Overview
Lutropin alfa is a recombinant human luteinizing hormone produced in yeast with 2 subunits, alpha = 92 residues, beta = 121 residues. It is a heterodimeric glycoprotein made up of monomeric units. Lutropin alfa was the first and only recombinant human form of luteinizing hormone (LH) developed for use in the stimulation of follicular development. Its pharmacological action mimics the biological activity of endogenous LH; an acute rise of LH, or LH surge, in females triggers ovulation and the development of the corpous luteum. In males, LH stimulates Leydig cell to produce testosterone.
Indication
For treatment of infertility in women with hypothalamic or pituitary insufficiency (hypogonadotropic hypogonadism) and profound LH deficiency (LH <1.2 international units [IU]/L)
Associated Conditions
No associated conditions information available.
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2024/01/29 | Phase 3 | Not yet recruiting | Ellen Greenblatt | ||
2022/06/06 | Phase 4 | Withdrawn | CRG UZ Brussel | ||
2021/05/24 | Phase 1 | Completed | Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany | ||
2019/12/06 | Phase 2 | Recruiting | |||
2018/01/17 | Phase 4 | UNKNOWN | Nova Clinic, Russia | ||
2014/12/16 | Phase 1 | Completed | |||
2014/09/19 | Not Applicable | Completed | Vietnam National University | ||
2014/05/16 | Phase 4 | UNKNOWN | |||
2014/01/28 | Phase 3 | Completed | |||
2012/11/28 | Phase 2 | Completed |
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 |
|---|---|---|---|
Authorised | 6/25/2007 | ||
Authorised | 6/25/2007 | ||
Authorised | 11/29/2000 |
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| LUVERIS FOR INJECTION 75 iu/vial (Revised formula) | SIN12507P | INJECTION, POWDER, FOR SOLUTION | 75 IU/vial | 1/30/2004 | |
| Pergoveris Powder and Solvent for Solution for Injection 150iu/75iu | SIN13990P | INJECTION, POWDER, FOR SOLUTION | 75 IU | 7/18/2011 | |
| PERGOVERIS SOLUTION FOR INJECTION IN PRE-FILLED PEN (300 IU + 150 IU)/0.48 mL | SIN15711P | INJECTION, SOLUTION | 150 IU/0.48ml | 6/11/2019 | |
| PERGOVERIS SOLUTION FOR INJECTION IN PRE-FILLED PEN (900 IU + 450 IU)/1.44 mL | SIN15713P | INJECTION, SOLUTION | 450 IU/1.44ml | 6/11/2019 | |
| PERGOVERIS SOLUTION FOR INJECTION IN PRE-FILLED PEN (450 IU + 225 IU)/0.72 mL | SIN15712P | INJECTION, SOLUTION | 225 IU/0.72ml | 6/11/2019 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| Recombinant Human Lutropin alfa for Injection | 国药准字SJ20181004 | 生物制品 | 注射剂 | 10/10/2022 | |
| Recombinant Human Lutropin alfa for Injection | 国药准字SJ20181005 | 生物制品 | 注射剂 | 10/10/2022 |
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 |
|---|---|---|---|---|---|
| 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 | |
| PERGOVERIS follitropin alfa (rch) /lutropin alfa (rch) 900 IU/450 IU in 1.44 mL solution for injection cartridge pre-assembled in a pen | 288929 | Medicine | A | 6/29/2018 | |
| PERGOVERIS follitropin alfa (rch) /lutropin alfa (rch) 450 IU/225 IU in 0.72 mL solution for injection cartridge pre-assembled in a pen | 288928 | Medicine | A | 6/29/2018 | |
| LUVERIS lutropin alfa (rch) 75IU powder for injection vial with diluent vial | 95042 | Medicine | A | 3/24/2003 | |
| PERGOVERIS follitropin alfa (rch) / lutropin alfa (rch) powder for injection vial with diluent vial | 152797 | Medicine | A | 11/19/2009 |
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