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Follitropin

Generic Name
Follitropin
Brand Names
Bemfola, Follistim, Gonal F, Gonal-F, Menopur, Ovaleap, Pergoveris, Puregon, GONAL-f, Rekovelle
Drug Type
Biotech
CAS Number
146479-72-3
Unique Ingredient Identifier
2M2GGL7HUP

Overview

Follitropin is a human follicle stimulating hormone (FSH) preparation of recombinant DNA origin, which consists of two non-covalently linked, non-identical glycoproteins designated as the alpha- and beta- subunits. The alpha- and beta- subunits have 92 and 111 amino acids. The alpha subunit is glycosylated at Asn 51 and Asn 78 while the beta subunit is glycosylated at Asn 7 and Asn 24. Follitropin beta is produced in genetically engineered Chinese hamster cell lines (CHO). The nomenclature “beta” differentiates it from another recombinant human FSH product that was marketed earlier as follitropin alpha. Follitropin is important in the development of follicles produced by the ovaries. Given by subcutaneous injection, it is used in combination with human chorionic gonadotropin (hCG) to assist in ovulation and fertility. Follitropin may also be used to cause the ovary to produce several follicles, which can then be harvested for use in gamete intrafallopian transfer (GIFT) or in vitro fertilization (IVF). Numerous physio-chemical tests and bioassays indicate that follitropin beta and follitropin alpha are indistinguishable. However, a more recent study showed there is may be a slight clinical difference, with the alpha form tending towards a higher pregnancy rate and the beta form tending towards a lower pregnancy rate, but with significantly higher estradiol (E2) levels. Structural analysis shows that the amino acid sequence of follitropin beta is identical to that of natural human follicle stimulating hormone (FSH). Further, the ogliosaccharide side chains are very similar, but not completely identical to that of natural FSH. However, these small differences do not affect the bioactivity compared to natural FSH.

Indication

In women having been diagnosed with primary ovarian failure, it is used in combination with human chorionic gonadotropin (hCG) to assist in ovulation and fertility. In men with hypogonadotrophic hypogonadism, it is used to induce spermatogenesis. Follitropin may also be used to cause the ovary to produce several follicles, which can then be harvested for use in gamete intrafallopian transfer (GIFT) or in vitro fertilization (IVF).

Associated Conditions

No associated conditions information available.

Research Report

Published: Jul 23, 2025

Comprehensive Monograph on Follitropin (rhFSH)

Section 1: Executive Summary

Follitropin is a recombinant form of human Follicle-Stimulating Hormone (FSH), a cornerstone gonadotropin in the therapeutic management of infertility in both men and women.[1] As a biotechnologically derived therapeutic, it represents a significant advancement over earlier gonadotropins extracted from human urine, offering superior purity, batch-to-batch consistency, and a more favorable safety profile by eliminating the risk of urinary protein contaminants.[2] The primary function of follitropin is to act as an agonist of the FSH receptor, thereby stimulating ovarian follicular development in females and spermatogenesis in males.[1] Its principal clinical applications are in ovulation induction for anovulatory women, controlled ovarian stimulation for Assisted Reproductive Technologies (ART) such as in vitro fertilization (IVF), and the treatment of male hypogonadotropic hypogonadism.[5]

The continued development of follitropin has yielded distinct molecular variants—alfa, beta, and delta—which are produced in different recombinant cell lines. This variation in manufacturing results in unique glycosylation patterns that directly influence their pharmacokinetic profiles and, consequently, their clinical dosing strategies.[1] This evolution has culminated in the development of sophisticated, personalized dosing algorithms for the newest variant, follitropin delta, which are based on patient-specific biomarkers like Anti-Müllerian Hormone (AMH) and body weight to optimize the balance between efficacy and safety.[10]

Continue reading the full research report

Clinical Trials

Title
Posted
Study ID
Phase
Status
Sponsor
2025/03/07
Phase 1
Not yet recruiting
2025/01/31
Not Applicable
Recruiting
2025/01/16
Phase 1
Completed
West China Second University Hospital
2024/07/22
Phase 1
Recruiting
2024/07/01
Not Applicable
Recruiting
Andros Day Surgery Clinic
2024/06/20
Phase 1
Recruiting
2024/05/16
Phase 1
Recruiting
2023/12/19
Phase 4
Not yet recruiting
2023/12/18
Phase 3
Completed
2023/05/24
N/A
Active, not recruiting
Clinique Ovo

FDA Drug Approvals

Approved Product
Manufacturer
NDC Code
Route
Strength
Effective Date
Dr. Donna Restivo DC
62185-0050
ORAL
12 [hp_C] in 1 mL
5/23/2025
Organon LLC
78206-131
SUBCUTANEOUS
900 [iU] in 1.08 mL
7/24/2023
Merck Sharp & Dohme LLC
0052-0316
SUBCUTANEOUS
650 [iU] in 0.78 mL
11/17/2023
EMD Serono, Inc.
44087-1116
SUBCUTANEOUS
450 [iU] in 0.75 mL
2/19/2020
EMD Serono, Inc.
44087-1117
SUBCUTANEOUS
900 [iU] in 1.5 mL
2/19/2020
Organon LLC
78206-130
SUBCUTANEOUS
600 [iU] in 0.72 mL
7/24/2023
EMD Serono, Inc.
44087-1115
SUBCUTANEOUS
300 [iU] in 0.5 mL
2/19/2020
Merck Sharp & Dohme LLC
0052-0326
SUBCUTANEOUS
975 [iU] in 1.17 mL
11/17/2023
Merck Sharp & Dohme LLC
0052-0313
SUBCUTANEOUS
350 [iU] in 0.42 mL
11/17/2023
Organon LLC
78206-129
SUBCUTANEOUS
300 [iU] in 0.36 mL
7/24/2023

HSA Drug Approvals

Approved Product
Manufacturer
Approval Number
Dosage Form
Strength
Approval Date
REKOVELLE SOLUTION FOR INJECTION IN A PRE-FILLED PEN 72MCG/2.16ML
SIN15651P
INJECTION, SOLUTION
72.0 mcg
3/25/2019
REKOVELLE SOLUTION FOR INJECTION IN A PRE-FILLED PEN 36MCG/1.08ML
SIN15652P
INJECTION, SOLUTION
36.0 mcg
3/25/2019
Puregon solution for injection 900IU/1.08ml
SIN14474P
INJECTION
833 IU/ml
12/30/2013
PUREGON SOLUTION FOR INJECTION 300 iu/0.36 ml
SIN12185P
INJECTION
833IU/ml
2/6/2003
Gonal-f 900 iu/1.5 ml (66 mcg/1.5 ml) Solution for Injection in a pre-filled pen
SIN13024P
INJECTION, SOLUTION
66.69 mcg
8/18/2004
GONAL-F INJECTION 1050 iu (77 mcg)/1.75 ml
SIN11779P
INJECTION, POWDER, FOR SOLUTION
600 iu/ml
1/18/2002
Gonal-f 450 iu/0.75 ml (33 mcg/0.75 ml) Solution for Injection in a pre-filled pen
SIN13022P
INJECTION, SOLUTION
33.34 mcg
8/18/2004
Gonal-f 150 IU/0.25 ml (11 micrograms/0.25 ml) Solution for Injection in pre-filled pen
SIN16473P
INJECTION, SOLUTION
11.115 μg/0.25ml
4/11/2022
GONAL-F FOR INJECTION 75 iu (5.5 mcg)/vial
SIN12450P
INJECTION, POWDER, FOR SOLUTION
75IU (5.5mcg) /vial
10/22/2003
Puregon solution for injection 600IU/0.72ml
SIN14473P
INJECTION
833 IU/ml
12/30/2013

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
GONAL-F PRE-FILLED PEN FOR INJ 450IU/0.75ML
N/A
N/A
N/A
7/1/2005

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
Medicine
A
6/29/2018
GONAL-F follitropin alfa (rch) 450 IU (retrievable dose) multidose powder for injection vial and diluent pre-filled syringe
96114
Medicine
A
8/21/2003
PUREGON follitropin beta (rch) 300 IU solution for injection cartridge
76436
Medicine
A
11/15/2001
PUREGON follitropin beta (rch) 150 IU solution for injection cartridge
116842
Medicine
A
10/10/2005
PUREGON follitropin beta (rch) 900 IU solution for injection cartridge
116843
Medicine
A
10/10/2005
RECAGON follitropin beta (rch) 900 IU solution for injection cartridge
393993
Medicine
A
10/28/2022
AFOLIA follitropin alfa (rch) 450 IU/0.75 mL (33 microgram) solution for injection cartridge in a pre-filled pen
262649
Medicine
A
11/27/2015
GONAL-F follitropin alfa (rch) 300IU/0.48mL (21.84microgram) solution for injection cartridge, pre-assembled in a pen
96230
Medicine
A
12/1/2003
GONAL-F follitropin alfa (rch) 75 IU (5.46 microgram) powder for injection vial with diluent vial
91563
Medicine
A
4/8/2003
BEMFOLA follitropin alfa (rch) 150 IU/0.25 mL (11 microgram) solution for injection cartridge in a pre-filled pen
231046
Medicine
A
11/27/2015

Health Canada Drug Approvals

Approved Product
Company
DIN
Dosage Form
Strength
Market Date
GONAL-F
emd serono, a division of emd inc., canada
02248156
Powder For Solution - Subcutaneous ,  Intramuscular
33 MCG / VIAL
12/30/2003
REKOVELLE
Ferring Inc
02487462
Solution - Subcutaneous
12 MCG / 0.36 ML
11/1/2019
PERGOVERIS
emd serono, a division of emd inc., canada
02445301
Powder For Solution ,  Kit - Subcutaneous
150 UNIT / VIAL
10/22/2015
PUREGON
Merck Canada Inc
02242439
Solution - Subcutaneous ,  Intramuscular
50 UNIT / 0.5 ML
10/24/2001
REKOVELLE
Ferring Inc
02487470
Solution - Subcutaneous
36 MCG / 1.08 ML
11/1/2019
GONAL-F
emd serono, a division of emd inc., canada
02231464
Powder For Solution - Intramuscular ,  Subcutaneous
75 UNIT / VIAL
7/25/1997
GONAL-F
emd serono, a division of emd inc., canada
02248157
Powder For Solution - Intramuscular ,  Subcutaneous
77 MCG / VIAL
12/30/2003
GONAL-F PEN
emd serono, a division of emd inc., canada
02270390
Solution - Subcutaneous
450 UNIT / 0.75 ML
9/6/2005
PUREGON 100 I.U.
organon canada ltd ltee
02231656
Liquid ,  Powder For Solution - Subcutaneous ,  Intramuscular
100 UNIT / KIT
10/8/1997
GONAL-F
emd serono, a division of emd inc., canada
02248154
Powder For Solution - Intramuscular ,  Subcutaneous
5.5 MCG / VIAL
12/29/2003

CIMA AEMPS Drug Approvals

Approved Product
Company
Registration Number
Pharmaceutical Form
Prescription Type
Status
GONAL-F 450 UI/0,72 ML SOLUCION INYECTABLE EN PLUMA PRECARGADA
95001034
SOLUCIÓN INYECTABLE EN PLUMA PRECARGADA
Diagnóstico Hospitalario
Commercialized
GONAL-F 300 UI/0,48 ML SOLUCION INYECTABLE EN PLUMA PRECARGADA
95001033
SOLUCIÓN INYECTABLE EN PLUMA PRECARGADA
Diagnóstico Hospitalario
Commercialized
GONAL-F 150 UI/0,24 ML SOLUCION INYECTABLE EN PLUMA PRECARGADA
95001036
SOLUCIÓN INYECTABLE EN PLUMA PRECARGADA
Diagnóstico Hospitalario
Commercialized
GONAL-F 1050 UI/1,75 ml POLVO Y DISOLVENTE PARA SOLUCION INYECTABLE
95001021
POLVO Y DISOLVENTE PARA SOLUCIÓN INYECTABLE
Diagnóstico Hospitalario
Commercialized
GONAL-F 75 UI POLVO Y DISOLVENTE PARA SOLUCION INYECTABLE
95001025
POLVO Y DISOLVENTE PARA SOLUCIÓN INYECTABLE
Diagnóstico Hospitalario
Not Commercialized
BEMFOLA 150UI/0,25ml solucion inyectable en pluma precargada
113909008
SOLUCIÓN INYECTABLE
Diagnóstico Hospitalario
Commercialized
REKOVELLE 72 MICROGRAMOS/2,16 ML SOLUCION INYECTABLE
1161150003
SOLUCIÓN INYECTABLE
Diagnóstico Hospitalario
Not Commercialized
PUREGON 600 UI/0,72 ML SOLUCION INYECTABLE
Organon N.V.
96008039
SOLUCIÓN INYECTABLE EN CARTUCHO
Diagnóstico Hospitalario
Commercialized
BEMFOLA 300 UI/0,50 ml solucion inyectable en pluma precargada
113909013
SOLUCIÓN INYECTABLE
Diagnóstico Hospitalario
Commercialized
Ovaleap 900 UI/1,5 ml solucion inyectable
113871003
SOLUCIÓN PARA PERFUSIÓN
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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