Leuprolide
Camcevi, Eligard, Fensolvi, Leuprolide, Lupaneta Pack, Lupron (leuprolide) is a protein pharmaceutical. Leuprolide was first approved as Lupron on 1985-04-09. It is used to treat breast neoplasms, endometrial neoplasms, endometriosis, infertility, and leiomyoma amongst others in the USA. The pharmaceutical is active against gonadotropin-releasing hormone receptor.
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Commercial
Therapeutic Areas
Trade Name
FDA
EMA
Camcevi, Eligard, Fensolvi, Leuprolide, Leuprolide for depot suspension, Lupron depot, Lupron depot-ped (discontinued: Leuprolide, Lupron, Lupron depot, Lupron depot-ped, Viadur)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Leuprolide acetate
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| LUPRON DEPOT | AbbVie | N-019732 RX | 1989-01-26 | 1 products, RLD, RS |
| LUPRON DEPOT | AbbVie | N-020011 RX | 1995-10-26 | 1 products, RLD, RS |
| LUPRON DEPOT | AbbVie | N-020517 RX | 1995-12-22 | 3 products, RLD |
| LUPRON DEPOT | AbbVie | N-020708 RX | 1997-03-07 | 1 products, RLD, RS |
| LUPRON DEPOT-PED KIT | AbbVie | N-020263 RX | 1993-04-16 | 6 products, RLD, RS |
| LEUPROLIDE ACETATE FOR DEPOT SUSPENSION | Cipla | N-205054 RX | 2018-08-28 | 1 products, RLD, RS |
| ELIGARD KIT | Tolmar | N-021343 RX | 2002-01-23 | 1 products, RLD, RS |
| ELIGARD KIT | Tolmar | N-021379 RX | 2002-07-24 | 1 products, RLD, RS |
| ELIGARD KIT | Tolmar | N-021488 RX | 2003-02-13 | 1 products, RLD, RS |
| ELIGARD KIT | Tolmar | N-021731 RX | 2004-12-14 | 1 products, RLD, RS |
Show 1 marketed
Show 4 discontinued
Leuprolide acetate
+
Norethindrone acetate
Leuprolide mesylate
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| CAMCEVI KIT | Accord Healthcare | N-211488 RX | 2021-05-25 | 1 products, RLD, RS |
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| camcevi | New Drug Application | 2024-07-15 |
| eligard | New Drug Application | 2024-05-28 |
| fensolvi | New Drug Application | 2024-10-17 |
| leuprolide acetate | ANDA | 2024-10-21 |
| leuprolide acetate depot | New Drug Application | 2024-08-27 |
| lupron | New Drug Application | 2013-10-30 |
| lupron depot | New Drug Application | 2024-03-12 |
| lupron depot-ped | New Drug Application | 2023-04-14 |
| lupron lupron | 2008-02-29 | |
| viadur | 2006-05-10 |
Indications
FDA
EMA
Show 3 more
Agency Specific
FDA
EMA
Expiration | Code | ||
|---|---|---|---|
LEUPROLIDE ACETATE, LUPRON DEPOT-PED KIT, ABBVIE ENDOCRINE INC | |||
| 2026-04-14 | NS | ||
LEUPROLIDE MESYLATE, CAMCEVI KIT, ACCORD | |||
| 2024-05-25 | NP | ||
LEUPROLIDE ACETATE, FENSOLVI KIT, TOLMAR | |||
| 2023-05-01 | I-829 | ||
Patent Expiration
Patent | Expires | Flag | FDA Information |
|---|---|---|---|
| Leuprolide Acetate, Eligard Kit, Tolmar | |||
| 11771841 | 2041-12-22 | DS, DP | |
| 8470359 | 2023-10-15 | DS, DP | U-621, U-2940 |
| Leuprolide Mesylate, Camcevi Kit, Accord | |||
| 11717555 | 2039-01-01 | DP | |
| 9572857 | 2027-01-16 | DP | |
| 9744207 | 2027-01-16 | DP | |
| 10646572 | 2027-01-16 | DP | |
| Leuprolide Acetate, Lupron Depot, Abbvie Endocrine Inc | |||
| 8921326 | 2031-02-05 | DP | U-1666 |
| Leuprolide Acetate, Lupron Depot-Ped Kit, Abbvie Endocrine Inc | |||
| 9617303 | 2028-03-22 | U-3611 | |
ATC Codes
HCPCS
Code | Description |
|---|---|
| J1950 | Injection, leuprolide acetate (for depot suspension), per 3.75 mg |
| J1951 | Injection, leuprolide acetate for depot suspension (fensolvi), 0.25 mg |
| J1952 | Leuprolide injectable, camcevi, 1 mg |
| J9217 | Leuprolide acetate (for depot suspension), 7.5 mg |
| J9218 | Leuprolide acetate, per 1 mg |
| J9219 | Leuprolide acetate implant, 65 mg |
| S9560 | Home injectable therapy; hormonal therapy (e.g.; leuprolide, goserelin), including administrative services, professional pharmacy services, care coordination, and all necessary supplies and equipment (drugs and nursing visits coded separately), per diem |
Clinical
Clinical Trials
476 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Prostatic neoplasms | D011471 | — | C61 | 27 | 121 | 69 | 13 | 31 | 246 |
| Breast neoplasms | D001943 | EFO_0003869 | C50 | 2 | 22 | 20 | 2 | 7 | 51 |
| Endometriosis | D004715 | EFO_0001065 | N80 | 1 | 8 | 5 | 4 | 7 | 25 |
| Precocious puberty | D011629 | — | E22.8 | 2 | — | 7 | 8 | 4 | 21 |
| Infertility | D007246 | HP_0000789 | — | 3 | — | 2 | 6 | 7 | 18 |
| Recurrence | D012008 | — | — | — | 5 | 6 | 1 | 1 | 13 |
| Leiomyoma | D007889 | HP_0000131 | D25 | 1 | 3 | 4 | 4 | 2 | 13 |
| Carcinoma | D002277 | — | C80.0 | 2 | 6 | 2 | 1 | 1 | 12 |
| Myofibroma | D047708 | — | — | 1 | 3 | 4 | 2 | 2 | 11 |
| Polycystic ovary syndrome | D011085 | EFO_0000660 | E28.2 | 1 | 1 | — | 3 | 3 | 8 |
Show 32 more
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Adenocarcinoma | D000230 | — | — | 3 | 22 | 7 | — | 3 | 33 |
| Neoplasms | D009369 | — | C80 | — | 6 | 4 | — | 1 | 11 |
| Obesity | D009765 | EFO_0001073 | E66.9 | 2 | — | 1 | — | 5 | 8 |
| Castration-resistant prostatic neoplasms | D064129 | — | — | 2 | 3 | 2 | — | — | 6 |
| Male breast neoplasms | D018567 | — | — | — | 1 | 3 | — | 1 | 5 |
| Female infertility | D007247 | EFO_0008560 | N97 | 1 | — | 1 | — | 2 | 4 |
| Alzheimer disease | D000544 | EFO_0000249 | F03 | — | 3 | 1 | — | — | 4 |
| Neoplasm metastasis | D009362 | EFO_0009708 | — | — | 1 | 1 | — | — | 2 |
| Cardiovascular diseases | D002318 | HP_0001626 | — | — | — | 1 | — | 1 | 2 |
| Pelvic pain | D017699 | — | — | — | 1 | 1 | — | — | 2 |
Show 23 more
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Hypersensitivity | D006967 | HP_0012393 | T78.40 | 2 | 6 | — | — | 1 | 9 |
| Hypogonadism | D007006 | HP_0000044 | E23.0 | — | 2 | — | — | 3 | 5 |
| Salivary gland neoplasms | D012468 | EFO_0003826 | D11 | — | 3 | — | — | 1 | 4 |
| Non-hodgkin lymphoma | D008228 | — | C85.9 | — | 3 | — | — | — | 3 |
| Multiple myeloma | D009101 | — | C90.0 | — | 3 | — | — | — | 3 |
| Healthy volunteers/patients | — | — | — | 3 | 1 | — | — | — | 3 |
| Primary ovarian insufficiency | D016649 | EFO_0004266 | E28.3 | — | 1 | — | — | 2 | 3 |
| Premature menopause | D008594 | HP_0008209 | E28.31 | — | 1 | — | — | 2 | 3 |
| Ovarian neoplasms | D010051 | EFO_0003893 | C56 | — | 3 | — | — | — | 3 |
| Hyperandrogenism | D017588 | — | — | 1 | 1 | — | — | — | 2 |
Show 45 more
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Overweight | D050177 | — | E66.3 | 1 | — | — | — | — | 1 |
| Antibiotic prophylaxis | D019072 | — | — | 1 | — | — | — | — | 1 |
| Transgenes | D019076 | — | — | 1 | — | — | — | — | 1 |
| Postmenopausal osteoporosis | D015663 | EFO_0003854 | — | 1 | — | — | — | — | 1 |
| Delayed puberty | D011628 | HP_0000823 | E30.0 | 1 | — | — | — | — | 1 |
| Menstruation disturbances | D008599 | HP_0400007 | N91.5 | 1 | — | — | — | — | 1 |
| Premenstrual syndrome | D011293 | — | N94.3 | 1 | — | — | — | — | 1 |
| Paraphilic disorders | D010262 | — | F65 | 1 | — | — | — | — | 1 |
| Postoperative pain | D010149 | — | G89.18 | 1 | — | — | — | — | 1 |
| Embryo transfer | D004624 | — | — | 1 | — | — | — | — | 1 |
Show 1 more
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Gender dysphoria | D000068116 | — | — | — | — | — | — | 2 | 2 |
| Endocrine system diseases | D004700 | EFO_0001379 | E34.9 | — | — | — | — | 1 | 1 |
| Adiposity | D050154 | — | — | — | — | — | — | 1 | 1 |
| Embryo implantation | D010064 | — | — | — | — | — | — | 1 | 1 |
| Executive function | D056344 | — | — | — | — | — | — | 1 | 1 |
| Coronary disease | D003327 | — | — | — | — | — | — | 1 | 1 |
| Coronary artery disease | D003324 | — | I25.1 | — | — | — | — | 1 | 1 |
| Myocardial ischemia | D017202 | EFO_1001375 | I20-I25 | — | — | — | — | 1 | 1 |
| Heart diseases | D006331 | EFO_0003777 | I51.9 | — | — | — | — | 1 | 1 |
| Microbiota | D064307 | — | — | — | — | — | — | 1 | 1 |
Show 12 more
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Leuprolide |
| INN | leuprorelin |
| Description | Leuprolide is an oligopeptide comprising pyroglutamyl, histidyl, tryptophyl, seryl, tyrosyl, D-leucyl, leucyl, arginyl, and N-ethylprolinamide residues joined in sequence. It is a synthetic nonapeptide analogue of gonadotropin-releasing hormone, and is used as a subcutaneous hydrogel implant (particularly as the acetate salt) for the treatment of prostate cancer and for the suppression of gonadal sex hormone production in children with central precocious puberty. It has a role as an antineoplastic agent, a gonadotropin releasing hormone agonist and an anti-estrogen. |
| Classification | Peptide |
| Drug class | GnRH analogue; GnRH agonist; Antigonadotropin |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | CCNC(=O)[C@@H]1CCCN1C(=O)[C@H](CCCNC(=N)N)NC(=O)[C@H](CC(C)C)NC(=O)[C@@H](CC(C)C)NC(=O)[C@H](Cc1ccc(O)cc1)NC(=O)[C@H](CO)NC(=O)[C@H](Cc1c[nH]c2ccccc12)NC(=O)[C@H](Cc1c[nH]cn1)NC(=O)[C@@H]1CCC(=O)N1 |
Identifiers
| PDB | — |
| CAS-ID | 53714-56-0 |
| RxCUI | — |
| ChEMBL ID | CHEMBL1201199 |
| ChEBI ID | 6427 |
| PubChem CID | 657181 |
| DrugBank | DB00007 |
| UNII ID | EFY6W0M8TG (ChemIDplus, GSRS) |
Target
Agency Approved
GNRHR
GNRHR
Organism
Homo sapiens
Gene name
GNRHR
Gene synonyms
GRHR
NCBI Gene ID
Protein name
gonadotropin-releasing hormone receptor
Protein synonyms
gnRH receptor, gnRH-R, gonadotropin-releasing hormone (type 1) receptor 1, leutinizing hormone releasing horomone receptor, leutinizing-releasing hormone receptor, luliberin receptor, type I GnRH receptor
Uniprot ID
Mouse ortholog
Gnrhr (14715)
gonadotropin-releasing hormone receptor (Q61611)
Alternate
No data
Variants
No data
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Lupron – AbbVie
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Leuprolide
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Trends
PubMed Central
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Safety
Black-box Warning
No Black-box warning
Adverse Events
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72,165 adverse events reported
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