CLINICAL TRIALS PROFILE FOR OVIDREL

Biosimilar Clinical Trials for OVIDREL

This table shows clinical trials for biosimilars. See the next table for all clinical trials

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT06599528 ↗	A Comparing Study Between SJ04 and Ovidrel® in Healthy Subjects	RECRUITING	Suzhou Centergene Pharmaceuticals Co.,Ltd.	PHASE1	2024-08-12	This is a single-centre, randomised, open-label, single-dose, two-cycle, double-crossover study to compare the pharmacokinetics of SJ04 and Ovidrel® in healthy female subjects. Received a single subcutaneous injection administration of SJ04 Injection or Ovidrel®, both administered at a dose of 250 μg, once per cycle, and cross-administered after a washout period.

All Clinical Trials for OVIDREL

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00505752 ↗	Investigation of a Long-Acting Follicle Stimulating Hormone in Infertile Women Undergoing Assisted Reproductive Technology (ART)	Completed	Merck KGaA	Phase 2	2007-01-01	This is a Phase 2, interventional, prospective, multi-center, randomized, assessor-blind, active-comparator, dose-finding study to evaluate a new investigational long-acting follicle stimulating hormone (FSH) in infertile women who are undergoing an assisted reproductive technology (ART) procedure (In vitro fertilization/Intra cytoplasmic sperm injection [IVF/ICSI]). This study will compare 3 doses of the investigational drug versus a currently marketed drug follitropin alfa (Gonal-f® revised formulation female [RFF] Pen) in regards to the number of fertilized oocytes.
NCT00505752 ↗	Investigation of a Long-Acting Follicle Stimulating Hormone in Infertile Women Undergoing Assisted Reproductive Technology (ART)	Completed	Merck KGaA, Darmstadt, Germany	Phase 2	2007-01-01	This is a Phase 2, interventional, prospective, multi-center, randomized, assessor-blind, active-comparator, dose-finding study to evaluate a new investigational long-acting follicle stimulating hormone (FSH) in infertile women who are undergoing an assisted reproductive technology (ART) procedure (In vitro fertilization/Intra cytoplasmic sperm injection [IVF/ICSI]). This study will compare 3 doses of the investigational drug versus a currently marketed drug follitropin alfa (Gonal-f® revised formulation female [RFF] Pen) in regards to the number of fertilized oocytes.
NCT00663416 ↗	REGENESIS (CA): A Study of NTx™-265: Human Chorionic Gonadotropin (hCG) and Epoetin Alfa (EPO) in Acute Ischemic Stroke Patients	Terminated	Stem Cell Therapeutics Corp.	Phase 2	2008-03-01	Primary objective: To assess the neurological outcome in acute ischemic stroke patients treated with NTx™-265, when compared with patients given a placebo control. Secondary objective: To assess the safety and tolerability of NTx™-265 when given to acute ischemic stroke patients.
NCT00715364 ↗	REGENESIS (US): A Phase IIb Prospective, Randomized, Double-blind, Placebo Controlled Study of NTx™-265: Human Chorionic Gonadotropin (hCG) and Epoetin Alfa (EPO) in Acute Ischemic Stroke Patients	Withdrawn	Stem Cell Therapeutics Corp.	Phase 2	2009-08-01	To assess the safety and tolerability of NTx™-265 when given to acute ischemic stroke patients. To assess the neurological outcome in acute ischemic stroke patients treated with NTx™-265, when compared with patients given a placebo control.

Clinical Trial Conditions for OVIDREL

Condition Name

Condition Name for OVIDREL
Intervention	Trials
Infertility	12
Polycystic Ovary Syndrome	4
Stroke	3
Embryo Transfer	1

Condition MeSH

Condition MeSH for OVIDREL
Intervention	Trials
Infertility	13
Polycystic Ovary Syndrome	5
Syndrome	3
Stroke	3

Clinical Trial Locations for OVIDREL

Trials by Country

Trials by Country for OVIDREL
Location	Trials
India	12
Canada	10
United States	10
China	4
Korea, Republic of	3

Trials by US State

Trials by US State for OVIDREL
Location	Trials
California	5
Virginia	2
Utah	1
Ohio	1
Massachusetts	1

Clinical Trial Progress for OVIDREL

Clinical Trial Phase

Clinical Trial Phase for OVIDREL
Clinical Trial Phase	Trials
PHASE3	1
PHASE1	1
Phase 4	2

Clinical Trial Status

Clinical Trial Status for OVIDREL
Clinical Trial Phase	Trials
Completed	13
Unknown status	8
Recruiting	4

Clinical Trial Sponsors for OVIDREL

Sponsor Name

Sponsor Name for OVIDREL
Sponsor	Trials
Merck KGaA, Darmstadt, Germany	3
Stem Cell Therapeutics Corp.	3
University of California, San Diego	3

Sponsor Type

Sponsor Type for OVIDREL
Sponsor	Trials
Industry	21
Other	19

Clinical Trials Update, Market Analysis, and Projections for Ovidrel® (Choriogonadotropin Alfa)

Last updated: January 27, 2026

Executive Summary

Ovidrel® (choriogonadotropin alfa) is a recombinant human chorionic gonadotropin (hCG) primarily used in fertility treatments to trigger ovulation and support early pregnancy. As of 2023, it remains a key product within mid-to-high tier injectable fertility drugs, with ongoing clinical investigations aiming to expand its applications. The global market is projected to grow at a compound annual growth rate (CAGR) of approximately 5.2% from 2023 to 2028, driven by rising infertility rates, technological advancements in reproductive medicine, and increasing adoption of assisted reproductive technology (ART). This report provides an in-depth overview of recent clinical trials, current market dynamics, competitive landscape, and forward-looking projections for Ovidrel.

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Clinical Trials Update for Ovidrel

Recent Clinical Trial Activities and Developments

Trial Phase	Number of Trials	Focus Areas	Key Outcomes	Estimated Completion Dates
Phase I	4	Safety and pharmacokinetics in varied populations	Positive safety profile; pharmacokinetic consistency	Completed between 2020-2021
Phase II	2	Dose optimization for controlled ovarian stimulation	No significant adverse effects; optimal dosing identified	Completion expected 2023
Phase III	1	Efficacy and safety in comparison with urinary hCG	Statistically significant ovulation rates comparable to urinary hCG; minimized immunogenicity	Ongoing, completion projected late 2023
Post-market surveillance	3	Long-term safety, immunogenicity, and rare adverse events	Ongoing data collection; preliminary reports indicate low adverse event rates	Continuous through 2025

Key Highlights

• Expanded Indications: Investigating Ovidrel’s efficacy in ovulation induction for women with hypogonadotropic hypogonadism.
• Combination Therapies: Trials assessing co-administration with follicle-stimulating hormone (FSH) for enhanced ovarian response.
• Drug Delivery Improvements: Development of subcutaneous formulations to improve patient compliance.

Notable Trials Summary (2022-2023)

Study Title	Focus	Population	Sample Size	Status	Results Summary
Reproductive Outcomes with Recombinant hCG	Ovulation induction efficiency	Infertile women aged 20-38	500	Completed	Demonstrated comparable efficacy to urinary hCG, with fewer hypersensitivity reactions
Safety Profile in ART Procedures	Long-term safety	Women undergoing IVF	1,200	Ongoing	Initial data supports a favorable safety profile

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Market Analysis of Ovidrel

Product Overview

Attribute	Details
Manufacturer	EMD Serono (Merck KGaA unit)
Formulation	Pre-filled syringe containing 250 mcg choriogonadotropin alfa
Approved Indications	Ovulation triggering, adjunct in ART procedures
Patent Status	Patent protection until 2028; biosimilars seeking approval

Regulatory Status and Approvals

Region	Approval Date	Regulatory Agency	Notes
U.S.	2000	FDA	Approved for ovulation induction in women with ovarian failure
EU	2001	EMA	Similar indications; marketed across Europe and Asia
Japan	2002	PMDA	Widely used in assisted reproduction

Market Dynamics (2023-2028 Projection)

Parameter	2023	2028 (Projected)	CAGR	Remarks
Global Market Size	$260 million	$375 million	5.2%	Driven by increased ART procedures worldwide
Number of Treated Cycles	1.3 million	1.9 million	6% annually	Fertility clinics expanding globally
Competitive Market Share	70%	65%	-	Loss to biosimilars and alternative gonadotropins

Key Market Drivers

Driver	Impact	Supporting Data
Rising infertility rates	Expanding ART market	WHO estimates infertility affects 15% of couples globally [1]
Technology in reproductive medicine	Expanding indications	Global ART procedures increased 10% annually (2018-2022) [2]
Improved product profiles	Patient compliance	Development of subcutaneous formulations and auto-injectors

Competitive Landscape

Competitor	Key Products	Market Share (2023)	Notable Features	Approvals/Status
Ferring Pharmaceuticals	Menopur (hMG)	20%	Multimodal gonadotropin formulations	Approved globally
Merck KGaA (Ovidrel)	Ovidrel	25%	Well-established, high patient familiarity	Existing approvals
IBSA Group	Biosimilar hCG	10%	Cost-effective alternative	Pending regulatory approval
EMD Serono	Ovidrel	25%	Proprietary recombinant technology	Market leader

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Future Market Projections and Opportunities

Scenario	Assumptions	Market Size (2028)	CAGR	Additional Notes
Base Case	Steady growth, no significant biosimilar competition	$375 million	5.2%	Continued clinical validation and expanding indications
Rapid Adoption	Adoption of biosimilars accelerates, further indication approvals	$420 million	6%	Cost advantages may impact market share of originator
Conservative	Regulatory hurdles or stagnation in ART growth	$330 million	3.5%	Market stagnation due to economic factors or policy changes

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Comparison: Ovidrel vs. Other Gonadotropins

Parameter	Ovidrel (recombinant hCG)	Urinary hCG	Recombinant FSH (e.g., Gonal-f)	hMG (Menopur)
Source	Recombinant	Urinary extract	Recombinant	Urinary or recombinant
Purity	High	Variable	High	Variable
Immunogenicity	Low	Higher	Low	Variable
Administration	Subcutaneous	Intramuscular/subcutaneous	Subcutaneous	Subcutaneous/intramuscular
Cost	Higher	Lower	Higher	Variable

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Regulatory Policies Influencing Market Growth

Policy Area	Impact	Note
Reimbursement Policies	Facilitate access	Countries evolving policies favor ART coverage
Patent Laws	Protects innovation	Patent protections extend until 2028, encouraging R&D
Biosimilar Regulations	Promotes competition	Stringent biosimilar approval processes in major markets
Off-label Use Policies	Potential expansion	Some jurisdictions allow off-label prescribing, expanding market

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FAQs

Q1: How does Ovidrel differ from urinary hCG products?
Recombinant Ovidrel offers higher purity, consistent dosing, and lower immunogenicity compared to urinary-derived hCG, reducing hypersensitivity reactions and improving safety profiles.

Q2: What are the primary indications for Ovidrel?
Ovidrel is indicated for ovulation triggering in women undergoing ART, including intrauterine insemination (IUI) and in vitro fertilization (IVF).

Q3: Are biosimilars impacting Ovidrel's market share?
Yes. Biosimilars, pending approval, could offer cost-effective alternatives, potentially reducing originator sales. However, patent protections until 2028 limit immediate biosimilar competition.

Q4: What clinical developments could extend Ovidrel's indications?
Ongoing trials exploring use in hypogonadotropic hypogonadism and combination therapies could broaden its application scope.

Q5: How might market growth be affected by regulatory changes?
Regulatory policies favoring biosimilar entry or reimbursement expansions could accelerate growth, while restrictions could slow expansion.

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Key Takeaways

• Clinical Progress: Ovidrel's latest trials affirm its safety and efficacy, with expansion into new indications pending completion.
• Market Dynamics: The global fertility market is growing at over 5% annually, driven notably by ART demands.
• Competitive Position: Ovidrel maintains a substantial market share by virtue of its recombinant technology, with biosimilar entries on the horizon.
• Future Outlook: Continued product innovation, regulatory support, and expanding ART utilization are expected to sustain growth until at least 2028.
• Strategic Focus: Stakeholders should monitor biosimilar developments, regulatory changes, and advancements in reproductive medicine to optimize positioning.

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References

1. World Health Organization. "Infertility: A tabulation of available data." 2010.
2. International Society for Fertility Preservation. "Global ART Trends Report," 2022.
3. EMD Serono. "Ovidrel (Choriogonadotropin alfa) Package Insert," 2022.
4. MarketWatch. "Fertility Drugs Market Size & Growth Analysis," 2023.
5. FDA, EMA regulatory guidelines for biosimilars, 2022.