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Drug

Corifollitropin alfa

Approved · EMA
Late-stage development

Also known as Corifolitropina alfa.

RxNorm874192UNIIT7K20Y2GWY
1
Regulatory events
Latest activity
beta

Recent clinical, regulatory, research and industry developments relating to this drug.

Continuous Ovarian Stimulation in DUOSTIM Cycles.

Clinical trial2025-05-18Results posted · ClinicalTrials.gov

A Phase III, Randomized, Double-Blind, Active-Controlled, Non-Inferiority Clinical Trial to Investigate the Efficacy and Safety of a Single Injection of Org 36286 (Corifollitropin Alfa) to Induce Multifollicular Development for Controlled Ovarian Stimulation Using Daily Recombinant FSH as Reference

Clinical trial2024-06-20Results posted · ClinicalTrials.gov

Follow-up Protocol to Collect the Outcome and Safety of Frozen-thawed Embryo Transfer (FTET) Cycles After Cryopreservation of Embryos in Clinical Study P06029 (Phase 3; Protocol No. P06031)

Clinical trial2024-06-20Results posted · ClinicalTrials.gov

A Phase III, Randomized, Double-blind, Active-controlled, Equivalence Clinical Trial to Investigate the Efficacy and Safety of a Single Injection of 100 µg Org 36286 (Corifollitropin Alfa) to Induce Multifollicular Development for Controlled Ovarian Stimulation (COS) Using Daily Recombinant FSH (recFSH) as a Reference

Clinical trial2024-06-18Results posted · ClinicalTrials.gov

A Phase III, Uncontrolled Trial to Assess the Non-immunogenicity and Safety of Org 36286 in Patients Undergoing Repeated Controlled Ovarian Stimulation Cycles Using a Multiple Dose GnRH Antagonist Protocol

Clinical trial2024-06-18Results posted · ClinicalTrials.gov

A Phase III, Multi-center, Open Label, Uncontrolled Trial to Investigate the Efficacy and Safety of MK-8962 (Corifollitropin Alfa) in Combination With Human Chorionic Gonadotropin (hCG) in Inducing Increased Testicular Volume and Spermatogenesis in Adult Men With Hypogonadotropic Hypogonadism Who Remain Azoospermic When Treated With hCG Alone (Phase III; Protocol No. MK-8962-031-00 [Also Known as SCH 900962, P07937])

Clinical trial2024-05-24Results posted · ClinicalTrials.gov

A Phase III, Multi-Center, Open Label, Single-Group Trial to Investigate the Efficacy and Safety of MK-8962 (Corifollitropin Alfa) in Combination With Human Chorionic Gonadotropin (hCG) for Initiation or Restoration of Puberty as Assessed by Increased Testicular Volume in Adolescent Males 14 to <18 Years Old With Hypogonadotropic Hypogonadism (MK-8962-043)

Clinical trial2024-05-23Results posted · ClinicalTrials.gov

Reduction of Progesterone Elevation at Trigger in Poor Responder Bologna' Criteria Patients After Controlled Ovarian Stimulation With Long Acting Standard Stimulation Protocol Compared With Conventional Daily Protocol: a Single Center Prospective Randomized Fase IV Trial

Clinical trial2024-05-06Completed · ClinicalTrials.gov

A Comparison Between Corifollitropin Alfa and Recombinant FSH for Follicular Recruitment in Women With Polycystic Ovaries Who Undergo IVM Treatment

Clinical trial2022-12-31Completed · ClinicalTrials.gov

Ovarian Response to Controlled Ovarian Stimulation Measured Through the Follicular Output Rate (FORT)

Clinical trial2019-01-31Completed · ClinicalTrials.gov

Prospective Randomized Trial Comparing Corifollitropin-alfa Late Start (Day 4) vs. Corifollitropin-alfa Standard Start (Day 2) in Expected Poor, Normal and High-responders Undergoing IVF/ICSI

Clinical trial2018-12-31Completed · ClinicalTrials.gov

Approval: Elonva (EMA)

Regulatory2010-01-25EMA

Profile

Identifiers & mechanism

Canonical identifiers, marketed brand names and mechanism, resolved across RxNorm, ChEMBL and ATC.

Canonical name
Corifollitropin alfa
Aliases & brands
Corifolitropina alfa
RxNorm CUI
874192
UNII
T7K20Y2GWY
Regulatory jurisdictions
ema

Regulatory timeline

1 event

The complete regulatory record, grouped by authority — approvals, safety advisories and label changes. Each authority shows its most recent events; expand one to read its full history.

Earliest approval
2010-01-25
Latest approval
2010-01-25
Authorities
EMA
Total events
1
emaEuropean Medicines Agency· 1 event
2010-01-25Approval
Approval: Elonva (EMA)
Indication: Controlled Ovarian Stimulation (COS) in combination with a GnRH antagonist for the development of multiple follicles in women participating in an Assisted Reproductive Technology… Show full indication

Controlled Ovarian Stimulation (COS) in combination with a GnRH antagonist for the development of multiple follicles in women participating in an Assisted Reproductive Technology (ART) program. Elonva is indicated for the treatment of adolescent males (14 to less than 18 years and older) with hypogonadotropic hypogonadism, in combination with human Chorionic Gonadotropin (hCG).

Evidence ↗

Contains information from the European Medicines Agency (European Medicines Agency), © EMA, reused under CC BY 4.0.

Clinical trials

26 trials

The current development programme across all trial phases — status mix, phase distribution and the late-stage studies shaping the evidence base.

Development programme
CLINICALTRIALS.GOV · LIVE REGISTRY
26
registered trials across all phases
LATEST COMPLETION 2024
21
Late-stage (III+)
21
Completed
5
Discontinued
PHASE DISTRIBUTIONn = 26
Phase 1 / 21Phase 24Phase 38Phase 411Phase N / A2

Late-stage studies

Phase III+ trials still open or recently active — where late-stage evidence is being generated.

Reduction of Progesterone Elevation at Trigger in Poor Responder Bologna' Criteria Patients After Controlled Ovarian Stimulation With Long Acting Standard Stimulation Protocol Compared With Conventional Daily Protocol: a Single Center Prospective Randomized Fase IV Trial

CompletedPH IVIRCCS San Raffaelen=1102024

Continuous Ovarian Stimulation in DUOSTIM Cycles.

CompletedPH IVInstituto Bernabeun=302023

An Efficacy and Safety Study of Corifollitropin Alfa Versus Daily Follitropin Beta for Controlled Ovarian Stimulation in Women 35-42 Years Old With a Body Weight ≥ 50 kg Undergoing IVF Treatment.

CompletedPH IVVietnam National Universityn=4002017

A Prospective Randomized Trial to Analyze the Effect of the Gonadotropin Administered During Control Ovarian Stimulation on Embryo Kinetics of Development

TerminatedPH IVIVI Madridn=2012016

Administration of Corifollitropin Alfa on Day 5 Versus Day 7 After Last Oral Contraceptive Pill in a GnRH (Gonadotropin-releasing Hormone ) Antagonist Protocol in Donors

CompletedPH IVFundacion Dexeusn=702016

Recent completions

Trials that read out recently, adding to the completed evidence base.

Reduction of Progesterone Elevation at Trigger in Poor Responder Bologna' Criteria Patients After Controlled Ovarian Stimulation With Long Acting Standard Stimulation Protocol Compared With Conventional Daily Protocol: a Single Center Prospective Randomized Fase IV Trial

CompletedPH IVIRCCS San Raffaelen=1102024

Continuous Ovarian Stimulation in DUOSTIM Cycles.

CompletedPH IVInstituto Bernabeun=302023

A Comparison Between Corifollitropin Alfa and Recombinant FSH for Follicular Recruitment in Women With Polycystic Ovaries Who Undergo IVM Treatment

CompletedPH IIIUniversitair Ziekenhuis Brusseln=1452022

A Phase III, Multi-Center, Open Label, Single-Group Trial to Investigate the Efficacy and Safety of MK-8962 (Corifollitropin Alfa) in Combination With Human Chorionic Gonadotropin (hCG) for Initiation or Restoration of Puberty as Assessed by Increased Testicular Volume in Adolescent Males 14 to <18 Years Old With Hypogonadotropic Hypogonadism (MK-8962-043)

CompletedPH IIIOrganon and Con=172020

Ovarian Response to Controlled Ovarian Stimulation Measured Through the Follicular Output Rate (FORT)

CompletedN/AHospital de Clinicas de Porto Alegren=3002019

Prospective Randomized Trial Comparing Corifollitropin-alfa Late Start (Day 4) vs. Corifollitropin-alfa Standard Start (Day 2) in Expected Poor, Normal and High-responders Undergoing IVF/ICSI

CompletedN/AUniversity of Turin, Italyn=1132018
References & data sources
  • RxNorm (U.S. National Library of Medicine) — drug identity
  • ClinicalTrials.gov — clinical trials
  • Regulatory event sources are credited in the Regulatory Timeline above.