Follitropin

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Identification

Summary

Follitropin is a form of recombinant human follicle stimulating hormone used to stimulate follicle development in women with primary ovarian hypogonadism and in men with hypogonadotropic hypogonadism.

Brand Names

Bemfola, Follistim, Gonal F, Gonal-F, Menopur, Ovaleap, Pergoveris, Puregon

Generic Name

Follitropin

DrugBank Accession Number

DB00066

Background

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.

Type

Biotech

Groups

Approved

Biologic Classification

Protein Based Therapies
Hormones

Protein Structure

Protein Chemical Formula: C₉₇₅H₁₅₁₃N₂₆₇O₃₀₄S₂₆
Protein Average Weight: 22672.9 Da

Sequences

>Alpha chain
APDVQDCPECTLQENPFFSQPGAPILQCMGCCFSRAYPTPLRSKKTMLVQKNVTSESTCC
VAKSYNRVTVMGGFKVENHTACHCSTCYYHKS

>Beta chain
NSCELTNITIAIEKEECRFCISINTTWCAGYCYTRDLVYKDPARPKIQKTCTFKELVYET
VRVPGCAHHADSLYTYPVATQCHCGKCDSDSTDCTVRGLGPSYCSFGEMKE

Download FASTA Format

Synonyms

Folitropina alfa
Folitropina beta
Folitropina delta
Follicle stimulating hormone
Follitrophin alfa
Follitrophin alpha
Follitrophin beta
Follitropin alfa
Follitropin alfa/beta
Follitropin alpha
Follitropin beta
Follitropin delta
Follitropin gamma
Follotropin recombinant
FSH
FSH alpha
FSH-a
FSH-b
FSH-beta
Recombinant human follicle stimulating hormone beta
Recombinant human follicle-stimulating hormone (r-HFSH)
rFSH-alpha

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Pharmacology

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).

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Associated Therapies

Contraindications & Blackbox Warnings

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Pharmacodynamics

Used for the treatment of female infertility, Follitropin beta or follicle stimulating hormone (FSH) stimulates ovarian follicular growth in women who do not have primary ovarian failure. FSH, the active component of Follitropin beta is the primary hormone responsible for follicular recruitment and development.

Mechanism of action

Follitropin is a recombinant form of endogenous follicle stimulating hormone (FSH). FSH binds to the follicle stimulating hormone receptor which is a G-coupled transmembrane receptor. Binding of the FSH to its receptor seems to induce phosphorylation and activation of the PI3K (Phosphatidylinositol-3-kinase) and Akt signaling pathway, which is known to regulate many other metabolic and related survival/maturation functions in cells.

Target	Actions	Organism
AFollicle-stimulating hormone receptor	agonist	Humans

Absorption

The absorption rate is the main driving force behind the pharmokinetics of Follitropin alpha as the rate of absorption was found to be slower than the elimination rate after administration subcutaneously and intramuscularly. The bioavailability is approximately 66-76%. The time to peak after subcutaneous injection in healthy volunteers was 8-16 hours in females and 11-20 hours in males.

Volume of distribution

8 L [female subjects following intravenous administration of a 300 IU dose]

Protein binding

Not Available

Metabolism

Not Available

Route of elimination

Via liver and kidneys.

Half-life

Circulation half life of 3-4 hours, elimination half life of 35-40 hours

Clearance

0.01 1*h-1kg-1 [European women with a single intramuscular dose of 300 IU]
0.01 1*h-1kg-1 [Japanese women with a single intramuscular dose of 300 IU]

Adverse Effects

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Toxicity

Headaches, ovarian cysts, nausea and upper respiratory tract infections occurred in more than 10% of women in clinical trials. In men, the most serious adverse events reported were testicular surgery for cryptorchidism which existed prestudy, hemoptysis, an infected pilonidal cyst, and lymphadenopathy associated with an Epstein-Barr viral infection. Other concerns include overstimulation of the ovaries, pulmonary and vascular complications and multiple births. Post-marketing reports revealed hypersensitivity reactions including anaphylactoid reactions and asthma. Follitropin is contraindicated in pregnant women. No studies have been done in nursing mothers.

Pathways

Not Available

Pharmacogenomic Effects/ADRs

Not Available

Interactions

Drug Interactions

This information should not be interpreted without the help of a healthcare provider. If you believe you are experiencing an interaction, contact a healthcare provider immediately. The absence of an interaction does not necessarily mean no interactions exist.

Drug	Interaction
Integrate drug-drug interactions in your software
Acalabrutinib	The therapeutic efficacy of Follitropin can be decreased when used in combination with Acalabrutinib.
Acebutolol	The risk or severity of adverse effects can be increased when Acebutolol is combined with Follitropin.
Acetohexamide	The therapeutic efficacy of Acetohexamide can be decreased when used in combination with Follitropin.
Afatinib	The therapeutic efficacy of Follitropin can be decreased when used in combination with Afatinib.
Aldesleukin	The therapeutic efficacy of Follitropin can be decreased when used in combination with Aldesleukin.

Food Interactions

No interactions found.

Products

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International/Other Brands

Cinnal-F

Brand Name Prescription Products

Name	Dosage	Strength	Route	Labeller	Marketing Start	Marketing End
Bemfola	Injection, solution	75 IU/0.125ml	Subcutaneous	Gedeon Richter Plc	2016-09-08	Not applicable
Bemfola	Injection, solution	450 IU/0.75ml	Subcutaneous	Gedeon Richter Plc	2016-09-08	Not applicable
Bemfola	Injection, solution	300 IU/0.50ml	Subcutaneous	Gedeon Richter Plc	2016-09-08	Not applicable
Bemfola	Injection, solution	75 IU/0.125ml	Subcutaneous	Gedeon Richter Plc	2016-09-08	Not applicable
Bemfola	Injection, solution	450 IU/0.75ml	Subcutaneous	Gedeon Richter Plc	2016-09-08	Not applicable

Mixture Products

Name	Ingredients	Dosage	Route	Labeller	Marketing Start	Marketing End
Follistim	Follitropin (75 [iU]/1mL) + Water (5 mL/5mL)	Kit	Intramuscular; Subcutaneous	Organon Italia S.R.L.	1997-09-29	2005-01-01
Humegon Inj 75 I.U.	Follitropin (75 unit / kit) + Luteinizing hormone (75 unit / kit) + Sodium chloride (.9 % / kit)	Liquid; Powder, for solution	Intramuscular	Organon Italia S.R.L.	1993-12-31	2006-08-17
MENOGON 75 IU LIYOFILIZE TOZ ICEREN AMPUL,5 ADET	Follitropin (75 iu) + Luteinizing hormone (75 iu)	Injection, powder, lyophilized, for solution	Intramuscular; Subcutaneous	Ferring Pharmaceuticals	2006-04-11	2024-06-03
MENOGON 75 IU Powder and Solvent for solution for Injection	Follitropin (75 IU) + Luteinizing hormone (75 IU)	Injection, powder, for solution	Intramuscular; Subcutaneous	Ferring S.P.A.	2020-09-08	2020-12-17
MENOPUR	Follitropin (75 IU/ml) + Luteinizing hormone (75 IU/ml)	Injection, powder, for solution	Intramuscular; Subcutaneous	Dipa Pharmalab Intersains	2016-10-12	2021-10-18

Chemical Identifiers

UNII: 2M2GGL7HUP
CAS number: 146479-72-3

References

General References

Goa KL, Wagstaff AJ: Follitropin alpha in infertility: a review. BioDrugs. 1998 Mar;9(3):235-60. [Article]

External Links

UniProt: P01225
Genbank: M16647
PubChem Substance: 46508818
RxNav: 227518
ChEMBL: CHEMBL1201692
Therapeutic Targets Database: DAP001028
PharmGKB: PA449693
RxList: RxList Drug Page
Drugs.com: Drugs.com Drug Page
Wikipedia: Follicle-stimulating_hormone

FDA label

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Clinical Trials

Clinical Trials Clinical Trial & Rare Diseases Add-on Data Package Explore 4,000+ rare diseases, orphan drugs & condition pairs, clinical trial why stopped data, & more. Preview package

Phase	Status	Purpose	Conditions	Count	Start Date	Why Stopped	100+ additional columns
Unlock 175K+ rows when you subscribe.View sample data
Not Available	Active Not Recruiting	Not Available	Infertility / IVF	1	somestatus	stop reason	just information to hide
Not Available	Active Not Recruiting	Diagnostic	Cancer / Infertility	1	somestatus	stop reason	just information to hide
Not Available	Completed	Not Available	Anovulatory cycle	1	somestatus	stop reason	just information to hide
Not Available	Completed	Not Available	Controlled Ovarian Stimulation	3	somestatus	stop reason	just information to hide
Not Available	Completed	Not Available	Fertility Disorders / Fertility Issues / Gynecologic Diseases / IVF / Reproductive Disorder / Reproductive Issues	1	somestatus	stop reason	just information to hide

Pharmacoeconomics

Manufacturers

Organon usa inc
Emd serono inc

Packagers

EMD Canada Inc.
Organon Pharmaceuticals
Vetter Pharma Fertigung GmbH and Co. KG

Dosage Forms

Form	Route	Strength
Injection, solution	Subcutaneous	150 IU/0.25ML
Injection, solution	Subcutaneous	225 IU/0.375ML
Injection, solution	Subcutaneous	225 IU/3.75ML
Injection, solution	Subcutaneous	300 IU/0.50ML
Injection, solution	Subcutaneous	75 IU/0.125ML
Solution	Subcutaneous	75 UI
Solution	Subcutaneous	150 IU
Solution	Subcutaneous	300 IU
Solution	Subcutaneous	75 IU
Kit	Intramuscular; Subcutaneous
Injection, solution	Intramuscular; Subcutaneous	150 [iU]/0.5mL
Injection, solution	Intramuscular; Subcutaneous	75 [iU]/0.5mL
Injection, solution	Subcutaneous	175 [iU]/0.210mL
Injection, solution	Subcutaneous	300 [iU]/0.36mL
Injection, solution	Subcutaneous	350 [iU]/0.42mL
Injection, solution	Subcutaneous	600 [iU]/0.72mL
Injection, solution	Subcutaneous	650 [iU]/0.78mL
Injection, solution	Subcutaneous	900 [iU]/1.08mL
Injection, solution	Subcutaneous	975 [iU]/1.17mL
Solution		150 iu/1vial
Injection, powder, for solution		1050 IU/1.75ml
Injection, powder, for solution		75 IU
Powder		75 iu/1vial
Solution	Subcutaneous	75 UI
Injection, powder, lyophilized, for solution	Subcutaneous	37.5 IU
Injection, powder, for solution	Parenteral; Subcutaneous	1050 IU/1.75ML
Injection, powder, for solution	Parenteral; Subcutaneous	150 IU
Injection, powder, for solution	Parenteral; Subcutaneous	300 IU/0.5ML
Injection, powder, for solution	Parenteral; Subcutaneous	37.5 IU
Injection, powder, for solution	Parenteral; Subcutaneous	450 IU/0.75ML
Injection, powder, for solution	Parenteral; Subcutaneous	75 IU
Injection, powder, for solution	Subcutaneous	1050 IU/1.75ml
Injection, powder, for solution	Subcutaneous	150 IU
Injection, powder, for solution	Subcutaneous	300 IU/0.5ml
Injection, powder, for solution	Subcutaneous	75 IU/ML
Injection; injection, solution	Subcutaneous	300 IU/0.5ml
Kit	Subcutaneous	1050 [iU]/2mL
Kit	Subcutaneous	450 [iU]/1mL
Powder, for solution	Intramuscular; Subcutaneous	1200 unit / vial
Powder, for solution	Intramuscular; Subcutaneous	150 unit / vial
Powder, for solution	Intramuscular; Subcutaneous	33 mcg / vial
Powder, for solution	Intramuscular; Subcutaneous	37.5 unit / vial
Powder, for solution	Intramuscular; Subcutaneous	5.5 mcg / vial
Powder, for solution	Intramuscular; Subcutaneous	75 unit / vial
Powder, for solution	Intramuscular; Subcutaneous	77 mcg / vial
Injection, powder, lyophilized, for solution	Subcutaneous	1050 iu/1.75ml
Injection	Subcutaneous	150 iu
Injection, solution	Subcutaneous	300 iu/0.5ml
Injection, solution	Subcutaneous	22.23 mcg
Solution		300 iu/0.5ml
Injection	Subcutaneous	37.5 iu
Injection, solution	Subcutaneous	450 iu/0.75ml
Injection, powder, lyophilized, for solution	Subcutaneous	450 iu/0.75ml
Injection, solution	Subcutaneous	33.34 mcg
Solution		450 iu/0.75ml
Injection, powder, lyophilized, for solution	Subcutaneous	75 iu
Injection, solution	Subcutaneous	66.69 mcg
Injection, solution	Subcutaneous	900 iu/1.5ml
Solution		900 iu/1.5ml
Injection, powder, for solution	Subcutaneous	75 IU
Injection, powder, for solution	Subcutaneous	600 iu/ml
Solution	Subcutaneous	300 unit / 0.5 mL
Solution	Subcutaneous	450 unit / 0.75 mL
Solution	Subcutaneous	900 unit / 1.5 mL
Kit	Subcutaneous	75 [iU]/1mL
Injection, solution	Subcutaneous	300 [iU]/0.5mL
Injection, solution	Subcutaneous	450 [iU]/0.75mL
Injection, solution	Subcutaneous	900 [iU]/1.5mL
Injection, solution	Subcutaneous	150 [iU]/0.25mL
Injection, powder, for solution	Subcutaneous	450 IU/0.75ml
Injection, solution	Subcutaneous	22 mcg/0.5ml
Liquid; powder, for solution	Intramuscular
Injection	Subcutaneous
Injection, powder, lyophilized, for solution	Subcutaneous
Injection, powder, lyophilized, for solution	Intramuscular; Subcutaneous
Injection, powder, for solution	Intramuscular; Subcutaneous
Powder, for solution	Intramuscular
Injection, powder, for solution; injection, solution	Subcutaneous
Kit; powder, for solution	Subcutaneous
Powder	Parenteral; Subcutaneous
Solution	Subcutaneous
Injection, powder, for solution	Subcutaneous
Injection, powder, for solution	Subcutaneous	150 IU
Injection, solution	Subcutaneous	300 IU/0.48ml
Injection, solution	Subcutaneous	450 IU/0.72ml
Injection, solution	Subcutaneous	900 IU/1.44ml
Injection, solution	Intramuscular; Subcutaneous	100 IU/0.5ML
Injection, solution	Intramuscular; Subcutaneous	150 IU/0.5ML
Injection, solution	Intramuscular; Subcutaneous	200 IU/0.5ML
Injection, solution	Intramuscular; Subcutaneous	225 IU/0.5ML
Injection, solution	Intramuscular; Subcutaneous	250 IU/0.5ML
Injection, solution	Intramuscular; Subcutaneous	300 IU/0.36ML
Injection, solution	Intramuscular; Subcutaneous	50 IU/0.5ML
Injection, solution	Intramuscular; Subcutaneous	600 IU/0.72ML
Injection, solution	Intramuscular; Subcutaneous	75 IU/0.5ML
Injection, solution	Subcutaneous	150 IU/0.18mL
Injection, solution	Subcutaneous	300 IU/0.36mL
Injection, solution	Subcutaneous	900 IU/1.08ml
Solution		833 iu/1ml
Solution	Intramuscular; Subcutaneous	100 unit / 0.5 mL
Solution	Intramuscular; Subcutaneous	100 IU/0.5ml
Solution	Intramuscular; Subcutaneous	150 IU/0.5ml
Solution	Intramuscular; Subcutaneous	50 IU/0.5ml
Solution	Intramuscular; Subcutaneous	50 unit / 0.5 mL
Solution	Intramuscular; Subcutaneous	75 IU/0.5ml
Solution	Parenteral	150.000 UI
Solution	Subcutaneous	833 unit / mL
Powder, for solution; solution	Intramuscular; Subcutaneous	737 unit / cartridge
Injection, powder, lyophilized, for solution	Parenteral	100 IU
Injection, powder, lyophilized, for solution	Parenteral	150 IU
Solution	Parenteral	400 IU
Solution	Intramuscular; Subcutaneous	300 IU/0.36ml
Injection, solution		300 iu/0.36ml
Liquid; powder, for solution	Intramuscular; Subcutaneous
Injection, powder, for suspension	Parenteral	50 IU
Solution	Intramuscular; Subcutaneous	600 IU/0.72ml
Injection, solution		600 iu/0.72ml
Injection, powder, lyophilized, for solution	Parenteral	75 IU
Solution	Parenteral	75 IU
Injection, solution		900 iu/1.08ml
Solution	Intramuscular; Subcutaneous	900 IU/1.08ml
Injection	Intramuscular; Subcutaneous	100 iu/0.5ml
Injection	Subcutaneous	833 IU/ml
Injection	Intramuscular; Subcutaneous	50 iu/0.5ml
Injection, solution	Subcutaneous	600 IU/0.72ml
Injection, solution	Subcutaneous	833 IU/ml
Solution	Intramuscular; Subcutaneous	100 IU
Solution	Intramuscular; Subcutaneous	50 IU
Injection, solution		72 mcg/2.16ml
Injection, solution	Cutaneous; Parenteral	36 MCG/1.08ML
Injection, solution	Cutaneous; Parenteral	72 MCG/2.16ML
Injection, solution	Intramuscular; Subcutaneous	12 MCG/0.36ML
Injection, solution	Intramuscular; Subcutaneous	36 MCG/1.08ML
Injection, solution	Subcutaneous	12 ?g/0.36ml
Injection, solution	Subcutaneous	36 ?g/1.08ml
Injection, solution	Subcutaneous	72 ?g/2.16ml
Solution	Subcutaneous	12 mcg / 0.36 mL
Solution	Subcutaneous	12.000 mcg
Solution	Subcutaneous	36 mcg / 1.08 mL
Solution	Subcutaneous	72 mcg / 2.16 mL
Injection, solution	Subcutaneous
Injection, solution	Subcutaneous	12.0 mcg
Injection, solution	Subcutaneous	36.0 mcg
Injection, solution	Subcutaneous	72.0 mcg
Solution	Subcutaneous	33.3 mcg
Solution		75 IU/0.15ml
Injection, solution		150 iu/1ml
Injection, solution		75 iu/1ml
Injection, solution	Subcutaneous
Solution		100 iu/0.5ml

Prices

Unit description	Cost	Unit
Gonal-f rff 900 unit pen	1409.62USD	ml
Follistim AQ 900unt/1.08ml Solution 1 Cartridge = 1.17ml	1366.71USD	cartridge
Follistim AQ 600unt/0.72ml Solution 0.78ml Cartridge	911.14USD	cartridge
Gonal-f 450 unit Solution Vial	733.0USD	vial
Gonal-f rff 450 unit pen	704.81USD	pen
Gonal-f rff 300 unit pen	469.87USD	pen
Follistim AQ 300unt/0.36ml Solution 0.42ml Cartridge	455.57USD	cartridge
Follistim aq 300 unit cartridge	438.05USD	cartridge
Follistim aq 150 unit vial	219.02USD	vial
Gonal-f rff 75 unit vial	117.47USD	vial
Follistim aq 75 unit vial	109.51USD	vial

DrugBank does not sell nor buy drugs. Pricing information is supplied for informational purposes only.

Patents

Patent Number	Pediatric Extension	Approved	Expires (estimated)
US5270057	No	1993-12-14	2011-03-20
CA2037884	No	2003-10-21	2011-03-08
US7563763	No	2009-07-21	2019-08-23
US5929028	No	1999-07-27	2018-01-14
US7446090	No	2008-11-04	2019-08-23
US7741268	No	2010-06-22	2024-04-02

Properties

State

Liquid

Experimental Properties

Property	Value	Source
melting point (°C)	55 °C	Forastieri, H., Ingham, K.C. J. Biol. Chem. 257:7976-7981 (1982)
hydrophobicity	-0.330	Not Available
isoelectric point	7.50	Not Available

Targets

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insights and accelerate drug research.

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Details1. Follicle-stimulating hormone receptor

Kind: Protein
Organism: Humans
Pharmacological action: Yes
Actions: Agonist

General Function: G protein-coupled receptor for follitropin, the follicle-stimulating hormone (PubMed:11847099, PubMed:24058690, PubMed:24692546). Through cAMP production activates the downstream PI3K-AKT and ERK1/ERK2 signaling pathways (PubMed:24058690)
Specific Function: follicle-stimulating hormone receptor activity
Gene Name: FSHR
Uniprot ID: P23945
Uniprot Name: Follicle-stimulating hormone receptor
Molecular Weight: 78237.04 Da

References

Layman LC: Mutations in the follicle-stimulating hormone-beta (FSH beta) and FSH receptor genes in mice and humans. Semin Reprod Med. 2000;18(1):5-10. [Article]
Leng N, Dattatreyamurty B, Reichert LE Jr: Identification of amino acid residues 300-315 of the rat FSH receptor as a hormone binding domain: evidence for its interaction with specific regions of FSH beta-subunit. Biochem Biophys Res Commun. 1995 May 16;210(2):392-9. [Article]
Santa Coloma TA, Dattatreyamurty B, Reichert LE Jr: A synthetic peptide corresponding to human FSH beta-subunit 33-53 binds to FSH receptor, stimulates basal estradiol biosynthesis, and is a partial antagonist of FSH. Biochemistry. 1990 Feb 6;29(5):1194-200. [Article]
Dattatreyamurty B, Reichert LE Jr: Identification of regions of the follitropin (FSH) beta-subunit that interact with the N-terminus region (residues 9-30) of the FSH receptor. Mol Cell Endocrinol. 1993 May;93(1):39-46. [Article]
Lindau-Shepard B, Roth KE, Dias JA: Identification of amino acids in the C-terminal region of human follicle-stimulating hormone (FSH) beta-subunit involved in binding to human FSH receptor. Endocrinology. 1994 Sep;135(3):1235-40. [Article]
Goa KL, Wagstaff AJ: Follitropin alpha in infertility: a review. BioDrugs. 1998 Mar;9(3):235-60. [Article]
Chen X, Ji ZL, Chen YZ: TTD: Therapeutic Target Database. Nucleic Acids Res. 2002 Jan 1;30(1):412-5. [Article]

Drug created at June 13, 2005 13:24 / Updated at October 10, 2024 16:15

Follitropin

Identification

Pharmacology

Interactions

Products

Categories

Chemical Identifiers

References

Clinical Trials

Clinical Trial & Rare Diseases Add-on Data Package

Pharmacoeconomics

Properties

Targets

References