Leuprolide
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
- Molecular weight
- 1,209.42
- Structure (SMILES)
- 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
- (-)-leuprolide
- 1 9 luteinizing hormone releasing factor swine 6 d leucine 9 n ethyl l prolinamide
- 1-9-Luteinizing hormone-releasing factor (swine), 6-D-leucine-9-(N-ethyl-L-prolinamide)-
- 5 oxo l prolyl l histidyl l tryptophyl l seryl l tyrosyl d leucyl l leucyl l arginyl n ethyl lprolinamide
- 5-Oxo-L-prolyl-L-histidyl-L-tryptophyl-L-seryl-L-tyrosyl-D-leucyl-L-leucyl-L-arginyl-N-ethyl-Lprolinamide
- abbott 43818 free base
- ABBOTT-43818 FREE BASE
- ckd 841
- ckd 841 a 1 1 88mg
- ckd 841 a 1 3 75mg
- CKD-841
- CKD-841 A-1 1.88mg
- CKD-841 A-1 3.75mg
- fp 001
- FP-001
- leuporelin
- Leuporelin
- leuprolide
- Leuprolide
- LEUPROLIDE [HSDB]
- LEUPROLIDE [MI]
- LEUPROLIDE [USAN]
- LEUPROLIDE [VANDF]
- leuprolide hsdb
- leuprolide mi
And 24 more, listed on the interactive page.
- ATC classification codes
- L02AE02
Sources for recorded values
- CAS registry numbers
- 53714-56-0
- ChEMBL ID
- CHEMBL1201199
- InChIKey
- GFIJNRVAKGFPGQ-LIJARHBVSA-N
- PubChem compound IDs
- 657181
- FDA ingredient codes (UNII)
- EFY6W0M8TG
- 42375
- 203217
- Applicant
- ABBVIE ENDOCRINE INC
- Approval date
- 9 Apr 1985
- Application number
- NDA019010
- First in class
- No
- Orphan designation
- No
- Availability
- Prescription only
- United States (FDA)
- Approved
- Pharmacology name
- leuprolide
- Type
- Peptide
- Approval recorded by Guide to Pharmacology
- Yes
Administration routes
- Oral
- Parenteral
Mechanisms of action
- Action
- Full agonist
- Action type
- FULL_AGONIST
- Target
- GnRH1 receptor
- Gene symbol
- GNRHR
- Protein identifier
- P30968
- Affinity units
- pKi
- Primary target
- Yes
Open Targets mechanisms
- Mechanism
- Gonadotropin-releasing hormone receptor agonist
- Action type
- Agonist
- Target
- Gonadotropin-releasing hormone receptor
DrugCentral mechanisms
- Action type
- Agonist
- Gene symbol
- GNRHR
- Protein identifier
- P30968
- Organism
- Homo sapiens
- Target development level
- Clinical
- Condition
- Prostatic Neoplasms
- Highest recorded phase
- 3
- Condition identifier
- EFO:0000196
- Subject identifier
- D011471
- Condition
- Breast Neoplasms
- Highest recorded phase
- 3
- Condition identifier
- EFO:0000305
- Subject identifier
- D001943
- Condition
- Infertility
- Highest recorded phase
- 3
- Condition identifier
- EFO:0000545
- Subject identifier
- D007246
- Condition
- Neoplasms
- Highest recorded phase
- 4
- Condition identifier
- EFO:0000616
- Subject identifier
- D009369
- Condition
- Prostatic Neoplasms
- Highest recorded phase
- 3
- Condition identifier
- EFO:0000673
- Subject identifier
- D011471
- Condition
- Leiomyoma
- Highest recorded phase
- 3
- Condition identifier
- EFO:0000731
- Subject identifier
- D007889
- Condition
- Melanoma
- Highest recorded phase
- 2
- Condition identifier
- EFO:0000756
- Subject identifier
- D008545
- Condition
- HIV Infections
- Highest recorded phase
- 1
- Condition identifier
- EFO:0000764
- Subject identifier
- D015658
- Condition
- Endometriosis
- Highest recorded phase
- 3
- Condition identifier
- EFO:0001065
- Subject identifier
- D004715
- Condition
- Obesity
- Highest recorded phase
- 1
- Condition identifier
- EFO:0001073
- Subject identifier
- D009765
- Condition
- Prostatic Neoplasms
- Highest recorded phase
- 3
- Condition identifier
- EFO:0001663
- Subject identifier
- D011471
- Condition
- Pain
- Highest recorded phase
- 3
- Condition identifier
- EFO:0003843
- Subject identifier
- D010146
- Condition
- Hyperandrogenism
- Highest recorded phase
- 2
- Condition identifier
- EFO:0009006
- Subject identifier
- D017588
- Condition
- Menopause
- Highest recorded phase
- 1
- Condition identifier
- GO:0042697
- Subject identifier
- D008593
- Condition
- Salivary Gland Neoplasms
- Highest recorded phase
- 2
- Condition identifier
- MONDO:0000521
- Subject identifier
- D012468
- Condition
- Leiomyoma
- Highest recorded phase
- 3
- Condition identifier
- MONDO:0001572
- Subject identifier
- D007889
- Condition
- Hypogonadism
- Highest recorded phase
- 2
- Condition identifier
- MONDO:0002146
- Subject identifier
- D007006
- Condition
- Liver Neoplasms
- Highest recorded phase
- 2
- Condition identifier
- MONDO:0002691
- Subject identifier
- D008113
- Condition
- Myoma
- Highest recorded phase
- 3
- Condition identifier
- MONDO:0003061
- Subject identifier
- D009214
- Condition
- Breast Neoplasms
- Highest recorded phase
- 3
- Condition identifier
- MONDO:0007254
- Subject identifier
- D001943
- Condition
- Prostatic Neoplasms, Castration-Resistant
- Highest recorded phase
- 3
- Condition identifier
- MONDO:0008315
- Subject identifier
- D064129
- Condition identifier
- EFO_0000196
- Highest recorded phase
- 2
- Condition identifier
- EFO_0000305
- Highest recorded phase
- 2
- Condition identifier
- EFO_0000545
- Highest recorded phase
- 3
- Condition identifier
- EFO_0000616
- Condition identifier
- EFO_0000673
- Highest recorded phase
- 3
- Condition identifier
- EFO_0000731
- Highest recorded phase
- 3
- Condition identifier
- EFO_0001065
- Highest recorded phase
- 2
- Condition identifier
- EFO_0001663
- Highest recorded phase
- 3
- Condition identifier
- EFO_0009006
- Highest recorded phase
- 1
- Condition identifier
- EFO_0009006
- Highest recorded phase
- 2
- Condition identifier
- EFO_0009008
- Highest recorded phase
- 2
- Condition identifier
- EFO_0009029
- Highest recorded phase
- 3
- Condition identifier
- EFO_1001491
- Condition identifier
- GO_0042697
- Highest recorded phase
- 1
- Condition identifier
- HP_0000789
- Condition identifier
- HP_0000855
- Highest recorded phase
- 2
- Condition identifier
- HP_0004322
- Highest recorded phase
- 3
- Condition identifier
- MONDO_0000088
- Highest recorded phase
- 3
- Condition identifier
- MONDO_0000447
- Highest recorded phase
- 2
- Condition identifier
- MONDO_0000521
- Highest recorded phase
- 2
- Condition identifier
- MONDO_0002146
- Condition identifier
- MONDO_0004669
- Condition identifier
- MONDO_0004956
- Highest recorded phase
- 2
- Condition identifier
- MONDO_0004967
- Highest recorded phase
- 2
- Condition identifier
- MONDO_0004992
- Highest recorded phase
- 2
And 21 more, listed on the interactive page.
- Event
- acute coronary syndrome
- Reports
- 9
- Reporting signal score
- 18.462
- Event
- acute myocardial infarction
- Reports
- 9
- Reporting signal score
- 10.2994
- Event
- adenocarcinoma
- Reports
- 4
- Reporting signal score
- 11.2056
- Event
- adrenocortical insufficiency acute
- Reports
- 8
- Reporting signal score
- 30.4953
- Event
- anaplastic meningioma
- Reports
- 2
- Reporting signal score
- 13.7336
- Event
- blood electrolytes abnormal
- Reports
- 14
- Reporting signal score
- 65.8558
- Event
- blood testosterone abnormal
- Reports
- 3
- Reporting signal score
- 11.1189
- Event
- blood testosterone decreased
- Reports
- 5
- Reporting signal score
- 12.7497
- Event
- blood urea abnormal
- Reports
- 14
- Reporting signal score
- 70.8539
- Event
- bone lesion
- Reports
- 4
- Reporting signal score
- 9.4695
- Event
- cardiac ventricular scarring
- Reports
- 2
- Reporting signal score
- 14.8525
- Event
- cerebrospinal fluid leakage
- Reports
- 3
- Reporting signal score
- 8.71242
- Event
- child abuse
- Reports
- 3
- Reporting signal score
- 17.1701
- Event
- chronic kidney disease
- Reports
- 7
- Reporting signal score
- 8.66494
- Event
- coccydynia
- Reports
- 4
- Reporting signal score
- 14.7155
- Event
- diffuse large b-cell lymphoma recurrent
- Reports
- 4
- Reporting signal score
- 11.8898
- Event
- disease progression
- Reports
- 26
- Reporting signal score
- 29.5511
- Event
- drug dependence
- Reports
- 9
- Reporting signal score
- 11.4445
- Event
- electrocardiogram qt prolonged
- Reports
- 13
- Reporting signal score
- 14.5045
- Event
- endometrial stromal sarcoma
- Reports
- 4
- Reporting signal score
- 26.2533
- Event
- enterobacter infection
- Reports
- 4
- Reporting signal score
- 13.0177
- Event
- epidural lipomatosis
- Reports
- 3
- Reporting signal score
- 12.7416
- Event
- epiphysiolysis
- Reports
- 3
- Reporting signal score
- 12.9771
- Event
- erectile dysfunction
- Reports
- 8
- Reporting signal score
- 12.5305
- Event
- fracture
- Reports
- 7
- Reporting signal score
- 10.1466
And 40 more, listed on the interactive page.
- NCT00004054
- NCT00005044
- NCT00006359
- NCT00016913
- NCT00028769
- NCT00288080
- NCT00295750
- NCT00329043
- NCT00388804
- NCT00430183
- NCT00451958
- NCT00500110
- NCT00528866
- NCT00567580
- NCT00587431
- NCT00631527
- NCT00924469
- NCT00928434
- NCT00936390
- NCT01377389
- NCT01547299
- NCT01674270
- NCT01750398
- NCT02083185
- NCT02085252
And 63 more, listed on the interactive page.
- Dose
- 1mg
- Route
- Subcutaneous
- How often
- Once daily
Conditions of use
- Varied injection site periodically
- Calculated partition coefficient (XLogP)
- 0.7
- Prodrug
- No
- Chirality
- Single enantiomer
- Inorganic
- No
- Heavy atoms
- 87
- Molecular formula
- C59H84N16O12
- Monoisotopic mass
- 1208.64546218
- Natural product
- No
- Recorded assays
- 200
- Active assays
- 13
- Confirmatory
- Other
- Fertility Agents, Female
- Antineoplastic Agents, Hormonal
Related records
Trials (120)
- 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 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 Study to Evaluate the Efficacy and Safety of Relugolix (TAK-385) 40 mg Compared With Leuprorelin in the Treatment of Uterine Fibroids
- A Phase II Study of Advanced Salivary Gland Carcinoma Based on Molecular Typing
- A Short-term Preoperative, Evaluating Activity and Safety of Elacestrant Monotherapy as Compared to Elacestrant + Ovarian Function Suppression (LHRH Agonist) in Premenopausal Patients With Stage I-II ER+/HER2- Breast Cancer
- A Study of Androgen Deprivation With Leuprolide, +/- Docetaxel for Clinically Asymptomatic Prostate Cancer Participants With a Rising Prostate Specific Antigen (PSA)
- A Study of Degarelix in Patients With Prostate Cancer
- A Study of ELIGARD® in Hormone-dependent Prostate Cancer Patients
- A Study of Leuprorelin 1-Month (4-Week) Formulation in Children With Central Precocious Puberty
- A Study of Pharmacokinetic/Pharmacodynamic Profile of Orally Administered Leuprolide in Healthy Female Volunteers
- A Study of Progenta (CDB-4124) in Pre-menopausal Women With Symptomatic Leiomyomata
- A Study of the Effect of Enantone LP 11.25 mg (Leuprorelin) on the Histological Progression of Indolent Prostate Cancer
- A Study to Assess the Safety and Efficacy of Leuprorelin in Central Precocious Puberty in Chinese Participants
- A Treatment Study for Premenstrual Syndrome (PMS)
Approved for (2)
- Neoplasm
- Prostate neoplasm
In development for (26)
- Acute lymphoblastic leukemia Phase 2
- Acute myeloid leukemia Phase 2
- Autosomal dominant polycystic liver disease Phase 2
- Benign muscle neoplasm Phase 3
- Breast cancer Phase 3
- Breast carcinoma Phase 3
- Cancer Phase 2
- Chronic myeloid leukemia Phase 2
- Chronic myelomonocytic leukemia Phase 2
- Endometriosis Phase 3
- Fibrolamellar hepatocellular carcinoma Phase 2
- HIV infectious disease Phase 1
- Hypogonadism Phase 2
- Infertility disorder Phase 3
- Leiomyoma Phase 3
- Liver cancer Phase 2
- Melanoma Phase 2
- Metastatic prostate carcinoma Phase 3
- Myelodysplastic syndrome Phase 2
- Obesity disorder Phase 1
Other linked conditions (6)
- Adenomyosis
- Central precocious puberty
- Hemangioma
- Obstructive sleep apnea syndrome
- Polycystic ovary syndrome
- Salivary gland cancer
Targets (1)
- GNRHR Gonadotropin-releasing hormone receptor agonist