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Leuprolide
Camcevi, Depot, Eligard, Fensolvi, Lupaneta Pack, Lupron, Lupron Depot (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
Therapeutic Area
MeSH
neoplasmsD009369
urogenital diseasesD000091642
skin and connective tissue diseasesD017437
endocrine system diseasesD004700
Trade Name
FDA
EMA
Camcevi, Eligard, Fensolvi, Lupron depot, Lupron depot-ped, Lutrate depot (generic drugs available since 1998-08-04, discontinued: Lupron, 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 DEPOTAbbVieN-019732 RX1989-01-26
1 products, RLD, RS
LUPRON DEPOTAbbVieN-020011 RX1995-10-26
1 products, RLD, RS
LUPRON DEPOT-PED KITAbbVieN-020263 RX1993-04-16
6 products, RLD, RS
LUPRON DEPOTAbbVieN-020517 RX1995-12-22
3 products, RLD
LUPRON DEPOTAbbVieN-020708 RX1997-03-07
1 products, RLD, RS
LUTRATE DEPOT KITCiplaN-205054 RX2018-08-28
1 products, RLD, RS
ELIGARD KITTolmarN-021343 RX2002-01-23
1 products, RLD, RS
ELIGARD KITTolmarN-021379 RX2002-07-24
1 products, RLD, RS
ELIGARD KITTolmarN-021488 RX2003-02-13
1 products, RLD, RS
ELIGARD KITTolmarN-021731 RX2004-12-14
1 products, RLD, RS
Show 1 marketed
Show 4 discontinued
Leuprolide acetate
+
Norethindrone acetate
Tradename
Company
Number
Date
Products
LUPANETA PACKAbbVieN-203696 DISCN2012-12-14
2 products, RLD
Hide discontinued
Leuprolide mesylate
Tradename
Company
Number
Date
Products
CAMCEVI KITAccord HealthcareN-211488 RX2021-05-25
1 products, RLD, RS
Labels
FDA
EMA
Brand Name
Status
Last Update
camceviNew Drug Application2023-04-03
eligardNew Drug Application2023-01-09
fensolviNew Drug Application2023-02-28
lupron depotNew Drug Application2023-01-21
viadur2006-05-10
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
breast neoplasmsEFO_0003869D001943C50
endometrial neoplasmsEFO_0004230D016889—
endometriosisEFO_0001065D004715N80
infertilityEFO_0000545D007246—
leiomyomaHP_0000131D007889D25
ovarian neoplasmsEFO_0003893D010051C56
precocious puberty—D011629E22.8
prostatic hyperplasiaEFO_0000284D011470N40
prostatic neoplasms—D011471C61
Agency Specific
FDA
EMA
Expiration
Code
LEUPROLIDE ACETATE, LUPRON DEPOT-PED KIT, ABBVIE ENDOCRINE INC
2026-04-14NS
LEUPROLIDE MESYLATE, CAMCEVI KIT, ACCORD
2024-05-25NP
LEUPROLIDE ACETATE, FENSOLVI KIT, TOLMAR
2023-05-01I-829
Patent Expiration
Patent
Expires
Flag
FDA Information
Leuprolide Acetate, Lupron Depot, Abbvie Endocrine Inc
89213262031-02-05DPU-1666
Leuprolide Acetate, Lupron Depot-Ped Kit, Abbvie Endocrine Inc
96173032028-03-22U-3611
Leuprolide Mesylate, Camcevi Kit, Accord
95728572027-01-16DP
97442072027-01-16DP
106465722027-01-16DP
Leuprolide Acetate, Eligard Kit, Tolmar
84703592023-10-15DS, DPU-621, U-2940
ATC Codes
L: Antineoplastic and immunomodulating agents
— L02: Endocrine therapy antineoplastic and immunomodulating agents
— L02A: Hormones and related agents
— L02AE: Gonadotropin releasing hormone analogues, endocrine therapy drugs
— L02AE02: Leuprorelin
— L02AE51: Leuprorelin and bicalutamide
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
22 clinical trials
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Indications Phases 4
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
GoutD006073EFO_0004274M103161112
Chronic renal insufficiencyD051436N18———1—1
Indications Phases 3
No data
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
HyperuricemiaD033461—1——12
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Healthy volunteers/patients—8————8
Indications Without Phase
No data
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameLEUPROLIDE
INNleuprorelin
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
Protein
Drug classGnRH 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-ID53714-56-0
RxCUI42375
ChEMBL IDCHEMBL1201199
ChEBI ID6427
PubChem CID657181
DrugBankDB00007
UNII IDEFY6W0M8TG (ChemIDplus, GSRS)
Target
Agency Approved
GNRHR
GNRHR
Organism
Homo sapiens
Gene name
GNRHR
Gene synonyms
GRHR
NCBI Gene ID
2798
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
Q92644
Mouse ortholog
Gnrhr (14715)
gonadotropin-releasing hormone receptor (Q61611)
Alternate
No data
Variants
Clinical Variant
No data
Financial
Lupron - AbbVie
$
€
£
₣
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Tabular view
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 7,807 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
Mock data
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83 adverse events reported
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