> Trialight public data. Index of pages: https://trialight.com/llms.txt
> Web page: https://trialight.com/data/asset/enzalutamide-d1214ac0-68e5-4752-9999-977e028ec483
> Record changed: 2026-10-13

# Enzalutamide

Highest phase reached

Approved

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1082407)

Drug type

Small molecule

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1082407)

First approval year

2012

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1082407)

## Development status

**First approval year**

2012

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1082407)

**Listing at source**

Listed

**Highest phase reached**

Approved

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1082407)

## Names and chemistry

**Drug type**

Small molecule

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1082407)

**Drug name**

Enzalutamide

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1082407)

**Molecular weight**

464.44

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1082407)

**Structure (SMILES)**

CNC(=O)c1ccc(N2C(=S)N(c3ccc(C#N)c(C(F)(F)F)c3)C(=O)C2(C)C)cc1F

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1082407)

### Brand names (2)

- xtandi
- Xtandi

### Other names (37)

- 177lu psma 617 plus enzalutamide
- enzalutamida
- Enzalutamida
- enzalutamide
- Enzalutamide
- Enzalutamide (Xtandi)
- Enzalutamide \[INN\]
- Enzalutamide \[JAN\]
- Enzalutamide \[MI\]
- Enzalutamide \[ORANGE BOOK\]
- Enzalutamide \[USAN\]
- Enzalutamide \[VANDF\]
- Enzalutamide \[WHO-DD\]
- Enzalutamide 160 mg
- Enzalutamide 160mg daily (oral)
- Enzalutamide 40 MG
- Enzalutamide 40 mg capsule
- Enzalutamide 40mg
- Enzalutamide capsule
- Enzalutamide Capsule
- enzalutamide inn
- enzalutamide jan
- enzalutamide mi
- Enzalutamide Oral Capsule
- Enzalutamide Oral Tablet

And 12 more, listed on the interactive page.

## Identifiers

**ATC classification codes**

- L02BB04

Sources for recorded values

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1082407)

**CAS registry numbers**

- 915087-33-1

**ChEMBL ID**

CHEMBL1082407

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1082407)

**InChIKey**

WXCXUHSOUPDCQV-UHFFFAOYSA-N

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1082407)

**PubChem compound IDs**

- 15951529

**RxNorm IDs (RxCUI)**

- 1307298

**FDA ingredient codes (UNII)**

- 93T0T9GKNU

## Regulatory information

### United States

**Applicant**

ASTELLAS

**Approval date**

31 Aug 2012

**Application number**

NDA203415

### European Union

**Status**

Authorised

**Status date**

21 Jun 2013

**Authorisation date**

21 Jun 2013

**Approved indications**

Xtandi is indicated for: as monotherapy or in combination with androgen deprivation therapy for the treatment of adult men with high risk biochemical recurrent (BCR) non-metastatic hormone sensitive prostate cancer (nmHSPC) who are unsuitable for salvage radiotherapy (see section 5.1). the treatment of adult men with metastatic hormone-sensitive prostate cancer (mHSPC) in combination with androgen deprivation therapy (see section 5.1). the treatment of adult men with high-risk non-metastatic castration-resistant prostate cancer (CRPC) (see section 5.1). the treatment of adult men with metastatic CRPC who are asymptomatic or mildly symptomatic after failure of androgen deprivation therapy in whom chemotherapy is not yet clinically indicated (see section 5.1). the treatment of adult men with metastatic CRPC whose disease has progressed on or after docetaxel therapy.

**Product number**

EMEA/H/C/002639

**Authorisation holder**

Astellas Pharma Europe B.V.

**Priority medicines scheme**

No

**Generic**

No

**Biosimilar**

No

**Generic medicines**

2

**Biosimilar medicines**

0

**Advanced therapy**

No

**Conditional approval**

No

**Additional monitoring**

No

**Accelerated assessment**

No

**Exceptional circumstances**

No

#### Therapeutic areas

- Prostatic Neoplasms

European medicines record

Source: [www.ema.europa.eu](https://www.ema.europa.eu/en/medicines/human/EPAR/xtandi)

### Other regulatory facts

**Patents**

11

**Designations**

2

**Earliest recorded loss of exclusivity**

23 Feb 2037

**First in class**

No

**Fast track**

Yes

**Breakthrough designation**

No

**Orphan designation**

No

**Priority review**

Yes

**Orphan exclusivity**

No

**Accelerated approval**

No

**Availability**

Prescription only

## Pharmacology

### Drug classification

**Pharmacology name**

enzalutamide

**Type**

Synthetic organic

**Drug name stem**

\-lutamide

**Approval recorded by Guide to Pharmacology**

Yes

#### Administration routes

- Oral

### Mechanisms of action (2)

- **Action**  
Antagonist

**Action type**  
Antagonist

**Target**  
Androgen receptor

**Gene symbol**  
AR

**Protein identifier**  
P10275

**Median affinity**

7.44

**Affinity units**  
pIC50

**Primary target**  
Yes
- **Mechanism**  
Androgen Receptor antagonist

**Action type**  
Antagonist

**Target**  
Androgen receptor

**Protein identifier**  
P10275

### Open Targets mechanisms

- **Mechanism**  
Androgen Receptor antagonist

**Action type**  
Antagonist

**Target**  
Androgen receptor

### DrugCentral mechanisms

- **Action type**  
Antagonist

**Gene symbol**  
AR

**Protein identifier**  
P10275

**Organism**  
Homo sapiens

**Target development level**  
Clinical

### Investigated indications (23)

- **Condition**  
Carcinoma, Hepatocellular

**Highest recorded phase**  
2

**Condition identifier**  
EFO:0000182

**Subject identifier**  
D006528
- **Condition**  
Prostatic Neoplasms

**Highest recorded phase**  
4

**Condition identifier**  
EFO:0000196

**Subject identifier**  
D011471
- **Condition**  
Adenocarcinoma

**Highest recorded phase**  
2

**Condition identifier**  
EFO:0000228

**Subject identifier**  
D000230
- **Condition**  
Breast Neoplasms

**Highest recorded phase**  
3

**Condition identifier**  
EFO:0000305

**Subject identifier**  
D001943
- **Condition**  
Carcinoma

**Highest recorded phase**  
2

**Condition identifier**  
EFO:0000313

**Subject identifier**  
D002277
- **Condition**  
Carcinoma, Renal Cell

**Highest recorded phase**

0.5

**Condition identifier**  
EFO:0000349

**Subject identifier**  
D002292
- **Condition**  
Neoplasms

**Highest recorded phase**  
4

**Condition identifier**  
EFO:0000616

**Subject identifier**  
D009369
- **Condition**  
Prostatic Neoplasms

**Highest recorded phase**  
4

**Condition identifier**  
EFO:0000673

**Subject identifier**  
D011471
- **Condition**  
Liver Diseases

**Highest recorded phase**  
1

**Condition identifier**  
EFO:0001421

**Subject identifier**  
D008107
- **Condition**  
Prostatic Neoplasms

**Highest recorded phase**  
4

**Condition identifier**  
EFO:0001663

**Subject identifier**  
D011471
- **Condition**  
Pancreatic Neoplasms

**Highest recorded phase**  
1

**Condition identifier**  
EFO:0002618

**Subject identifier**  
D010190
- **Condition**  
Kidney Diseases

**Highest recorded phase**  
1

**Condition identifier**  
EFO:0003086

**Subject identifier**  
D007674
- **Condition**  
Uterine Neoplasms

**Highest recorded phase**  
2

**Condition identifier**  
EFO:0003859

**Subject identifier**  
D014594
- **Condition**  
Triple Negative Breast Neoplasms

**Highest recorded phase**  
2

**Condition identifier**  
EFO:0005537

**Subject identifier**  
D064726
- **Condition**  
Endometrial Neoplasms

**Highest recorded phase**  
2

**Condition identifier**  
EFO:0007532

**Subject identifier**  
D016889
- **Condition**  
Lymphoma, Mantle-Cell

**Highest recorded phase**  
2

**Condition identifier**  
EFO:1001469

**Subject identifier**  
D020522
- **Condition**  
Urinary Bladder Neoplasms

**Highest recorded phase**  
2

**Condition identifier**  
MONDO:0001187

**Subject identifier**  
D001749
- **Condition**  
Neoplasms

**Highest recorded phase**  
4

**Condition identifier**  
MONDO:0004992

**Subject identifier**  
D009369
- **Condition**  
Breast Neoplasms

**Highest recorded phase**  
3

**Condition identifier**  
MONDO:0007254

**Subject identifier**  
D001943
- **Condition**  
Ovarian Neoplasms

**Highest recorded phase**  
2

**Condition identifier**  
MONDO:0008170

**Subject identifier**  
D010051
- **Condition**  
Prostatic Neoplasms

**Highest recorded phase**  
4

**Condition identifier**  
MONDO:0008315

**Subject identifier**  
D011471
- **Condition**  
Prostatic Neoplasms

**Highest recorded phase**  
4

**Condition identifier**  
MONDO:0021259

**Subject identifier**  
D011471
- **Condition**  
Severe Acute Respiratory Syndrome

**Highest recorded phase**  
2

**Condition identifier**  
MONDO:0100096

**Subject identifier**  
D045169

### Open Targets indications (50)

- **Condition identifier**  
EFO\_0000182

**Highest recorded phase**  
2
- **Condition identifier**  
EFO\_0000196

**Highest recorded phase**  
3
- **Condition identifier**  
EFO\_0000228

**Highest recorded phase**  
2
- **Condition identifier**  
EFO\_0000305

**Highest recorded phase**  
2
- **Condition identifier**  
EFO\_0000313

**Highest recorded phase**  
2
- **Condition identifier**  
EFO\_0000349
- **Condition identifier**  
EFO\_0000616
- **Condition identifier**  
EFO\_0000673

**Highest recorded phase**  
3
- **Condition identifier**  
EFO\_0001421

**Highest recorded phase**  
1
- **Condition identifier**  
EFO\_0001663
- **Condition identifier**  
EFO\_0003086

**Highest recorded phase**  
1
- **Condition identifier**  
EFO\_0005537

**Highest recorded phase**  
2
- **Condition identifier**  
EFO\_0009782

**Highest recorded phase**  
2
- **Condition identifier**  
EFO\_0009870

**Highest recorded phase**  
2
- **Condition identifier**  
EFO\_1001469

**Highest recorded phase**  
2
- **Condition identifier**  
MONDO\_0001187

**Highest recorded phase**  
1
- **Condition identifier**  
MONDO\_0001187

**Highest recorded phase**  
2
- **Condition identifier**  
MONDO\_0002158

**Highest recorded phase**  
2
- **Condition identifier**  
MONDO\_0002447

**Highest recorded phase**  
1
- **Condition identifier**  
MONDO\_0002691

**Highest recorded phase**  
1
- **Condition identifier**  
MONDO\_0003330

**Highest recorded phase**  
2
- **Condition identifier**  
MONDO\_0004669

**Highest recorded phase**  
2
- **Condition identifier**  
MONDO\_0004956

**Highest recorded phase**  
4
- **Condition identifier**  
MONDO\_0004992

**Highest recorded phase**  
2
- **Condition identifier**  
MONDO\_0005005

**Highest recorded phase**  
1

And 25 more, listed on the interactive page.

### Reported adverse events (10)

- **Event**  
asthenia

**Reports**  
589

**Reporting signal score**

285.688
- **Event**  
back pain

**Reports**  
300

**Reporting signal score**

121.287
- **Event**  
decreased appetite

**Reports**  
502

**Reporting signal score**

421.754
- **Event**  
dysphagia

**Reports**  
359

**Reporting signal score**

357.877
- **Event**  
fatigue

**Reports**  
1,436

**Reporting signal score**

982.902
- **Event**  
hot flush

**Reports**  
298

**Reporting signal score**

446.048
- **Event**  
malignant neoplasm progression

**Reports**  
1,431

**Reporting signal score**  
3,753.53
- **Event**  
metastases to bone

**Reports**  
104

**Reporting signal score**

161.902
- **Event**  
prostate cancer

**Reports**  
145

**Reporting signal score**

253.046
- **Event**  
prostatic specific antigen increased

**Reports**  
751

**Reporting signal score**  
2,945.8

### Trial references (108)

- NCT01284920  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01284920)
- NCT02319837  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT02319837)
- NCT02384382  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT02384382)
- NCT02507570  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT02507570)
- NCT02640534  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT02640534)
- NCT03196388  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT03196388)
- NCT03314324  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT03314324)
- NCT03344211  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT03344211)
- NCT03531827  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT03531827)
- NCT03999515  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT03999515)
- NCT04455750  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04455750)
- NCT04471974  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04471974)
- NCT05037500  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05037500)
- NCT05191017  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05191017)
- NCT05730712  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05730712)
- NCT05733351  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05733351)
- NCT05818683  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05818683)
- NCT06236139  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06236139)
- NCT01288911  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01288911)
- NCT01927627  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01927627)
- NCT01949337  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01949337)
- NCT02023463  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT02023463)
- NCT02034552  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT02034552)
- NCT02058706  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT02058706)
- NCT02203695  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT02203695)

And 83 more, listed on the interactive page.

## Dosing

**Dose**

160 mg

**Route**

Oral

**How often**

Once daily

### Conditions of use (3)

- Do not chew, dissolve, or open the capsules
- Do not cut, crush, or chew the tablets
- Take with or without food

## Chemical properties

**Hydrogen bond acceptors**

4

**Hydrogen bond donors**

1

**Polar surface area**

76.44

**Calculated partition coefficient (ALogP)**

3.99

**Calculated partition coefficient (XLogP)**

3.6

**Prodrug**

No

**Chirality**

Achiral

**Inorganic**

No

**Rule-of-five violations**

0

**Rotatable bonds**

3

**Heavy atoms**

32

**Molecular formula**

C21H16F4N4O2S

**Monoisotopic mass**

464.09300959

**Natural product**

No

## National Drug Codes

- 0469-0125
- 0469-0625
- 0469-0725
- 0469-1125
- 0469-1725

## Evidence counts

**Recorded assays**

1,936

**Active assays**

204

### Active assay types (3)

- Confirmatory
- Other
- Screening

## Biological measurements

These details could not be displayed.

## Related records

### Trials (334)

- 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 Ifinatamab Deruxtecan Based Treatment Combinations or as Monotherapy to Treat Metastatic Castrate Resistant Prostate Cancer (mCRPC) (MK-2400-01A/IDeate-Prostate02)](https://trialight.com/data/trial/a-clinical-study-of-ifinatamab-deruxtecan-based-treatment-99be48a0-44f7-46eb-bdf5-d3d2adc6018e.md)
- A Clinical Study of QLC5508 and/or QLH12016 in Combination With Other Anti-tumor Therapies in Subjects With Advanced Prostate Cancer
- A Dose Optimization Study of Enzalutamide in Elderly Patients With Advanced Prostate Cancer
- A Multi-centre Study to Assess the Safety, Tolerability, and Pharmacokinetics of Capivasertib (AZD5363) in Combination With Novel Agents in Patients With Metastatic Prostate Cancer
- A Phase 1 Clinical Study of AZD4635 in Patients With Advanced Solid Malignancies
- A Phase 1 Study of MDV3100 in Patients With Castration-Resistant (Hormone-Refractory) Prostate Cancer
- A Phase 1/1b Study of MEDI3726 in Adults Subjects With Metastatic Castration Resistant Prostate Cancer
- [A Phase 1/2a Study of DB-1311/BNT324 in Advanced/Metastatic Solid Tumors](https://trialight.com/data/trial/a-phase-1-2a-study-of-db-1311-bnt324-in-advanced-metastatic-b09e4d50-e189-4c38-848b-2e45efa5d49d.md)
- A Phase I/IIa Trial of HMBD-001 in Advanced HER3 Positive Solid Tumours
- A Phase Ib/II Open-label Study of AMO959 With Lutetium (177Lu) Vipivotide Tetraxetan (AAA617) in Combination With ARPI in Adult Participants With PSMA-positive mCRPC
- A Phase II Neoadjuvant Study of Enzalutamide, Abiraterone Acetate, Dutasteride and Degarelix in Men With Localized Prostate Cancer Pre-prostatectomy
- A Phase II Study Evaluating the Efficacy of Enzalutamide and the Role of ARv7 in Metastatic Castration Resistant Prostate Cancer (mCRPC) Patients With Visceral Disease.
- A Phase III Clinical Study of Rezvilutamide in Patients With Metastatic Hormone-Sensitive Prostate Cancer
- A Phase III Study Comparing HRS-4357 With Novel Androgen Receptor Pathway Inhibitors in Patients With Progressive, PSMA-Positive Metastatic Castration-Resistant Prostate Cancer
- A Positron Emission Tomography/Computed Tomography (PET/CT) Bone Imaging Study in Patients Receiving Enzalutamide for Castration-Resistant Prostate Cancer (CRPC)
- A Randomized Phase IIa Efficacy and Safety Study of Radium-223 Dichloride With Abiraterone Acetate or Enzalutamide in Metastatic Castration-resistant Prostate Cancer (CRPC)
- A Randomized Study of Enzalutamide in Patients With Localized Prostate Cancer Undergoing Active Surveillance
- A Registry Based Study Evaluating Overall Survival and Treatment Length in mCRPC Patients Treated With Enzalutamide in Sweden
- A Registry Study to Observe Clinical Outcomes of Participants With High-risk Metastatic Hormone-naïve Prostate Cancer in Japan

### Approved for (7)

- [Cancer](https://trialight.com/data/condition/cancer-703b1dfc-4812-50eb-83f4-d7a205d16bdb.md)
- [Metastatic prostate carcinoma](https://trialight.com/data/condition/metastatic-prostate-carcinoma-d5fb1084-bad5-5db6-8240-897dc47ea451.md)
- Neoplasm
- [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)
- [Prostate neoplasm](https://trialight.com/data/condition/prostate-neoplasm-28a8a0a9-1d2f-5539-80c9-7eb822c444fc.md)

### In development for (16)

- [Adenocarcinoma](https://trialight.com/data/condition/adenocarcinoma-b5c321d1-7c49-5bf9-abd0-dfa99dbd5f29.md) Phase 2
- [Breast cancer](https://trialight.com/data/condition/breast-cancer-8ac10da3-93bd-54c5-a93b-265bc6699689.md) Phase 3
- Breast carcinoma Phase 3
- [Carcinoma](https://trialight.com/data/condition/carcinoma-575e4c82-5fa5-5455-b1b7-30972eca1a2f.md) Phase 2
- [Clear cell renal carcinoma](https://trialight.com/data/condition/clear-cell-renal-carcinoma-789eee25-ec64-5771-9b7d-d19544781b11.md) Early phase 1
- [COVID-19](https://trialight.com/data/condition/covid-19-13f0ebf3-c291-557d-bdef-93563d077103.md) Phase 2
- Exocrine pancreatic carcinoma Phase 1
- [Hepatocellular carcinoma](https://trialight.com/data/condition/hepatocellular-carcinoma-fc1014ac-5a3c-551d-98ea-95306009e299.md) Phase 2
- [Kidney disorder](https://trialight.com/data/condition/kidney-disorder-e50371fe-f1a7-53fe-9cfb-9d6da9130e3c.md) Phase 1
- [Liver disorder](https://trialight.com/data/condition/liver-disorder-8388d30a-2581-5015-9ddf-adc5f6a331d7.md) Phase 1
- [Mantle cell lymphoma](https://trialight.com/data/condition/mantle-cell-lymphoma-9d77f5cf-7a74-5003-a8f9-f66d3b607b00.md) Phase 2
- [Ovarian cancer](https://trialight.com/data/condition/ovarian-cancer-f64f2018-55a5-553a-8960-76cb4906aa17.md) Phase 2
- [Triple-negative breast carcinoma](https://trialight.com/data/condition/triple-negative-breast-carcinoma-059174a2-9b5f-5234-90b9-4a4fee6eb9bb.md) Phase 2
- [Tumor of uterus](https://trialight.com/data/condition/tumor-of-uterus-0e35fef4-f54a-5086-aa67-9cd577110fd7.md) Phase 2
- Urinary bladder cancer Phase 2
- Uterine corpus cancer Phase 2

### Targets (1)

- [AR](https://trialight.com/data/target/ar-a6af2dca-1d81-5967-9bce-dc5b29aacbbc.md) Androgen Receptor antagonist

---

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