Overview
Nilutamide is an antineoplastic hormonal agent primarily used in the treatment of prostate cancer. Nilutamide is a pure, nonsteroidal anti-androgen with affinity for androgen receptors (but not for progestogen, estrogen, or glucocorticoid receptors). Consequently, Nilutamide blocks the action of androgens of adrenal and testicular origin that stimulate the growth of normal and malignant prostatic tissue. Prostate cancer is mostly androgen-dependent and can be treated with surgical or chemical castration. To date, antiandrogen monotherapy has not consistently been shown to be equivalent to castration.
Background
Nilutamide is an antineoplastic hormonal agent primarily used in the treatment of prostate cancer. Nilutamide is a pure, nonsteroidal anti-androgen with affinity for androgen receptors (but not for progestogen, estrogen, or glucocorticoid receptors). Consequently, Nilutamide blocks the action of androgens of adrenal and testicular origin that stimulate the growth of normal and malignant prostatic tissue. Prostate cancer is mostly androgen-dependent and can be treated with surgical or chemical castration. To date, antiandrogen monotherapy has not consistently been shown to be equivalent to castration.
Indication
用于已转移的前列腺癌，可与手术或化学去势合用。
Associated Conditions
- Metastatic Prostate Cancer
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2018/09/19 | Phase 3 | Recruiting | |||
2017/03/06 | Phase 2 | Active, not recruiting | |||
2013/02/07 | Phase 2 | Active, not recruiting | |||
2009/06/11 | Phase 2 | Terminated | |||
2007/08/08 | Phase 1 | Terminated | |||
2003/01/27 | Phase 3 | Completed | |||
2003/01/27 | Phase 3 | Completed | |||
2003/01/27 | Phase 3 | Completed | |||
2003/01/27 | Phase 2 | Completed | |||
2003/01/27 | Phase 2 | Completed |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Prasco Laboratories | 66993-212 | ORAL | 150 mg in 1 1 | 11/22/2019 | |
| ANI Pharmaceuticals, Inc. | 62559-173 | ORAL | 150 mg in 1 1 | 9/18/2020 | |
| Concordia Pharmaceuticals Inc. | 59212-111 | ORAL | 150 mg in 1 1 | 7/8/2022 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
| No EMA approvals found for this drug. | |||
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No HSA approvals found for this drug. | |||||
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| No NMPA approvals found for this drug. | |||||
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| No PPB approvals found for this drug. | |||||
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| No TGA approvals found for this drug. | |||||