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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.

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
Recombinant Human Follitropin for Injection
国药准字S20250018
生物制品
注射剂
4/30/2025
Recombinant Human Follitropin for Injection
国药准字S20210052
生物制品
注射剂
12/14/2021
Recombinant Human Follitropin for Injection
国药准字S20150007
生物制品
注射剂
5/6/2020
Recombinant Human Follitropin for Injection
国药准字SJ20181008
生物制品
注射剂
1/16/2023
Recombinant Human Follitropin Prefilled Syringe
国药准字S20240003
生物制品
注射剂
1/5/2024
Recombinant Human Follitropin Prefilled Syringe
国药准字S20258004
生物制品
注射剂
4/15/2025
Recombinant Human Follitropin Prefilled Syringe
国药准字SJ20210007
生物制品
注射剂
4/7/2021
Recombinant Human Follitropin Prefilled Syringe
国药准字SJ20210008
生物制品
注射剂
4/7/2021
Recombinant Human Follitropin Prefilled Syringe
国药准字S20240002
生物制品
注射剂
1/5/2024
Recombinant Human Follitropin Prefilled Syringe
国药准字SJ20160039
生物制品
注射剂
8/27/2021

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

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