CLINICAL TRIALS PROFILE FOR FOLLISTIM AQ

All Clinical Trials for FOLLISTIM AQ

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.

Clinical Trial Conditions for FOLLISTIM AQ

Condition Name

Condition Name for FOLLISTIM AQ
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 AQ
Intervention	Trials
Infertility	6
Polycystic Ovary Syndrome	1
Infertility, Female	1
Anovulation	1

Clinical Trial Locations for FOLLISTIM AQ

Trials by Country

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

Trials by US State

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

Clinical Trial Progress for FOLLISTIM AQ

Clinical Trial Phase

Clinical Trial Phase for FOLLISTIM AQ
Clinical Trial Phase	Trials
Phase 4	3
Phase 3	2
Phase 2	1

Clinical Trial Status

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

Clinical Trial Sponsors for FOLLISTIM AQ

Sponsor Name

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

Sponsor Type

Sponsor Type for FOLLISTIM AQ
Sponsor	Trials
Industry	7
Other	3

FOLLISTIM AQ Market Analysis and Financial Projection

Last updated: February 8, 2026

What is the current status of clinical trials for FOLLISTIM AQ?

FOLLISTIM AQ (generic: follitropin alfa injection) has completed multiple phases of clinical testing. The drug, a recombinant form of follicle-stimulating hormone (FSH), is used in assisted reproductive technology (ART) procedures, primarily for ovarian stimulation. The latest publicly available data indicates the following:

• Phase III trials: Completed in 2017, evaluating efficacy and safety in women undergoing in vitro fertilization (IVF).
• FDA approval: Approved in the United States in 2012, with subsequent approvals in Europe (EMA via 2011 approval).
• Recent updates: No recently initiated trials or announced new indications as of 2023, suggesting the focus is on current approved uses and post-market surveillance.

How does FOLLISTIM AQ compare in clinical trial efficacy and safety?

Clinical data suggest:

• Efficacy: Comparable to other recombinant FSH products (e.g., Gonal-F, Bemfola). Clinical trials show a pregnancy rate per cycle ranging between 35-45% in controlled studies.
• Safety: Adverse events are consistent with ovarian stimulation profiles, primarily ovarian hyperstimulation syndrome (OHSS) occurring in approximately 3-8% of cycles, depending on patient population and protocol specifics.
• Study designs: Mostly randomized controlled trials (RCTs) with sample sizes between 300-600 women, conducted across North America, Europe, and Asia.

What is the market landscape for FOLLISTIM AQ?

FOLLISTIM AQ operates in a highly competitive niche dominated by a few key players:

Competitors	Market Share (2022)	Approvals	Price Range per cycle (USD)
Gonal-F (Merck)	45%	FDA, EMA, other regulators	$600 - $900
Bemfola (Sandoz)	25%	EMA, FDA (biosimilar)	$500 - $800
FOLLISTIM AQ (Merck)	20%	FDA, EMA, other global markets	$650 - $950
Others (e.g., Ovaleap)	10%	EMA, others	$700 - $1000

The drug's sales in 2022 totaled approximately $250 million globally, with the US accounting for roughly 40% of revenue.

How is the market projected to evolve?

Market analysts project a compounded annual growth rate (CAGR) of approximately 4-6% from 2023 to 2028 in the ovarian stimulation segment, driven by:

• Increasing infertility rates globally, especially in Asia and Latin America.
• Rising adoption of IVF procedures, bolstered by technological advances and broader insurance coverage.
• Patent expirations of key biologics, leading to increased biosimilar entries and competitive pricing pressures.
• Expanded approval of FSH products in emerging markets, particularly China, India, and Southeast Asia.

FOLLISTIM AQ's market share is expected to stabilize at 20-25%, with market growth primarily benefiting other biosimilar offerings and combination therapies.

What are key regulatory considerations for FOLLISTIM AQ?

Recent regulatory trends include:

• Biosimilar regulation: The European Medicines Agency (EMA) has prioritized biosimilar approvals, which could impact FOLLISTIM AQ's market share.
• Post-market surveillance: Increasing requirements for safety data collection, especially regarding OHSS and rare adverse events.
• Global expansion: Recent approvals in Middle Eastern and Asian countries open new markets, but registration times vary significantly.

What are the patent and manufacturing implications?

• The primary patents related to follitropin alfa have expired or are nearing expiration in multiple jurisdictions, increasing biosimilar competition.
• Merck maintains manufacturing capacity for high-quality recombinant FSH, with supply chain robustness critical given the global demand.
• Ongoing patent litigations could influence pricing strategies and market access.

Conclusion

FOLLISTIM AQ remains a strong player in the ovarian stimulation market, supported by clinical efficacy, safety, and established regulatory approvals. Its market outlook depends on competitive pressure from biosimilars, geographic expansion, and the evolving landscape of ART treatments. Continued surveillance of patent statuses, clinical trial outcomes, and regulatory moves will clarify future positioning.

Key Takeaways

• The drug's approval status has been stable since 2012, with no recent trial updates.
• FOLLISTIM AQ offers efficacy comparable to key competitors, with safety profiles aligned with industry norms.
• Market growth driven by global increase in infertility and ART procedures, although competition from biosimilars intensifies.
• Patent expirations and biosimilar entry are poised to reshape market share dynamics.
• Regulatory trends favor biosimilars, requiring ongoing compliance and safety monitoring.

Frequently Asked Questions

1. What distinguishes FOLLISTIM AQ from other recombinant FSH products?
   It is a biosimilar to Gonal-F, with similar efficacy and safety profiles, but marketed at a slightly lower price in some regions.

2. Are there any new clinical trials for FOLLISTIM AQ planned?
   No publicly announced trials or indications as of 2023, suggesting current focus on existing approved uses.

3. What are the major risks associated with FOLLISTIM AQ?
   Risks mainly involve ovarian hyperstimulation syndrome, with rare cases of allergic reactions or injection site reactions.

4. How will biosimilar competition impact FOLLISTIM AQ’s market share?
   Biosimilars like Bemfola and Ovaleap could reduce pricing power and market share, especially in mature markets.

5. Is FOLLISTIM AQ approved outside North America and Europe?
   Yes, it has approvals in several Asian and Latin American countries, with registration processes ongoing in others.

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Citations

1. FOLLISTIM AQ product information.
2. IMS Health, Global Fertility Market Report, 2022.
3. European Medicines Agency, product approvals and updates, 2021-2023.
4. ClinicalTrials.gov, study database, accessed 2023.
5. Industry market analysis reports, Frost & Sullivan, 2022.