> Trialight public data. Index of pages: https://trialight.com/llms.txt
> Web page: https://trialight.com/data/asset/leuprolide-acetate-69c5b838-1510-4a84-a80f-f227002be449
> Record changed: 2026-10-13

# Leuprolide acetate

Highest phase reached

Approved

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1200775)

Drug type

Protein

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1200775)

First approval year

1985

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1200775)

## Development status

**First approval year**

1985

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1200775)

**Listing at source**

Listed

**Highest phase reached**

Approved

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1200775)

## Names and chemistry

**Drug type**

Protein

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1200775)

**Drug name**

Leuprolide acetate

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1200775)

**Molecular weight**

1,269.47

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1200775)

**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

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1200775)

### Brand names (21)

- 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

### Other names (64)

- 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.

## Identifiers

**CAS registry numbers**

- 74381-53-6

**ChEMBL ID**

CHEMBL1200775

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1200775)

**InChIKey**

RGLRXNKKBLIBQS-XNHQSDQCSA-N

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1200775)

**PubChem compound IDs**

- 657180

**RxNorm IDs (RxCUI)**

- 203217

**FDA ingredient codes (UNII)**

- 37JNS02E7V

## Regulatory information

### United States

**Applicant**

TOLMAR

**Approval date**

23 Jan 2002

**Application number**

NDA021343

### Other regulatory facts

**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

### Drug classification

**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

### Investigated indications (25)

- **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

### Open Targets indications (58)

- **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.

### Reported adverse events (26)

- **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.

### Trial references (80)

- NCT00002580  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00002580)
- NCT00002582  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00002582)
- NCT00498901  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00498901)
- NCT01546649  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01546649)
- NCT01674140  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01674140)
- NCT02592746  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT02592746)
- NCT03664895  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT03664895)
- NCT03900637  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT03900637)
- NCT04711252  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04711252)
- NCT04964934  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04964934)
- NCT00003517  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00003517)
- NCT00075192  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00075192)
- NCT00170157  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00170157)
- NCT00512668  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00512668)
- NCT00544830  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00544830)
- NCT00589472  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00589472)
- NCT00937768  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00937768)
- NCT01023061  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01023061)
- NCT01120236  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01120236)
- NCT01122121  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01122121)
- NCT01163084  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01163084)
- NCT01431391  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01431391)
- NCT01786265  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01786265)
- NCT02023463  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT02023463)
- NCT02058706  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT02058706)

And 55 more, listed on the interactive page.

## Dosing

**Dose**

1 mg

**Route**

Subcutaneous

**How often**

Once daily

### Conditions of use (2)

- Inspect solution before use
- Vary injection site periodically

## Chemical properties

**Prodrug**

No

**Chirality**

Single enantiomer

**Inorganic**

No

**Heavy atoms**

91

**Molecular formula**

C61H88N16O14

**Monoisotopic mass**

1268.66659154

**Natural product**

No

## National Drug Codes

- 42023-259
- 62935-163
- 62935-227
- 62935-306
- 62935-461
- 62935-756
- 85043-025
- 85043-030
- 85043-045
- 85043-075

## Evidence counts

**Recorded assays**

205

**Active assays**

0

## 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 (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](https://trialight.com/data/condition/metastatic-prostate-carcinoma-d5fb1084-bad5-5db6-8240-897dc47ea451.md)
- Precocious puberty
- [Prostate adenocarcinoma](https://trialight.com/data/condition/prostate-adenocarcinoma-84e3e3af-1ae1-5760-8157-8d9fc0cff608.md)
- [Prostate cancer](https://trialight.com/data/condition/prostate-cancer-3659fc70-617b-5868-a093-ae819ffc6755.md)
- [Prostate carcinoma](https://trialight.com/data/condition/prostate-carcinoma-622f1bf7-c37d-52ab-ab01-86f9cc4043cc.md)

### In development for (18)

- [Alzheimer disease](https://trialight.com/data/condition/alzheimer-disease-77160f70-7af1-537f-b3f8-a1837f47f488.md) Phase 2
- [Breast cancer](https://trialight.com/data/condition/breast-cancer-8ac10da3-93bd-54c5-a93b-265bc6699689.md) Phase 3
- [Breast neoplasm](https://trialight.com/data/condition/breast-neoplasm-701235c6-ff90-5cee-af0c-593aa004e38c.md) Phase 3
- Bulimia nervosa Phase 2
- [Cancer](https://trialight.com/data/condition/cancer-703b1dfc-4812-50eb-83f4-d7a205d16bdb.md) Phase 3
- [Depressive disorder](https://trialight.com/data/condition/depressive-disorder-7618feda-3f90-5521-94e1-99f7100e8324.md) Phase 2
- [Endometriosis](https://trialight.com/data/condition/endometriosis-3a5471b6-6d24-50b8-b1e6-8803dd78b0db.md) Phase 3
- Hodgkins lymphoma Phase 2
- [Hypertensive disorder](https://trialight.com/data/condition/hypertensive-disorder-6d786557-b9e8-5afc-80f3-89a1995f9da5.md) Early phase 1
- Male infertility Phase 3
- Maligant granulosa cell tumor of ovary Phase 2
- [Mantle cell lymphoma](https://trialight.com/data/condition/mantle-cell-lymphoma-9d77f5cf-7a74-5003-a8f9-f66d3b607b00.md) Phase 2
- [Obesity disorder](https://trialight.com/data/condition/obesity-disorder-f3b57dc0-68ac-555c-8f13-0d81e595d9cb.md) Phase 3
- [Plasma cell myeloma](https://trialight.com/data/condition/plasma-cell-myeloma-37186689-2591-5775-9042-2f2bf046a2b5.md) 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](https://trialight.com/data/condition/prostate-neoplasm-28a8a0a9-1d2f-5539-80c9-7eb822c444fc.md)

### Targets (1)

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

---

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