Overview

Lutropin alfa is a recombinant human luteinizing hormone produced in yeast with 2 subunits, alpha = 92 residues, beta = 121 residues. It is a heterodimeric glycoprotein made up of monomeric units. Lutropin alfa was the first and only recombinant human form of luteinizing hormone (LH) developed for use in the stimulation of follicular development. Its pharmacological action mimics the biological activity of endogenous LH; an acute rise of LH, or LH surge, in females triggers ovulation and the development of the corpous luteum. In males, LH stimulates Leydig cell to produce testosterone.

Indication

For treatment of infertility in women with hypothalamic or pituitary insufficiency (hypogonadotropic hypogonadism) and profound LH deficiency (LH <1.2 international units [IU]/L)

Associated Conditions

No associated conditions information available.

Research Report

Published: Aug 6, 2025

A Comprehensive Monograph on Lutropin alfa (r-hLH): From Molecular Design to Clinical Application and Regulatory Landscape

Section 1: Introduction and Executive Summary

1.1. Overview of Lutropin alfa

Lutropin alfa is a highly purified preparation of recombinant human luteinizing hormone (r-hLH), a critical glycoprotein hormone in human reproduction.[1] As a product of modern biotechnology, it represents a significant advancement over earlier gonadotropin preparations derived from human sources. It is engineered to be structurally and functionally identical to the native luteinizing hormone (LH) produced by the pituitary gland.[2] Its primary role in medicine is as a targeted therapeutic agent for specific subsets of female infertility, where it serves to replace or supplement deficient endogenous LH activity. The development of Lutropin alfa provided clinicians with a preparation of defined LH activity, characterized by a consistent isoform profile and high batch-to-batch reliability, thereby enabling more precise and predictable ovarian stimulation protocols.[4]

1.2. Core Therapeutic Rationale

Continue reading the full research report

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
FSH and LH Versus FSH Alone for Ovarian Stimulation in Non-hormone Sensitive Onco-fertility Patients	2024/01/29	NCT06227949	Phase 3	Not yet recruiting	Ellen Greenblatt
Effect of LH Supplementation on the Endometrial Gene Expression Profile in Poor Ovarian Responders	2022/06/06	NCT05405686	Phase 4	Withdrawn	CRG UZ Brussel
Pergoveris FD and Liquid China BE Study	2021/05/24	NCT04899193	Phase 1	Completed	Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
Rec-LH PD and Safety Profile in Hypogonadotropic Hypogonadism Men	2019/12/06	NCT04189133	Phase 2	Recruiting	Azienda Ospedaliero-Universitaria di Modena
Double Ovarian Stimulation as Accumulation Strategy for Older Infertile Patients With Suboptimal Ovarian Response	2018/01/17	NCT03400722	Phase 4	UNKNOWN	Nova Clinic, Russia
Bioequivalence Trial of Liquid Versus Freeze-Dried Pergoveris® in Pituitary Suppressed Healthy Premenopausal Female Subjects	2014/12/16	NCT02317809	Phase 1	Completed	Merck KGaA, Darmstadt, Germany
Efficacy of Pergoveris in Aged IVF Patients	2014/09/19	NCT02244866	Not Applicable	Completed	Vietnam National University
Comparison of Assisted Reproductive Technology (ART) Outcomes Between Two Protocols of Induction of Ovulation in Patients With Hypogonadotropic Hypogonadism	2014/05/16	NCT02140515	Phase 4	UNKNOWN	Royan Institute
Phase 3 Study to Evaluate the Efficacy and Safety of Pergoveris® in Assisted Reproductive Technology (ESPART)	2014/01/28	NCT02047227	Phase 3	Completed	Merck KGaA, Darmstadt, Germany
A Study to Evaluate Safety and Efficacy of Recombinant Human Luteinizing Hormone (r-hLH) Compared With Urinary Human Chorionic Gonadotrophin (u-hCG) to Trigger Ovulation in Infertile Women	2012/11/28	NCT01735422	Phase 2	Completed	Merck KGaA, Darmstadt, Germany

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
No FDA approvals found for this drug.

EMA Drug Approvals

Approved Product	Authorization Holder	Status	Issued Date
Pergoveris	Merck Europe B.V.,Gustav Mahlerplein 102,Ito Toren,1082 MA Amsterdam,The Netherlands	Authorised	6/25/2007
Pergoveris	Merck Europe B.V.,Gustav Mahlerplein 102,Ito Toren,1082 MA Amsterdam,The Netherlands	Authorised	6/25/2007
Luveris	Merck Europe B.V.,Gustav Mahlerplein 102,Ito Toren,1082 MA Amsterdam,The Netherlands	Authorised	11/29/2000

HSA Drug Approvals

Approved Product	Manufacturer	Approval Number	Dosage Form	Strength	Approval Date
LUVERIS FOR INJECTION 75 iu/vial (Revised formula)	Merck Serono SA	SIN12507P	INJECTION, POWDER, FOR SOLUTION	75 IU/vial	1/30/2004
Pergoveris Powder and Solvent for Solution for Injection 150iu/75iu	Merck Serono S.A. (Drug product and solvent manufacturer)	SIN13990P	INJECTION, POWDER, FOR SOLUTION	75 IU	7/18/2011
PERGOVERIS SOLUTION FOR INJECTION IN PRE-FILLED PEN (300 IU + 150 IU)/0.48 mL	Merck Serono S.p.A	SIN15711P	INJECTION, SOLUTION	150 IU/0.48ml	6/11/2019
PERGOVERIS SOLUTION FOR INJECTION IN PRE-FILLED PEN (900 IU + 450 IU)/1.44 mL	Merck Serono S.p.A	SIN15713P	INJECTION, SOLUTION	450 IU/1.44ml	6/11/2019
PERGOVERIS SOLUTION FOR INJECTION IN PRE-FILLED PEN (450 IU + 225 IU)/0.72 mL	Merck Serono S.p.A	SIN15712P	INJECTION, SOLUTION	225 IU/0.72ml	6/11/2019

NMPA Drug Approvals

Approved Product	Company	Approval Number	Drug Type	Dosage Form	Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

Approved Product	Registration No.	Company	Licence No.	Strength	Registration Date
No PPB approvals found for this drug.

TGA Drug Approvals

Approved Product	ARTG ID	Sponsor	Registration Type	Status	Registration Date
PERGOVERIS follitropin alfa (rch) /lutropin alfa (rch) 300 IU/150 IU in 0.48 mL solution for injection cartridge pre-assembled in a pen	288927	Merck Healthcare Pty Ltd	Medicine	A	6/29/2018
PERGOVERIS follitropin alfa (rch) /lutropin alfa (rch) 900 IU/450 IU in 1.44 mL solution for injection cartridge pre-assembled in a pen	288929	Merck Healthcare Pty Ltd	Medicine	A	6/29/2018
PERGOVERIS follitropin alfa (rch) /lutropin alfa (rch) 450 IU/225 IU in 0.72 mL solution for injection cartridge pre-assembled in a pen	288928	Merck Healthcare Pty Ltd	Medicine	A	6/29/2018
LUVERIS lutropin alfa (rch) 75IU powder for injection vial with diluent vial	95042	Merck Healthcare Pty Ltd	Medicine	A	3/24/2003
PERGOVERIS follitropin alfa (rch) / lutropin alfa (rch) powder for injection vial with diluent vial	152797	Merck Healthcare Pty Ltd	Medicine	A	11/19/2009

Health Canada Drug Approvals

Approved Product	Company	DIN	Dosage Form	Strength	Market Date
PERGOVERIS	emd serono, a division of emd inc., canada	02445301	Powder For Solution , Kit - Subcutaneous	75 UNIT / VIAL	10/22/2015
LUVERIS	emd serono, a division of emd inc., canada	02339757	Solution - Subcutaneous	450 UNIT / 0.72 ML	N/A
PERGOVERIS	emd serono, a division of emd inc., canada	02470667	Solution - Subcutaneous	450 UNIT / 1.44 ML	10/29/2021
PERGOVERIS	emd serono, a division of emd inc., canada	02470640	Solution - Subcutaneous	150 UNIT / 0.48 ML	10/21/2021
PERGOVERIS	emd serono, a division of emd inc., canada	02470659	Solution - Subcutaneous	225 UNIT / 0.72 ML	10/29/2021
LUVERIS	emd serono, a division of emd inc., canada	02269066	Powder For Solution - Subcutaneous	75 UNIT / VIAL	6/28/2005

CIMA AEMPS Drug Approvals

Approved Product	Company	Registration Number	Pharmaceutical Form	Prescription Type	Status
LUVERIS 75 UI, POLVO Y DISOLVENTE PARA SOLUCION INYECTABLE	Merck Europe B.V.	00155006	POLVO Y DISOLVENTE PARA SOLUCIÓN INYECTABLE	Diagnóstico Hospitalario	Commercialized
PERGOVERIS 150 UI/75 UI POLVO Y DISOLVENTE PARA SOLUCION INYECTABLE	Merck Europe B.V.	07396001	POLVO Y DISOLVENTE PARA SOLUCIÓN INYECTABLE	Diagnóstico Hospitalario	Commercialized
PERGOVERIS (450 UI + 225 UI)/0,72 ML SOLUCION INYECTABLE EN PLUMA PRECARGADA	Merck Europe B.V.	107396005	SOLUCIÓN INYECTABLE	Diagnóstico Hospitalario	Commercialized
PERGOVERIS 150 UI/75 UI POLVO Y DISOLVENTE PARA SOLUCION INYECTABLE	Merck Europe B.V.	107396002	POLVO Y DISOLVENTE PARA SOLUCIÓN INYECTABLE	Diagnóstico Hospitalario	Commercialized
PERGOVERIS (900 UI + 450 UI)/1,44 ML SOLUCION INYECTABLES EN PLUMA PRECARGADA	Merck Europe B.V.	107396006	SOLUCIÓN INYECTABLE	Diagnóstico Hospitalario	Commercialized
PERGOVERIS (300 UI + 150 UI)/0,48 ML SOLUCION INYECTABLE EN PLUMA PRECARGADA	Merck Europe B.V.	107396004	SOLUCIÓN INYECTABLE EN PLUMA PRECARGADA	Diagnóstico Hospitalario	Commercialized
PERGOVERIS 150 UI/75 UI POLVO Y DISOLVENTE PARA SOLUCION INYECTABLE	Merck Europe B.V.	07396003	POLVO Y DISOLVENTE PARA SOLUCIÓN INYECTABLE	Diagnóstico Hospitalario	Commercialized

Philippines FDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Philippines FDA approvals found for this drug.

Saudi SFDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Saudi SFDA approvals found for this drug.

Malaysia NPRA Drug Approvals

Approved Product	Company	Registration Number	Dosage Form	Strength	Approval Date
No Malaysia NPRA approvals found for this drug.

UK EMC Drug Information

Medicine Name	MA Holder	MA Number	Pharmaceutical Form	Active Ingredient	Authorization Date
No UK EMC drug information found for this drug.

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