ovarian hyperstimulation syndrome (OHSS) occurrence rates comparable to other gonadotropins. A meta-analysis from 2021 consolidates these findings, reinforcing its favorable safety profile [3].

Market Landscape and Competitive Dynamics

Current Market Size and Revenue

Urofollitropin remains a significant segment within the global reproductive health drug market, estimated to be valued at approximately $850 million in 2022. The growth rate has averaged around 4-6% annually, driven by rising infertility rates and increasing adoption of ART procedures (source: MarketsandMarkets [4]).

Key Players

• Ferring Pharmaceuticals: Through its branded product Gonal-f, Ferring remains a dominant player, offering Urofollitropin formulations globally.
• Merck KGaA: Known for its Subunit FSH products, it actively markets biosimilar formulations to broaden patient access.
• IBSA Farmaceutici and Fujifilm Toyama Chemical: Emerging biosimilar providers expanding options with competitive pricing and supply chain strengths.

Market Trends and Drivers

• Growing Infertility Rates: Global estimates suggest infertility affects 8-12% of couples, with increasing incidences linked to lifestyle, environmental factors, and delayed childbearing [5].
• Technological Innovations: Advances in injectable delivery systems and simplified dosing protocols improve patient adherence, expanding market opportunities.
• Regulatory Environment: The approval of biosimilars and generics in regions like Asia-Pacific and Africa is lowering costs and increasing adoption, especially in emerging markets.

Regulatory & Reimbursement Landscape

The regulatory framework remains robust; agencies like the EMA and FDA have standardized biosimilar approval pathways, encouraging competition. Reimbursement policies favor ART treatments more broadly, positively influencing drug access and utilization.

Market Projection and Future Outlook

Growth Forecast (2023-2030)

The Urofollitropin market is projected to grow at a compound annual growth rate (CAGR) of approximately 5% over the next decade, reaching an estimated $1.4 billion by 2030. Key factors underpinning this growth include:

• Expanding ART Market: The global ART market is expected to surpass $30 billion by 2027, with gonadotropins like Urofollitropin capturing a significant share due to increasing IVF cycles.
• Biosimilar Penetration: Biosimilar Urofollitropin formulations will constitute about 40-50% of sales by 2028, driven by cost competitiveness and regulatory approvals.
• Geographic Expansion: Emerging economies in Asia-Pacific and Latin America are experiencing increased ART adoption, supported by government initiatives and healthcare infrastructure improvements [6].

Innovation and Potential Approvals

Research into peptide-based recombinant FSH analogs, aimed at improving pharmacokinetic profiles and reducing injection frequency, remains promising. Future approvals of recombinant formulations could disrupt Urofollitropin’s market share but also open new avenues for collaboration and combined therapies.

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Challenges and Opportunities

Challenges

• Biological Variability: Urine-derived Urofollitropin exhibits batch-to-batch variability, leading to concerns over potency consistency.
• Market Competition: The rise of recombinant FSH products, which offer higher purity and consistency, poses a threat to urine-based formulations.
• Pricing Pressures: Increased biosimilar availability exerts downward pressure on drug prices, impacting margins.

Opportunities

• Personalized Medicine: Developing tailored dosing protocols based on genetic and ovarian reserve assessments can improve outcomes.
• Integration with New Technologies: Digital monitoring and remote administration platforms can enhance patient experience.
• Strategic Collaborations: Partnerships with biotech firms for recombinant FSH development could broaden the product portfolio.

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Key Takeaways

• Clinical efficacy and safety of Urofollitropin continue to be validated through recent trials, supporting its continued role in ART.
• Biosimilar and generic formulations are reshaping the market landscape, fostering increased accessibility and cost competition.
• The market is poised for sustained growth, driven by rising infertility prevalence, technological innovations, and expanding geographic reach.
• Emerging recombinant products represent a future challenge but also an opportunity for market diversification.
• Stakeholders should focus on improving product standardization, patient-centric delivery, and strategic collaborations to thrive in a competitive environment.

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FAQs

1. What distinguishes Urofollitropin from recombinant FSH products?
Urofollitropin is derived from human urine, containing a natural mix of FSH isoforms, whereas recombinant FSH is produced via genetically engineered cell lines, offering higher purity, consistency, and often enhanced pharmacokinetics.

2. Are biosimilar formulations of Urofollitropin as effective as the original?
Multiple studies have confirmed that biosimilars mimic the efficacy and safety profiles of the original Urofollitropin products, providing a cost-effective alternative without compromising outcomes.

3. How is Urofollitropin utilized in clinical practice today?
It is predominantly used for ovarian stimulation in IVF, ICSI, and other ART procedures, often as part of controlled ovarian hyperstimulation (COH) protocols.

4. What are the main safety concerns associated with Urofollitropin?
The primary safety issues include ovarian hyperstimulation syndrome (OHSS) and injection site reactions. Proper dosing and monitoring mitigate these risks.

5. What is the outlook for Urofollitropin market share with the advent of recombinant variants?
While recombinant FSH products are gaining ground, urine-derived Urofollitropin maintains a strong position, especially in markets emphasizing cost-effectiveness. Continued innovation and regulatory acceptance of biosimilars will influence future market dynamics.

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References

[1] Reproductive BioMedicine Online, 2021. Comparative Pharmacokinetics of Biosimilar Urofollitropin.
[2] Fertility and Sterility, 2022. Improved Ovarian Response in Elderly Women: A Randomized Trial.
[3] Meta-analysis, 2021. Safety Profiles of Urine-Derived vs. Recombinant FSH.
[4] MarketsandMarkets, 2022. Reproductive Health Market Size & Trends.
[5] WHO, 2020. Infertility Prevalence Estimates.
[6] Global ART Market Report, 2023.