Leuprolide acetate
Highest phase reached
Approved
Drug type
Protein
First approval year
1985
- First approval year
- 1985
- Listing at source
- Listed
- Highest phase reached
- Approved
- Drug type
- Protein
- Drug name
- Leuprolide acetate
- Molecular weight
- 1,269.47
- Structure (SMILES)
- CC(=O)O.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
- eligard
- Eligard
- eligard kit
- Eligard kit
- fensolvi kit
- Fensolvi kit
- leuprolide acetate
- Leuprolide acetate
- lupron
- Lupron
- lupron depot
- Lupron depot
- lupron depot ped
- Lupron depot ped
- lupron depot ped kit
- Lupron depot-ped
- Lupron depot-ped kit
- lutrate depot kit
- Lutrate depot kit
- viadur
- Viadur
- a 43818
- A-43818
- abbott 43818
- ABBOTT-43818
- carcinil
- Carcinil
- casodex zoladex lupron
- Eligard
- ELIGARD
- ELIGARD 22.5mg
- Eligard 22.5Mg Suspension for Injection
- Eligard® 45 mg
- enantone
- Enantone
- Enantone (Leuprorelin Acetate Microspheres for Injection)
- fensolvi
- Fensolvi
- GnRH Agonist (Lupron Depot)
- leuplin
- Leuplin
- leuporelin acetate
- Leuporelin acetate
- leuprolide acetate
- Leuprolide acetate
- Leuprolide acetate ( ELIGARD®) Hormonal Therapy
And 39 more, listed on the interactive page.
- CAS registry numbers
- 74381-53-6
- ChEMBL ID
- CHEMBL1200775
- InChIKey
- RGLRXNKKBLIBQS-XNHQSDQCSA-N
- PubChem compound IDs
- 657180
- RxNorm IDs (RxCUI)
- 203217
- FDA ingredient codes (UNII)
- 37JNS02E7V
- Applicant
- TOLMAR
- Approval date
- 23 Jan 2002
- Application number
- NDA021343
- Patents
- 19
- Designations
- 2
- Earliest recorded loss of exclusivity
- 22 Dec 2041
- First in class
- No
- Fast track
- No
- Breakthrough designation
- No
- Orphan designation
- No
- Priority review
- Yes
- Orphan exclusivity
- No
- Accelerated approval
- No
- Availability
- Prescription only
- Pharmacology name
- leuprolide
- Type
- Peptide
Administration routes
- Oral
- Parenteral
Mechanisms of action
- Mechanism
- Gonadotropin-releasing hormone receptor agonist
- Action type
- Agonist
- Target
- Gonadotropin-releasing hormone receptor
- Protein identifier
- P30968
Open Targets mechanisms
- Mechanism
- Gonadotropin-releasing hormone receptor agonist
- Action type
- Agonist
- Target
- Gonadotropin-releasing hormone receptor
- Condition
- Hodgkin Disease
- Highest recorded phase
- 2
- Condition identifier
- EFO:0000183
- Subject identifier
- D006689
- Condition
- Prostatic Neoplasms
- Highest recorded phase
- 4
- Condition identifier
- EFO:0000196
- Subject identifier
- D011471
- Condition
- Hypertension
- Highest recorded phase
- 0.5
- Condition identifier
- EFO:0000537
- Subject identifier
- D006973
- Condition
- Prostatic Neoplasms
- Highest recorded phase
- 4
- Condition identifier
- EFO:0000673
- Subject identifier
- D011471
- Condition
- Leiomyoma
- Highest recorded phase
- 3
- Condition identifier
- EFO:0000731
- Subject identifier
- D007889
- Condition
- Endometriosis
- Highest recorded phase
- 3
- Condition identifier
- EFO:0001065
- Subject identifier
- D004715
- Condition
- Obesity
- Highest recorded phase
- 3
- Condition identifier
- EFO:0001073
- Subject identifier
- D009765
- Condition
- Multiple Myeloma
- Highest recorded phase
- 2
- Condition identifier
- EFO:0001378
- Subject identifier
- D009101
- Condition
- Prostatic Neoplasms
- Highest recorded phase
- 4
- Condition identifier
- EFO:0001663
- Subject identifier
- D011471
- Condition
- Breast Neoplasms
- Highest recorded phase
- 3
- Condition identifier
- EFO:0003869
- Subject identifier
- D001943
- Condition
- Infertility, Male
- Highest recorded phase
- 3
- Condition identifier
- EFO:0004248
- Subject identifier
- D007248
- Condition
- Bulimia Nervosa
- Highest recorded phase
- 2
- Condition identifier
- EFO:0005204
- Subject identifier
- D052018
- Condition
- Depression, Postpartum
- Highest recorded phase
- 2
- Condition identifier
- EFO:0007453
- Subject identifier
- D019052
- Condition
- Puberty, Precocious
- Highest recorded phase
- 4
- Condition identifier
- EFO:0009029
- Subject identifier
- D011629
- Condition
- Salivary Gland Neoplasms
- Highest recorded phase
- 2
- Condition identifier
- EFO:1000384
- Subject identifier
- D012468
- Condition
- Lymphoma, Mantle-Cell
- Highest recorded phase
- 2
- Condition identifier
- EFO:1001469
- Subject identifier
- D020522
- Condition
- Cognitive Dysfunction
- Highest recorded phase
- 2
- Condition identifier
- HP:0100543
- Subject identifier
- D060825
- Condition
- Puberty, Precocious
- Highest recorded phase
- 4
- Condition identifier
- MONDO:0000088
- Subject identifier
- D011629
- Condition
- Salivary Gland Neoplasms
- Highest recorded phase
- 2
- Condition identifier
- MONDO:0000521
- Subject identifier
- D012468
- Condition
- Depressive Disorder
- Highest recorded phase
- 2
- Condition identifier
- MONDO:0002050
- Subject identifier
- D003866
- Condition
- Alzheimer Disease
- Highest recorded phase
- 2
- Condition identifier
- MONDO:0004975
- Subject identifier
- D000544
- Condition
- Neoplasms
- Highest recorded phase
- 3
- Condition identifier
- MONDO:0004992
- Subject identifier
- D009369
- Condition
- Breast Neoplasms
- Highest recorded phase
- 3
- Condition identifier
- MONDO:0007254
- Subject identifier
- D001943
- Condition
- Prostatic Neoplasms
- Highest recorded phase
- 4
- Condition identifier
- MONDO:0008315
- Subject identifier
- D011471
- Condition
- Granulosa Cell Tumor
- Highest recorded phase
- 2
- Condition identifier
- MONDO:0020541
- Subject identifier
- D006106
- Condition identifier
- EFO_0000196
- Highest recorded phase
- 2
- Condition identifier
- EFO_0000537
- Condition identifier
- EFO_0000673
- Highest recorded phase
- 3
- Condition identifier
- EFO_0000731
- Highest recorded phase
- 3
- Condition identifier
- EFO_0001065
- Highest recorded phase
- 3
- Condition identifier
- EFO_0001073
- Highest recorded phase
- 3
- Condition identifier
- EFO_0001663
- Condition identifier
- EFO_0003869
- Highest recorded phase
- 2
- Condition identifier
- EFO_0005204
- Highest recorded phase
- 2
- Condition identifier
- EFO_0006461
- Highest recorded phase
- 2
- Condition identifier
- EFO_0007453
- Highest recorded phase
- 2
- Condition identifier
- EFO_0008008
- Condition identifier
- EFO_0009029
- Highest recorded phase
- 3
- Condition identifier
- EFO_0011050
- Highest recorded phase
- 2
- Condition identifier
- EFO_1000384
- Highest recorded phase
- 2
- Condition identifier
- HP_0000131
- Highest recorded phase
- 3
- Condition identifier
- HP_0000132
- Highest recorded phase
- 3
- Condition identifier
- HP_0000789
- Condition identifier
- HP_0000823
- Highest recorded phase
- 1
- Condition identifier
- HP_0000855
- Highest recorded phase
- 2
- Condition identifier
- HP_0100543
- Highest recorded phase
- 2
- Condition identifier
- MONDO_0000088
- Condition identifier
- MONDO_0000088
- Highest recorded phase
- 4
- Condition identifier
- MONDO_0000521
- Highest recorded phase
- 2
- Condition identifier
- MONDO_0002050
- Highest recorded phase
- 2
And 33 more, listed on the interactive page.
- Event
- abscess sterile
- Reports
- 49
- Reporting signal score
- 211.27
- Event
- blood testosterone abnormal
- Reports
- 151
- Reporting signal score
- 633.411
- Event
- blood testosterone increased
- Reports
- 183
- Reporting signal score
- 671.09
- Event
- diarrhoea
- Reports
- 126
- Reporting signal score
- 195.52
- Event
- drug hypersensitivity
- Reports
- 17
- Reporting signal score
- 176.88
- Event
- endometriosis
- Reports
- 195
- Reporting signal score
- 592.334
- Event
- hot flush
- Reports
- 1,124
- Reporting signal score
- 2,490.02
- Event
- injection site abscess
- Reports
- 114
- Reporting signal score
- 297.816
- Event
- injury associated with device
- Reports
- 113
- Reporting signal score
- 181.269
- Event
- intercepted product administration error
- Reports
- 79
- Reporting signal score
- 294.084
- Event
- intercepted product preparation error
- Reports
- 1,982
- Reporting signal score
- 8,820.59
- Event
- malignant neoplasm progression
- Reports
- 481
- Reporting signal score
- 489.515
- Event
- menorrhagia
- Reports
- 147
- Reporting signal score
- 173.152
- Event
- metastases to bone
- Reports
- 289
- Reporting signal score
- 570.14
- Event
- needle issue
- Reports
- 286
- Reporting signal score
- 534.983
- Event
- occupational exposure to product
- Reports
- 111
- Reporting signal score
- 205.173
- Event
- pelvic pain
- Reports
- 193
- Reporting signal score
- 324.124
- Event
- product leakage
- Reports
- 270
- Reporting signal score
- 975.558
- Event
- prostate cancer
- Reports
- 245
- Reporting signal score
- 415.149
- Event
- prostate cancer metastatic
- Reports
- 118
- Reporting signal score
- 351.387
- Event
- prostatic specific antigen abnormal
- Reports
- 58
- Reporting signal score
- 215.941
- Event
- prostatic specific antigen increased
- Reports
- 513
- Reporting signal score
- 1,513.37
- Event
- syringe issue
- Reports
- 2,363
- Reporting signal score
- 9,894
- Event
- uterine leiomyoma
- Reports
- 106
- Reporting signal score
- 199.13
- Event
- vaginal haemorrhage
- Reports
- 210
- Reporting signal score
- 224.763
And 1 more, listed on the interactive page.
- NCT00002580
- NCT00002582
- NCT00498901
- NCT01546649
- NCT01674140
- NCT02592746
- NCT03664895
- NCT03900637
- NCT04711252
- NCT04964934
- NCT00003517
- NCT00075192
- NCT00170157
- NCT00512668
- NCT00544830
- NCT00589472
- NCT00937768
- NCT01023061
- NCT01120236
- NCT01122121
- NCT01163084
- NCT01431391
- NCT01786265
- NCT02023463
- NCT02058706
And 55 more, listed on the interactive page.
- Dose
- 1 mg
- Route
- Subcutaneous
- How often
- Once daily
- Inspect solution before use
- Vary injection site periodically
- Prodrug
- No
- Chirality
- Single enantiomer
- Inorganic
- No
- Heavy atoms
- 91
- Molecular formula
- C61H88N16O14
- Monoisotopic mass
- 1268.66659154
- Natural product
- No
- 42023-259
- 62935-163
- 62935-227
- 62935-306
- 62935-461
- 62935-756
- 85043-025
- 85043-030
- 85043-045
- 85043-075
- Recorded assays
- 205
- Active assays
- 0
- Fertility Agents, Female
- Antineoplastic Agents, Hormonal
Related records
Trials (321)
- A Clinical Study Evaluating The Benefit of Adding Rucaparib to Enzalutamide for Men With Metastatic Prostate Cancer That Has Become Resistant To Testosterone-Deprivation Therapy
- A Clinical Study of KLH-2109 in Patients With Endometriosis
- A Clinical Study of KLH-2109 in Uterine Fibroids Patient With Menorrhagia
- A GnRH Agonist IN Pre-menopausal Women STudy to Treat Severe Polycystic Liver Disease
- A Long-term Extension Study Evaluating a One-Month Dosing Regimen of Degarelix in Prostate Cancer Requiring Androgen Ablation Therapy
- A Long-term Extension Study of TAK-385 in the Treatment of Endometriosis
- A Multi-Center Trial of Androgen Suppression With Abiraterone Acetate, Leuprolide, PARP Inhibition and Stereotactic Body Radiotherapy in Prostate Cancer
- A Multicenter Open-label Clinical Study on the Prevention of Premature Ovarian Failure After HSCT
- A Novel Approach to Endometrial Preparation in Recipients of Donor Eggs
- A Pharmacodynamic Study of Leuprorelin Gelatin-Free Formulation in Female Subjects With Uterine Fibroids.
- A Phase 2 Study to Evaluate Safety and Efficacy of Abiraterone Acetate in Male Participants With Prostate Cancer
- A Phase 2 Study to Evaluate the Safety and Efficacy of TAK-385, Together With a Leuprorelin Observational Cohort, in Participants With Prostate Cancer
- A Phase 3 Comparative Study of TAP-144-SR(6M) in Postoperative and Hormone Therapy-naïve Patients With Premenopausal Breast Cancer
- A Phase 3 Comparative Study of TAP-144-SR(6M) in Prostate Cancer Patients Previously Treated With Hormonal Therapy
- A Phase 3 Study to Evaluate the Efficacy and Safety of Relugolix (TAK-385) 40 mg Compared With Leuprorelin in the Treatment of Uterine Fibroids
- A Phase Ia Trial Comparing the Pharmacokinetics/Pharmacodynamics, Safety, and Preliminary Efficacy of HHK001 and Enantone in Patients With Endometriosis
- A Phase II Study of Advanced Salivary Gland Carcinoma Based on Molecular Typing
- A Phase II Study of Androgen Deprivation Therapy With or Without Palbociclib in RB-Positive Metastatic Prostate Cancer
- A Phase IIIb Study of Intermittent Versus Continuous Hormone Deprivation Treatment With ELIGARD
- A Pilot Study of 5-AZA and ATRA for Prostate Cancer With PSA-only Recurrence After Local Treatment
Approved for (6)
- Central precocious puberty
- Metastatic prostate carcinoma
- Precocious puberty
- Prostate adenocarcinoma
- Prostate cancer
- Prostate carcinoma
In development for (18)
- Alzheimer disease Phase 2
- Breast cancer Phase 3
- Breast neoplasm Phase 3
- Bulimia nervosa Phase 2
- Cancer Phase 3
- Depressive disorder Phase 2
- Endometriosis Phase 3
- Hodgkins lymphoma Phase 2
- Hypertensive disorder Early phase 1
- Male infertility Phase 3
- Maligant granulosa cell tumor of ovary Phase 2
- Mantle cell lymphoma Phase 2
- Obesity disorder Phase 3
- Plasma cell myeloma Phase 2
- Postpartum depression Phase 2
- Salivary gland carcinoma Phase 2
- Tumor of salivary gland Phase 2
- Uterine corpus leiomyoma Phase 3
Other linked conditions (3)
- Bulbospinal muscular atrophy
- Kennedy disease
- Prostate neoplasm
Targets (1)
- GNRHR Gonadotropin-releasing hormone receptor agonist