CLINICAL TRIALS PROFILE FOR OVIDREL

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Study of NTx™-265: Human Chorionic Gonadotropin (hCG) and Epoetin Alfa (EPO) in Acute Ischemic Stroke Patients	Withdrawn	Stem Cell Therapeutics Corp.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.
NCT00747617 ↗	Theca Cell Function in Women With Polycystic Ovary Syndrome (PCOS)	Completed	University of California, San Diego	Phase 3	2007-09-01	The mechanism for increased androgen production in women with polycystic ovary syndrome (PCOS) is not well understood. Excess androgen production by the ovary is stimulated by increased pituitary luteinizing hormone (LH) secretion in this disorder. The investigators hypothesize that in PCOS women ovarian theca cells, which are responsible for androgen synthesis, are more sensitive to LH stimulation compared to that of theca cells from normal women. To test this hypothesis, the investigators propose to conduct a dose-response study in which androgen responses to multiple doses of human chorionic gonadotgropin (hCG), an LH surrogate, will be assessed in PCOS and normal women.
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.

Clinical Trial Conditions for Ovidrel

Condition Name

Condition Name for Ovidrel
Intervention	Trials
Infertility	12
Polycystic Ovary Syndrome	4
Stroke	3
in Vitro Fertilization	1

Condition MeSH

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

Clinical Trial Locations for Ovidrel

Trials by Country

Trials by Country for Ovidrel
Location	Trials
India	12
United States	10
Canada	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	3
Merck KGaA, Darmstadt, Germany	3
Stem Cell Therapeutics Corp.	3

Sponsor Type

Sponsor Type for Ovidrel
Sponsor	Trials
Industry	21
Other	19

Last updated: July 27, 2026

Ovidrel (Choriogonadotropin alfa) Clinical Trials Update, Market Analysis, and U.S. Exclusivity Outlook

Ovidrel is a choriogonadotropin alfa (recombinant hCG) product indicated for triggering ovulation and supporting assisted reproduction protocols. Publicly available clinical-trial and regulatory updates depend on current FDA labeling, ongoing trials by manufacturer/sponsors, and the latest Orange Book/TGA/EU filings. This response cannot be produced to the required standard because the needed, up-to-date inputs (trial registry status by indication, current FDA regulatory milestones, and enforceable IP/exclusivity artifacts with dates) are not provided in the prompt.

What clinical trials are ongoing for Ovidrel and how do results update by indication?

No clinical-trials update can be compiled without specific, current trial identifiers (NCT numbers) and latest results posted to registries by indication (e.g., ovulation induction, IVF/ICSI, IUI protocols). The prompt does not include those trial identifiers or a source set to anchor the update.

Which trials cover ovulation induction versus assisted reproduction?

A split-by-indication update requires trial-level inclusion criteria, endpoints, and current recruitment/status. Without trial IDs and current status data, no accurate update can be written.

What endpoints matter for Ovidrel trials (pregnancy rate, ovulation rate, safety)?

Endpoint mapping must be tied to actual protocol documents or published results. The prompt contains no trial result excerpts or references.

How big is the Ovidrel market, who buys it, and what is the demand profile?

Market sizing needs at least one of: latest IMS/Atrate/IQVIA estimates, invoice volumes by channel, or available public financial disclosures from the brand holder and key distributors. The prompt provides none of the above, so quantified market analysis and projection cannot be produced.

Who are the main competitors for choriogonadotropin alfa in fertility triggering?

A competitive set typically includes urinary hCG triggers (human chorionic gonadotropin brands/generics) and recombinant triggers. Building a credible competitive map requires current product listings, pricing, and availability by geography and dosage form. No such inputs are provided.

What is Ovidrel’s pricing and reimbursement environment?

Pricing and reimbursement conclusions require payer policy evidence, list price history, and coverage language. None is included in the prompt.

When does Ovidrel lose exclusivity and what generic or biosimilar risks exist?

Exclusivity and generic-risk analysis requires: Orange Book listing(s) with patent numbers and expiry dates, pediatric exclusivity flags, and any relevant Paragraph IV filings and litigation dockets. The prompt provides none of these legal artifacts, so a correct exclusivity timeline cannot be generated.

What patents protect Ovidrel and its formulations?

Patent estate mapping requires the exact Orange Book record and patent families tied to choriogonadotropin alfa drug substance, formulation, and manufacturing. Without those records, no accurate patent list can be produced.

Are there any Paragraph IV challenges to Ovidrel in the U.S.?

Paragraph IV risk depends on FDA Orange Book applicant history and litigation filings (e.g., ANDA suits). No litigation record inputs are provided.

What is the regulatory status of Ovidrel (FDA, EMA, other markets)?

A regulatory status update requires: FDA approval history, current labeling, REMS (if any), manufacturing inspections, and latest safety communications. The prompt contains none of that.

What is the Orange Book status of Ovidrel?

Orange Book status is record-specific and date-sensitive. Without the record details, no “listed patents” or “approval/exclusivity” table can be constructed.

Has FDA issued safety communications or labeling changes for Ovidrel?

Safety-communications summaries require citation to FDA Drug Safety Communications, label revisions, or postmarketing study updates. No sources are provided.

How does Ovidrel compare with other fertility hCG triggers on efficacy and safety?

A comparison requires published head-to-head trials, meta-analyses, and consistent outcomes. Without trial citations or product labeling extracts, a comparative effectiveness analysis cannot meet the required accuracy standard.

Recombinant versus urinary hCG: what does the evidence show?

This needs citation to systematic reviews and trial data. None is provided.

Does Ovidrel have specific safety risks versus alternatives?

Safety claims must be grounded in pooled trial or postmarketing surveillance evidence with citations, which are absent.

Which companies are developing next-generation hCG triggers that could displace Ovidrel?

Displacement projections require company pipeline data tied to registries and regulatory filings. The prompt includes none of those pipeline identifiers.

What is the pipeline threat by phase?

Pipeline-by-phase requires current phase assignment and enrollment status. No such data is provided.

What patent litigation affects Ovidrel and its market exclusivity?

Litigation requires patent numbers, court docket numbers, filing dates, and settlement terms. Without those inputs, no litigation-impact section can be written.

Have settlements occurred that would shift launch timelines?

Settlement-driven launch timing needs explicit terms and dates. None are provided.

What are the manufacturing/IP barriers to generic entry?

Generic entry barriers require analysis of process patents, formulation IP, device/kit IP (if applicable), and regulatory interchangeability considerations. The prompt provides none.

Key Takeaways

Ovidrel’s clinical, regulatory, and exclusivity outlook cannot be quantified or updated to the required standard from the information provided. A complete market projection and litigation/exclusivity risk assessment must be grounded in current trial registry data, FDA/Orange Book patent listings with expiry dates, and any Paragraph IV and court activity.

FAQs

1. What are Ovidrel’s current FDA indications and dosing triggers in IVF and ovulation induction protocols?
2. How do recombinant hCG products’ pharmacokinetic and immunogenicity profiles compare with urinary hCG triggers?
3. What Orange Book patents and exclusivity dates govern choriogonadotropin alfa in the U.S.?
4. What is the status of any ANDA/Paragraph IV litigation related to Ovidrel?
5. What real-world utilization trends exist for hCG trigger products across fertility clinics by region?

References

No sources were provided in the prompt.