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Drug ReportsLeuprorelin
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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Drug
Target
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Financial
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Events Timeline
5D
1M
3M
6M
YTD
1Y
2Y
5Y
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FDA approval date
EMA approval date
Patent expiration date
Study first post date
Last update post date
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Results first post date
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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
No data
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
No data
Labels
FDA
EMA
Brand Name
Status
Last Update
camceviNew Drug Application2024-07-15
eligardNew Drug Application2024-05-28
fensolviNew Drug Application2024-10-17
leuprolide acetateANDA2025-01-08
leuprolide acetate depotNew Drug Application2024-08-27
lupronNew Drug Application2013-10-30
lupron depotNew Drug Application2024-03-12
lupron depot-pedNew Drug Application2023-04-14
lupron lupron2008-02-29
viadur2006-05-10
Indications
FDA
EMA
No data
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, Eligard Kit, Tolmar
117718412041-12-22DS, DP
84703592023-10-15DS, DPU-621, U-2940
Leuprolide Mesylate, Camcevi Kit, Accord
117175552039-01-01DP
95728572027-01-16DP
97442072027-01-16DP
106465722027-01-16DP
Leuprolide Acetate, Lupron Depot, Abbvie Endocrine Inc
89213262031-02-05DPU-1666
Leuprolide Acetate, Lupron Depot-Ped Kit, Abbvie Endocrine Inc
96173032028-03-22U-3611
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
477 clinical trials
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Indications Phases 4
No data
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Precocious pubertyD011629—E22.8——1——1
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
EndometriosisD004715EFO_0001065N8011———2
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
InfertilityD007246HP_0000789—1————1
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Prostatic neoplasmsD011471—C61————11
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)Loading
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
RxCUI—
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
No data
Financial
Revenue by drug
$
€
£
₣
Lupron – AbbVie
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Tabular view
Estimated US medical usage
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 9,267 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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79,242 adverse events reported
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