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Drug

Lutropin alfa

Established medicine
ClassLuteinizing hormone/Choriogonadotropin receptor agonistResearchOngoing clinical research
Also known as Luveris, rLH, Lutropina alfa, Recombinant LH+2 more

Luveris, rLH, Lutropina alfa, Recombinant LH, Recombinant human luteinising hormone, Recombinant human luteinizing hormone.

RxNorm388084ChEMBLCHEMBL1201419ATCG03GA07UNII3JGY52XJNA
4
Active clinical trials
LHCGR
Primary target
1
Regulatory events
Latest activity
beta

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

Extended LH Administration (ELHA), a Strategy to Increase the Pool of Recruitable Antral Follicles: a Multicentric Randomized Trial

Clinical trial2025-11-01Primary completion · ClinicalTrials.gov

Pharmacodynamics and Safety of Human Recombinant Luteinising Hormone in Hypogonadotropic Hypogonadal Men

Clinical trial2025-01-18Primary completion · ClinicalTrials.gov

Endometrial Gene Expression Profiles During Ovarian Stimulation With Recombinant FSH With or Without the Addition of Recombinant LH in Genuine Poor Responders

Clinical trial2024-08-01Withdrawn · ClinicalTrials.gov

FSH and LH Versus FSH Alone for Ovarian Stimulation in Non-hormone Sensitive Onco-fertility Patients: an Exploratory Randomized Controlled Trial

Clinical trial2024-01-29Results expected Q4 2029 · ClinicalTrials.gov

Recombinant LH Supplementation Timing Strategies (From Day 1 or Day 6) to a Standard GnRH Agonist Long Protocol in Subsequent COS Cycle of Older Patients With Unexpected Poor or Suboptimal Ovarian Response

Clinical trial2022-12-30Primary completion · ClinicalTrials.gov

Hormonal Mechanisms of Sleep Restriction - Axis Study in Older Men and Postmenopausal Women

Clinical trial2022-07-24Primary completion · ClinicalTrials.gov

A Phase I, Open-label, Randomized, Three-period, Crossover, Single-center Trial to Assess the Bioequivalence of the Co-administration of 900 IU of Follitropin Alfa (Gonal-f) and 450 IU of Lutropin Alfa (Luveris) Versus the Fixed Combination of 900 IU Follitropin Alfa and 450 IU Lutropin Alfa in Pergoveris, Administered SC as Liquid and FD Formulation, in Pituitary Suppressed Healthy Premenopausal Female Chinese Participants

Clinical trial2022-05-28Completed · ClinicalTrials.gov

Hormonal Mechanisms of Sleep Restriction - Axis Study

Clinical trial2020-10-30Primary completion · ClinicalTrials.gov

Lutropin Alpha in the Middle of the Controlled Ovarian Stimulation Follicular Phase in Women With Reduced Ovarian Reserve: Comparative Study, in Phase II, With Parallel Control

Clinical trial2018-03-27Results posted · ClinicalTrials.gov

Reproductive Hormonal Alterations in Obesity, AIMS #1 & #2

Clinical trial2017-01-12Results posted · ClinicalTrials.gov

Comparison of Assisted Reproductive Technology (ART) Outcomes Between Two Protocols of Induction of Ovulation by Using Recombinant Luteinizing Hormone (rLH) and Recombinant Follicle Stimulating Hormone (rFSH) in Patients With Hypogonadotropic Hypogonadism

Clinical trial2015-12-01Primary completion · ClinicalTrials.gov

Approval: Luveris (EMA)

Regulatory2000-11-29EMA

Profile

Identifiers & mechanism

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

Canonical name
Lutropin alfa
Aliases & brands
LuverisrLHLutropina alfaRecombinant LHRecombinant human luteinising hormoneRecombinant human luteinizing hormone
RxNorm CUI
388084
ChEMBL ID
CHEMBL1201419
ATC codes
G03GA07
UNII
3JGY52XJNA
Primary mechanism
Luteinizing hormone/Choriogonadotropin receptor agonist
Regulatory jurisdictions
ema

Pharmacology & targets

1 target

Known molecular targets and mechanisms supported by curated pharmacology databases.

Lutropin-choriogonadotropic hormone receptor
LHCGR · P22888
AGONISTLuteinizing hormone/Choriogonadotropin receptor agonist

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
2000-11-29
Latest approval
2000-11-29
Authorities
EMA
Total events
1
emaEuropean Medicines Agency· 1 event
2000-11-29Approval
Approval: Luveris (EMA)
Indication: Luveris in association with a follicle-stimulating-hormone (FSH) preparation is recommended for the stimulation of follicular development in women with severe luteinising-hormone… Show full indication

Luveris in association with a follicle-stimulating-hormone (FSH) preparation is recommended for the stimulation of follicular development in women with severe luteinising-hormone (LH) and FSH deficiency. In clinical trials, these patients were defined by an endogenous serum LH level <1.2 IU/l.

Evidence ↗

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

Clinical trials

17 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
17
registered trials across all phases
LATEST COMPLETION 2022
4
Active studies
2
Recruiting
9
Late-stage (III+)
6
Completed
7
Discontinued
PHASE DISTRIBUTIONn = 17
Early Phase 11Phase 12Phase 25Phase 32Phase 45Phase N / A2

Late-stage studies

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

Endometrial Gene Expression Profiles During Ovarian Stimulation With Recombinant FSH With or Without the Addition of Recombinant LH in Genuine Poor Responders

WithdrawnPH IVCRG UZ Brussel2024

Comparison of Assisted Reproductive Technology (ART) Outcomes Between Two Protocols of Induction of Ovulation by Using Recombinant Luteinizing Hormone (rLH) and Recombinant Follicle Stimulating Hormone (rFSH) in Patients With Hypogonadotropic Hypogonadism

Unknown statusPH IVRoyan Instituten=902016

The Luveris® In Vitro Fertilization Trial: The Effect of Recombinant Luteinizing Hormone on Follicular Response, Oocyte Quality, and Pregnancy in In-Vitro Fertilization Treatment Cycles in Women Without Endogenous LH Activity.

TerminatedPH IVUniversity Reproductive Associatesn=142013

To Define the Individual Need of Exogenous LH During Ovarian Stimulation for Severe LH Suppressed Patients After Administration of a GnRH Antagonist

CompletedPH IVAssuta Hospital Systemsn=502013

Synchronization of Follicle Wave Emergence and Ovarian Stimulation in Women With a History of Poor Ovarian Response to Treatment

CompletedPH IVUniversity of Saskatchewann=802010

Recent completions

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

A Phase I, Open-label, Randomized, Three-period, Crossover, Single-center Trial to Assess the Bioequivalence of the Co-administration of 900 IU of Follitropin Alfa (Gonal-f) and 450 IU of Lutropin Alfa (Luveris) Versus the Fixed Combination of 900 IU Follitropin Alfa and 450 IU Lutropin Alfa in Pergoveris, Administered SC as Liquid and FD Formulation, in Pituitary Suppressed Healthy Premenopausal Female Chinese Participants

CompletedPH IMerck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germanyn=722022

To Define the Individual Need of Exogenous LH During Ovarian Stimulation for Severe LH Suppressed Patients After Administration of a GnRH Antagonist

CompletedPH IVAssuta Hospital Systemsn=502013

Reproductive Hormonal Alterations in Obesity, AIMS #1 & #2

CompletedN/AUniversity of Colorado, Denvern=622013

Synchronization of Follicle Wave Emergence and Ovarian Stimulation in Women With a History of Poor Ovarian Response to Treatment

CompletedPH IVUniversity of Saskatchewann=802010

Lutropin Alpha in the Middle of the Controlled Ovarian Stimulation Follicular Phase in Women With Reduced Ovarian Reserve: Comparative Study, in Phase II, With Parallel Control

CompletedPH IIMerck KGaA, Darmstadt, Germanyn=1312006

Clinical Trial on Application of Injectable Recombinant Human Luteinizing Hormone (Luveris®) in the Treatment of Chinese Female Patients With Hypogonadotropic Hypogonadism: A Multi-center, Open, Prospective Drug Clinical Trial for Registration

CompletedPH IIIMerck KGaA, Darmstadt, Germanyn=312005
References & data sources
  • RxNorm (U.S. National Library of Medicine) — drug identity
  • ChEMBL (EMBL-EBI) & UniProt — pharmacology and targets
  • ClinicalTrials.gov — clinical trials
  • Regulatory event sources are credited in the Regulatory Timeline above.