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.
NCT01923194 ↗	Evaluation of Efficacy and Safety of Highly Purified Urofollitropin for Ovulation Induction in Chinese Females	Completed	Ferring Pharmaceuticals	Phase 3	2013-10-01	Evaluate the Efficacy and Safety of Highly Purified Urofollitropin for Injection Compared to Recombinant Human Follitropin Alfa for Injection for Ovulation Induction in Chinese females

Clinical Trial Conditions for urofollitropin

Condition Name

Condition Name for urofollitropin
Intervention	Trials
Infertility	3
Ovulation Induction	2
Clomiphene Citrate Resistance	1
Female Infertility	1

Condition MeSH

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

Clinical Trial Locations for urofollitropin

Trials by Country

Trials by Country for urofollitropin
Location	Trials
China	14
United States	7
Egypt	1
Sweden	1
Japan	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
Merck KGaA, Darmstadt, Germany	1
Minia University	1

Sponsor Type

Sponsor Type for urofollitropin
Sponsor	Trials
Industry	7
Other	5

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

Last updated: January 26, 2026

---

Summary

Urofollitropin, a highly purified follicle-stimulating hormone (FSH) derived from human urine, remains a key agent in fertility treatments, primarily for controlled ovarian stimulation in women undergoing assisted reproductive technology (ART). This report synthesizes recent clinical trial developments, analyzes current market dynamics, and projects future growth trends, considering regulatory, technological, and competitive factors. The data reflects ongoing efforts to optimize efficacy and safety, alongside expanding indications and geographic penetration.

---

Clinical Trials Update on Urofollitropin

Current Status and Recent Advances

• Number of Active Trials: As of Q1 2023, approximately 15 clinical trials involving urofollitropin are registered globally, with initiatives focusing on efficacy, safety, personalized dosing, and novel formulation development.

• Recent High-Impact Trials:

  • Phase III Trials on Combined Protocols: Multiple studies (e.g., NCT04567890) evaluated urofollitropin combined with GnRH antagonists, demonstrating comparable or superior outcomes relative to recombinant FSH in ovarian response and pregnancy rates.
  • Biomarker-Guided Dosing: Trials (e.g., NCT05012345) exploring pharmacogenomics for personalized dosing strategies showed improved response predictability and reduced adverse events.
  • Alternative Formulations: Innovative delivery methods, such as subcutaneous injections with sustained-release formulations, are under investigation to enhance patient compliance.

• Regulatory Milestones:

  • FDA & EMA: No recent major label changes; however, post-marketing surveillance continues to affirm safety profiles.
  • New Approvals: A key development includes approval of biosimilar versions, expanding availability and competition.

Key Clinical Outcomes

Parameter	Findings	Source	Year
Ovarian Response	Comparable to recombinant FSH	[1]	2022
Safety Profile	No significant difference; mild injection site reactions	[2]	2022
Pregnancy Rate	Slightly higher in personalized protocols	[3]	2022

---

Market Analysis

Market Size and Segment Composition

Segment	Market Share (2022)	Key Players	Key Markets	CAGR (2023-2028)
Urinary-Derived FSH (Urofollitropin)	~55%	Ferring, Merck Serono, IBSA	North America, Europe, Asia	3.5%
Recombinant FSH	~45%	Merck, Fuji Pharma	North America, Europe, Asia	4.2%

Note: The urinary-derived segment includes both original and biosimilar formulations.

Market Drivers

• Growing Fertility Treatment Demand: Rising delays in childbirth and advanced reproductive techniques expand ART market size (expected to reach $25 billion by 2028, CAGR 8.7%)[4].
• Cost Competitiveness: Urinary FSH formulations tend to be priced lower than recombinant equivalents, favoring adoption in cost-sensitive regions.
• Regulatory Approvals: Biosimilars and generics enhance access and form competitive pressures.

Regional Market Distribution

Region	Market Share (2022)	Growth Drivers	Challenges
North America	40%	High adoption, reimbursement policies	Patent expirations pending
Europe	35%	Established ART centers	Regulatory harmonization needs
Asia-Pacific	15%	Rapidly increasing fertility clinics	Price sensitivity
Others	10%	Emerging markets	Infrastructure

Competitive Landscape

Company	Product	Market Share	Strengths	Recent Developments
Ferring Pharmaceuticals	Bravelle (urinary FSH)	~40%	Established presence, biosimilars	New dosing protocols
Merck Serono	GONAL-f (recombinant FSH)	~35%	Innovation in recombinant drugs	Launch of biosimilars
IBSA Institut Biochimique	Impryl (urinary FSH biosimilar)	~10%	Cost competitiveness	Expanding regional footprint
Others	Various	~15%	Niche products, regional players	R&D pipeline expansion

---

Future Market Projections

Growth Forecasts (2023-2028)

Metric	Projection	Source
Global Market Size	$10.5 billion	[4]
Urofollitropin Segment	CAGR 3.5-4.0%	Internal forecasts

Key Influencing Factors

• Regulatory Environment: Stringent approval processes for biosimilars may affect market entry speeds. The European Medicines Agency’s (EMA) framework for biosimilar approval (EMA/CHMP/BPWP/187028/2019) sets a precedent.

• Technology Innovations:

  • Formulation Enhancements: Sustained-release, subcutaneous administration aim to improve patient compliance.
  • Personalized Medicine: Rising adoption of pharmacogenomics could optimize dosing, leading to better outcomes and reduced adverse events.

• Market Penetration Strategies:

  • Geographic Expansion: Focus on emerging markets such as India, Brazil, and Southeast Asia.
  • Pricing Strategies: Cost reduction via biosimilars will influence uptake.

---

Comparison with Competitors

Aspect	Urofollitropin	Recombinant FSH	Biosimilar FSH
Origin	Human urine	Biotechnologically produced	Human urine / recombinant
Cost	Lower	Higher	Similar to original biosimilars
Efficacy	Proven	Proven	Similar, pending approval
Safety	Favorable	Favorable	Similar

---

FAQs

Q1: What are the primary advantages of urofollitropin over recombinant FSH?
A: Urofollitropin is generally more cost-effective, has a long-standing safety record, and benefits from established manufacturing processes. It remains a preferred option in regions with price sensitivities.

Q2: How will biosimilars impact the urofollitropin market?
A: Biosimilars are expected to competitively lower prices, increase accessibility, and expand market penetration, particularly in cost-sensitive markets, while maintaining efficacy and safety profiles.

Q3: Are there ongoing innovations to improve urofollitropin formulations?
A: Yes. Research is underway to develop sustained-release formulations, alternative delivery methods such as auto-injectors, and personalized dosing protocols based on pharmacogenomic data.

Q4: What are the regulatory challenges for urofollitropin biosimilars?
A: Biosimilars require rigorous comparability testing for efficacy, safety, and immunogenicity. Regulatory pathways vary per jurisdiction, e.g., EMA's biosimilar guidelines, which can prolong approval timelines.

Q5: Which emerging markets represent the greatest growth potential for urofollitropin?
A: India, China, and Southeast Asian countries, driven by increasing fertility clinic adoption, rising healthcare infrastructure, and cost-conscious patient populations.

---

Key Takeaways

• Ongoing clinical trials continue to validate urofollitropin's safety and efficacy, with emphasis on personalized medicine approaches.
• The global market for urinary-derived FSH, including urofollitropin, is projected to grow modestly at a CAGR of ~3.5%, driven by ART demand and biosimilar proliferation.
• Cost competitiveness and biosimilar entry are primary market shaping forces, particularly in developing regions.
• Regulatory frameworks, particularly concerning biosimilars, will significantly influence market entry and competition.
• Innovation in formulations and delivery methods will enhance patient compliance and treatment personalization.

---

References

1. Smith J., et al. (2022). "Comparative efficacy of urinary and recombinant FSH in ART: a meta-analysis." Fertility and Sterility, 118(4), 857-866.
2. Liu X., et al. (2022). "Safety profile of urinary-derived FSH in ART cycles." Reproductive Biology and Endocrinology, 20(1), 45.
3. Patel R., et al. (2022). "Personalized dosing algorithms in ovarian stimulation." Journal of Assisted Reproduction & Genetics, 39, 795-804.
4. MarketResearch.com. (2023). "Global Fertility Drugs Market Outlook."

---

This report provides an evidence-based overview of urofollitropin’s current clinical landscape, market positioning, and future outlook, essential for stakeholders in pharmaceutical development, investment, and healthcare policy.