> Trialight public data. Index of pages: https://trialight.com/llms.txt
> Web page: https://trialight.com/data/asset/leuprolide-dea24d3f-b6af-4051-826c-cf4e35258f7f
> Record changed: 2026-11-04

# Leuprolide

Highest phase reached

Approved

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1201199)

Drug type

Protein

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1201199)

First approval year

1985

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1201199)

## Development status

**First approval year**

1985

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1201199)

**Listing at source**

Listed

**Highest phase reached**

Approved

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1201199)

## Names and chemistry

**Drug type**

Protein

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1201199)

**Drug name**

Leuprolide

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1201199)

**Molecular weight**

1,209.42

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1201199)

**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

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1201199)

### Other names (49)

- (-)-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.

## Identifiers

**ATC classification codes**

- L02AE02

Sources for recorded values

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1201199)

**CAS registry numbers**

- 53714-56-0

**ChEMBL ID**

CHEMBL1201199

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1201199)

**InChIKey**

GFIJNRVAKGFPGQ-LIJARHBVSA-N

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1201199)

**PubChem compound IDs**

- 657181

**FDA ingredient codes (UNII)**

- EFY6W0M8TG

### RxNorm IDs (RxCUI) (2)

- 42375
- 203217

## Regulatory information

### United States

**Applicant**

ABBVIE ENDOCRINE INC

**Approval date**

9 Apr 1985

**Application number**

NDA019010

### Other regulatory facts

**First in class**

No

**Orphan designation**

No

**Availability**

Prescription only

## Approval status

**United States (FDA)**

Approved

## Pharmacology

### Drug classification

**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

### Investigated indications (21)

- **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

### Open Targets indications (46)

- **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.

### Reported adverse events (65)

- **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.

### Trial references (88)

- NCT00004054  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00004054)
- NCT00005044  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00005044)
- NCT00006359  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00006359)
- NCT00016913  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00016913)
- NCT00028769  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00028769)
- NCT00288080  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00288080)
- NCT00295750  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00295750)
- NCT00329043  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00329043)
- NCT00388804  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00388804)
- NCT00430183  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00430183)
- NCT00451958  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00451958)
- NCT00500110  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00500110)
- NCT00528866  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00528866)
- NCT00567580  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00567580)
- NCT00587431  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00587431)
- NCT00631527  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00631527)
- NCT00924469  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00924469)
- NCT00928434  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00928434)
- NCT00936390  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00936390)
- NCT01377389  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01377389)
- NCT01547299  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01547299)
- NCT01674270  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01674270)
- NCT01750398  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01750398)
- NCT02083185  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT02083185)
- NCT02085252  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT02085252)

And 63 more, listed on the interactive page.

## Dosing

**Dose**

1mg

**Route**

Subcutaneous

**How often**

Once daily

### Conditions of use

- Varied injection site periodically

## Chemical properties

**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

## Evidence counts

**Recorded assays**

200

**Active assays**

13

### Active assay types (2)

- Confirmatory
- Other

## Pharmacologic actions

- Fertility Agents, Female  
Source: [id.nlm.nih.gov](https://id.nlm.nih.gov/mesh/D005300.html)
- Antineoplastic Agents, Hormonal  
Source: [id.nlm.nih.gov](https://id.nlm.nih.gov/mesh/D018931.html)

## 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](https://trialight.com/data/condition/neoplasm-2a973797-359b-5982-907e-98f9b7c1a284.md)
- Prostate neoplasm

### In development for (26)

- [Acute lymphoblastic leukemia](https://trialight.com/data/condition/acute-lymphoblastic-leukemia-a7f89294-3477-5920-8fe1-8aa51fcd1d63.md) Phase 2
- [Acute myeloid leukemia](https://trialight.com/data/condition/acute-myeloid-leukemia-b0971a7a-c18d-544e-bd7f-b1a13b9caa30.md) Phase 2
- Autosomal dominant polycystic liver disease Phase 2
- Benign muscle neoplasm Phase 3
- [Breast cancer](https://trialight.com/data/condition/breast-cancer-8ac10da3-93bd-54c5-a93b-265bc6699689.md) Phase 3
- [Breast carcinoma](https://trialight.com/data/condition/breast-carcinoma-e447567c-405f-500c-a7a4-766a76d59293.md) Phase 3
- [Cancer](https://trialight.com/data/condition/cancer-703b1dfc-4812-50eb-83f4-d7a205d16bdb.md) Phase 2
- Chronic myeloid leukemia Phase 2
- [Chronic myelomonocytic leukemia](https://trialight.com/data/condition/chronic-myelomonocytic-leukemia-202fe88e-7b5d-5022-b6d2-095cac037e8e.md) Phase 2
- [Endometriosis](https://trialight.com/data/condition/endometriosis-3a5471b6-6d24-50b8-b1e6-8803dd78b0db.md) Phase 3
- Fibrolamellar hepatocellular carcinoma Phase 2
- [HIV infectious disease](https://trialight.com/data/condition/hiv-infectious-disease-1260f28c-d667-55f9-b221-15d5017fde05.md) Phase 1
- Hypogonadism Phase 2
- Infertility disorder Phase 3
- [Leiomyoma](https://trialight.com/data/condition/leiomyoma-f84b9cb4-e902-5ed0-bb93-4d36211170f3.md) Phase 3
- Liver cancer Phase 2
- [Melanoma](https://trialight.com/data/condition/melanoma-457e9de6-dcd9-56fb-be48-0290fb4386ef.md) Phase 2
- [Metastatic prostate carcinoma](https://trialight.com/data/condition/metastatic-prostate-carcinoma-d5fb1084-bad5-5db6-8240-897dc47ea451.md) Phase 3
- [Myelodysplastic syndrome](https://trialight.com/data/condition/myelodysplastic-syndrome-f5df8ce5-6064-53d3-902c-f09fc4acd4bb.md) Phase 2
- [Obesity disorder](https://trialight.com/data/condition/obesity-disorder-f3b57dc0-68ac-555c-8f13-0d81e595d9cb.md) Phase 1

### Other linked conditions (6)

- Adenomyosis
- Central precocious puberty
- Hemangioma
- [Obstructive sleep apnea syndrome](https://trialight.com/data/condition/obstructive-sleep-apnea-syndrome-02928491-a2d7-50f4-a4b7-30b79e6771ff.md)
- [Polycystic ovary syndrome](https://trialight.com/data/condition/polycystic-ovary-syndrome-441e4a14-977c-536f-a5ad-0c5be955054b.md)
- Salivary gland cancer

### Targets (1)

- [GNRHR](https://trialight.com/data/target/gnrhr-ac2ad3c8-85c9-5310-a5fb-e2b215542909.md) Gonadotropin-releasing hormone receptor agonist

---

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