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 |
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 |
---|---|---|---|---|---|
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
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