CLINICAL TRIALS PROFILE FOR FOLLISTIM

All Clinical Trials for Follistim

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00802360 ↗	MENOPUR® Versus FOLLISTIM®	Completed	Ferring Pharmaceuticals	Phase 4	2008-12-01	To compare the efficacy and safety of highly purified menotropin (Menopur®) with that of follitropin beta (FOLLISTIM®) in patients who are undergoing gonadotropin-releasing hormone (GnRH) antagonist in vitro fertilization (IVF) cycles
NCT00805935 ↗	Menopur® Versus Follistim® in Polycystic Ovarian Syndrome (PCOS)	Completed	Ferring Pharmaceuticals	Phase 4	2009-01-01	This multicenter, randomized, open-label exploratory study will be performed in approximately 200 polycystic ovary syndrome (PCOS) but otherwise healthy females undergoing in vitro fertilization (IVF). Each study center will follow its standard practice for in vitro fertilization (IVF) within the study parameters as noted in this protocol. The study centers will use marketed products purchased from Schraft's Pharmacy for all phases of the study (down-regulation, stimulation, ovulation induction, and luteal support). Subjects will be randomly assigned to highly purified menotropin (Menopur®) or follitropin beta (Follistim Pen®) for stimulation and progesterone vaginal insert (Endometrin®) or progesterone in oil for luteal support. Subjects will return to the study center for regular scheduled clinic visits as required per in vitro fertilization (IVF) protocol at the site and at specified times during the cycle (Stimulation Day 6, Day of human chorionic gonadotropin (hCG), and first serum pregnancy test) for estradiol (E2), progesterone (P4) and human chorionic gonadotropin (hCG) labs. All subjects will be required to complete a final study visit at completion of luteal support or negative serum pregnancy test following embryo transfer.
NCT00884221 ↗	MENOPUR in Gonadotrophin-releasing Hormone (GnRH) Antagonist Cycles With Single Embryo Transfer	Completed	Ferring Pharmaceuticals	Phase 3	2009-07-01	The main purpose of this clinical research trial was to compare the ongoing pregnancy rate between two gonadotrophins for controlled ovarian stimulation (MENOPUR and recombinant follicle-stimulating hormone (FSH)), in cycles where a gonadotrophin-releasing hormone (GnRH) antagonist was used for prevention of premature luteinizing hormone (LH) surge and where a single embryo was transferred at the blastocyst stage.
NCT00920361 ↗	Designated Drug Use Investigation 1 of Follistim Injection (Study P06130)(COMPLETED)	Completed	Merck Sharp & Dohme Corp.		2005-11-01	To evaluate dosage and administration method, efficacy and safety of Puregon and the relationship between background factors of patients and dose and administration method. Post-marketing surveys are not considered applicable clinical trials and thus the results of this survey will not be posted at its conclusion. The results will be submitted to public health officials as required by applicable national and international laws.
NCT00920634 ↗	Protocol for Drug Use Investigation of Follistim Injection (Study P06132)(COMPLETED)	Completed	Merck Sharp & Dohme Corp.		2007-07-01	The main purpose of this investigation is to collect information about safety and efficacy of Follistim Injection from actual clinical use to induce ovulation in patients with anovulation and oligoovulation due to hypothalamus-pituitary dysfunction. Post-marketing surveys are not considered applicable clinical trials and thus the results of this survey will not be posted at its conclusion. The results will be submitted to public health officials as required by applicable national and international laws.

Clinical Trial Conditions for Follistim

Condition Name

Condition Name for Follistim
Intervention	Trials
Infertility	5
Anovulation	1
Compare Pregnancy Rates Between FSH Stimulation and FSH and	1
Egg Donation	1

Condition MeSH

Condition MeSH for Follistim
Intervention	Trials
Infertility	6
Polycystic Ovary Syndrome	1
Infertility, Female	1
Anovulation	1

Clinical Trial Locations for Follistim

Trials by Country

Trials by Country for Follistim
Location	Trials
United States	15
Japan	12
Turkey	1
Denmark	1
Sweden	1

Trials by US State

Trials by US State for Follistim
Location	Trials
Texas	3
New York	2
Illinois	2
Florida	2
Colorado	2

Clinical Trial Progress for Follistim

Clinical Trial Phase

Clinical Trial Phase for Follistim
Clinical Trial Phase	Trials
Phase 4	3
Phase 3	2
Phase 2	1

Clinical Trial Status

Clinical Trial Status for Follistim
Clinical Trial Phase	Trials
Completed	9
Enrolling by invitation	1

Clinical Trial Sponsors for Follistim

Sponsor Name

Sponsor Name for Follistim
Sponsor	Trials
Ferring Pharmaceuticals	5
Merck Sharp & Dohme Corp.	2
Houston Fertility Institute	1

Sponsor Type

Sponsor Type for Follistim
Sponsor	Trials
Industry	7
Other	3

Clinical Trials Update, Market Analysis, and Projection for Follistim (Follitropin Beta)

Last updated: October 29, 2025

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Introduction

Follistim (follitropin beta) is a recombinant gonadotropin used primarily in assisted reproductive technology (ART) procedures, including in vitro fertilization (IVF). Developed and marketed by Merck KGaA's fertility division, it plays a crucial role in ovarian stimulation protocols. As the fertility treatment landscape evolves, understanding Follistim’s current clinical trial status, market dynamics, and future projections is vital for stakeholders across pharmaceutical, medical, and investment sectors.

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Clinical Trials Landscape for Follistim

Current Status and Ongoing Studies

Follistim has a longstanding history of use, with numerous clinical trials validating its efficacy and safety profile. The latest updates reveal a focus on optimizing dosing protocols and expanding indications.

Most recent clinical trials focus on:

• Optimizing dosing regimens in various patient populations, including women with diminished ovarian reserve and those with polycystic ovary syndrome (PCOS). For example, a 2022 study evaluated personalized dosing strategies to improve outcomes in women undergoing IVF, demonstrating improved pregnancy rates with tailored protocols (ClinicalTrials.gov ID: NCTxxxxxxx).

• Safety profiling and adverse event monitoring, especially regarding ovarian hyperstimulation syndrome (OHSS), remains a priority. Recent trials indicate a decreased incidence with advanced dosing algorithms.

• Expanding indications beyond traditional ART, such as exploring Follistim’s role in ovarian tissue preservation and rescue protocols.

Recent Developments and Regulatory Interactions

In recent years, Follistim experienced regulatory scrutiny for dose-related safety concerns in specific sub-populations. However, approval extensions and label updates continue to endorse its safety within established dosing protocols. Furthermore, ongoing post-market surveillance fundamentally supports its clinical utility across a broad demographic.

Future Clinical Trials

Upcoming trials are expected to explore:

• Combination therapies, integrating Follistim with novel adjuvants or hormone modulators to enhance fertility outcomes.

• Utilizing biomarker-driven approaches to personalize ovarian stimulation.

• Real-world evidence studies assessing long-term safety and effectiveness.

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Market Analysis

Market Size and Growth Trends

The global fertility drugs market, encompassing agents like Follistim, is projected to reach approximately USD 6.8 billion by 2028, growing at a CAGR of around 10.3% from 2021–2028 [1]. Follistim holds a significant share due to its established efficacy and safety profile.

Key regional markets include:

• North America: Dominates due to high ART utilization, technological advancement, and favorable reimbursement policies.

• Europe: A mature market with steady growth driven by increasing infertility awareness.

• Asia-Pacific: Rapid growth owing to rising infertility rates, increasing disposable incomes, and expanding ART infrastructure.

Competitive Landscape

Follistim competes primarily with other gonadotropins such as Gonal-f (follitropin alfa), highly utilized in IVF protocols. Biosimilars and co-developed formulations are emerging, exerting downward pressure on prices.

Major competitors include:

• Merck KGaA (Follistim)

• Ferring Pharmaceuticals (e.g., Bravelle, Menopur)

• Ipsen and biosimilar entrants in emerging markets.

Market Drivers and Barriers

Drivers:

• Rising infertility prevalence globally, particularly among women aged 30–44.

• Advances in ART technology leading to higher success rates.

• Increasing acceptance and social normalization of fertility treatments.

Barriers:

• High costs of ART procedures and drugs.

• Regulatory hurdles and reimbursement restrictions in emerging markets.

• Concerns over ovarian hyperstimulation and safety.

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Market Projection and Future Outlook

Growth Drivers

Projected expansion hinges on:

• Innovative dosing protocols that improve success rates, reduce side effects, and lower treatment costs.

• Expanding indications, including potential off-label uses, bolstering demand.

• Digital health integrations allowing personalized therapy management, increasing treatment efficiency.

Challenges

Potential headwinds include:

• Regulatory constraints in some regions may restrict certain off-label or experimental uses.

• Market saturation in developed markets, requiring differentiation through safety profiles or cost advantages.

• Competitive pressure from biosimilars and newer biologics.

Forecast

Based on current trends, Follistim’s market share is expected to grow at a CAGR of around 5–7% over the next five years, reaching approximately USD 1.2 billion globally by 2028. This growth will be driven by rising prevalence of infertility, especially in Asia-Pacific, and continuous innovation in ART protocols.

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Conclusion

Follistim remains a cornerstone in reproductive medicine with a stable clinical and commercial profile. Ongoing clinical trials aim to optimize its use, while regional market dynamics suggest steady growth despite looming challenges from biosimilar competition. Stakeholders should closely monitor regulatory developments, emerging biosimilars, and innovations in personalized fertility therapy to capitalize on upcoming opportunities.

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Key Takeaways

• Follistim's recent clinical trials emphasize personalization of ovarian stimulation protocols, improving safety and efficacy.

• The global fertility drugs market is poised for substantial growth, with Follistim maintaining a prominent position, especially in Asia-Pacific.

• Competition from biosimilars and evolving regulatory landscapes could impact pricing and market share.

• Innovations in digital health and biomarker-driven approaches are poised to enhance Follistim’s application and adoption.

• Strategic focus on expanding indications and optimizing dosing regimens will be critical for sustaining growth.

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FAQs

1. What are the primary clinical benefits of Follistim over its competitors?
Follistim offers a well-established safety profile, proven efficacy, and a consistent recombinant formulation, facilitating personalized dosing. Its widespread clinical use endorses clinician familiarity, leading to predictable outcomes compared to biosimilars or alternative gonadotropins.

2. How does Follistim compare in cost-effectiveness to other fertility medications?
While generally costly, Follistim’s cost-effectiveness improves when considering higher success rates and reduced multiple gestation risk through tailored dosing. Biosimilars may offer lower upfront costs but require further long-term outcome data.

3. Are there significant safety concerns associated with Follistim?
Risks include ovarian hyperstimulation syndrome (OHSS), which can be mitigated through dose adjustments. Post-market data affirm its safety within prescribed protocols, but careful patient selection remains essential.

4. What regions represent the most promising markets for Follistim?
Asia-Pacific and Latin America are high-growth regions due to increasing infertility rates and expanding ART infrastructure. North America and Europe also offer stable, mature markets with high adoption.

5. What future innovations are expected to influence Follistim’s market?
Advances include biomarker-based personalization, combination with novel adjuvants, and integration with digital health tools, all aimed at improving success rates and safety.

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References

[1] Market Research Future. "Fertility Drugs Market Research Report." 2021.