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
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]
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 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
---|---|---|---|
Authorised | 3/26/2014 | ||
Authorised | 6/25/2007 | ||
Authorised | 6/25/2007 | ||
Authorised | 10/20/1995 | ||
Authorised | 12/12/2016 | ||
Authorised | 5/2/1996 | ||
Authorised | 9/27/2013 | ||
Authorised | 9/27/2013 |
HSA Drug Approvals
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
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. |
Help Us Improve
Your feedback helps us provide better drug information and insights.