Urofollitropin

Overview

Urofollitropin is a urinary-derived follicle-stimulating hormone (FSH) that is extracted and purified from human urine samples. It 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. Urofollitropin is typically used injected subcutaneously in combination with human chorionic gonadotropin (hCG) to induce ovulation. Urofollitropin 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).

Indication

For treatment of female infertility

Associated Conditions

No associated conditions information available.

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
Study on the Safety and Pharmacokinetics of LM001 and Gonal-F® in Healthy Women	2018/05/24	NCT03535103	Phase 1	UNKNOWN	Alphamab Jilin Co., Ltd.
FSH Treatment for Non-obstructive Azoospermic Patients	2014/10/27	NCT02275169	Phase 3	UNKNOWN	Azienda Sanitaria Locale Bari
FSH in GnRH-AntagoniST Controlled Ovarian Hyperstimulation Cycles (FAST)	2013/10/25	NCT01969201	Phase 4	Completed	IBSA Institut Biochimique SA
Evaluation of Efficacy and Safety of Highly Purified Urofollitropin for Ovulation Induction in Chinese Females	2013/08/15	NCT01923194	Phase 3	Completed	Ferring Pharmaceuticals
Evaluation of Efficacy and Safety of Highly Purified Urofollitropin in Chinese Females Undergoing an Assisted Reproductive Technology (ART) Program	2013/08/14	NCT01922193	Phase 3	Completed	Ferring Pharmaceuticals
Effect of a Higher Than Maximum 450IU Gonadotropin Dose in an In-vitro Fertilization Cycle	2009/09/03	NCT00971152	Phase 3	Completed	Clinique Ovo

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
No FDA approvals found for this drug.

EMA Drug Approvals

Approved Product	Authorization Holder	Status	Issued Date
No EMA approvals found for this drug.

HSA Drug Approvals

Approved Product	Manufacturer	Approval Number	Dosage Form	Strength	Approval Date
No HSA approvals found for this drug.

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
No PPB approvals found for this drug.

TGA Drug Approvals

Approved Product	ARTG ID	Sponsor	Registration Type	Status	Registration Date
No TGA approvals found for this drug.

Health Canada Drug Approvals

Approved Product	Company	DIN	Dosage Form	Strength	Market Date
METRODIN 75 I.U.	industria farmaceutica serono spa	00755613	Powder For Solution - Intramuscular	75 UNIT / AMP	12/31/1988
FERTINORM HP 75 - PWS DILUENT IM SC	emd serono, a division of emd inc., canada	02125404	Powder For Solution , Liquid - Subcutaneous , Intramuscular	75 UNIT / KIT	12/31/1994
FERTINORM HP 150 - PWS DILUENT IM SC	emd serono, a division of emd inc., canada	02125412	Liquid , Kit , Powder For Solution - Intramuscular , Subcutaneous	150 UNIT / VIAL	12/31/1994
BRAVELLE	Ferring Inc	02268140	Powder For Solution - Intramuscular , Subcutaneous	75 UNIT / VIAL	6/15/2005

CIMA AEMPS Drug Approvals

Approved Product	Company	Registration Number	Pharmaceutical Form	Prescription Type	Status
No CIMA AEMPS (Spain) approvals found for this drug.

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.

AI-Powered Research

Premium Access