Overview
Aliskiren is the first drug in the renin inhibitor drug class and is used for the treatment of hypertension. It was developed by Speedel and Novartis and initially approved by the FDA in early 2007. Aliskiren has been proven to efficacious in reducing blood pressure when used alone or in conjunction with other antihypertensive agents.
Indication
Aliskiren is used for the treatment of hypertension in children above 6 years and adults. This drug may also be used in conjunction with antihypertensives such as calcium channel blockers and thiazides in products form to provide additional blood pressure control.
Associated Conditions
- Hypertension
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2024/12/05 | Phase 4 | Completed | Hansung University | ||
2019/12/03 | Phase 2 | Recruiting | |||
2017/04/14 | Phase 4 | Completed | |||
2016/09/21 | Phase 3 | UNKNOWN | Mika Lehto | ||
2015/05/18 | Not Applicable | Completed | |||
2013/08/14 | Phase 4 | Withdrawn | |||
2013/07/09 | Phase 4 | UNKNOWN | |||
2013/04/09 | Phase 4 | Completed | |||
2012/10/26 | Phase 3 | Completed | |||
2012/07/09 | Phase 4 | UNKNOWN |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| LXO US Inc. | 70839-150 | ORAL | 150 mg in 1 1 | 3/7/2024 | |
| Noden Pharma USA, Inc. | 70839-112 | ORAL | 150 mg in 1 1 | 11/16/2022 | |
| LXO US Inc. | 70839-300 | ORAL | 300 mg in 1 1 | 3/7/2024 | |
| A-S Medication Solutions | 50090-2985 | ORAL | 300 mg in 1 1 | 12/21/2023 | |
| Par Pharmaceutical, Inc. | 49884-425 | ORAL | 300 mg in 1 1 | 3/25/2019 | |
| Noden Pharma USA, Inc. | 70839-325 | ORAL | 300 mg in 1 1 | 11/16/2022 | |
| Prasco Laboratories | 66993-142 | ORAL | 300 mg in 1 1 | 5/25/2023 | |
| Par Pharmaceutical, Inc. | 49884-424 | ORAL | 150 mg in 1 1 | 3/25/2019 | |
| Noden Pharma USA, Inc. | 70839-312 | ORAL | 300 mg in 1 1 | 11/16/2022 | |
| Noden Pharma USA, Inc. | 70839-125 | ORAL | 150 mg in 1 1 | 11/16/2022 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
Authorised | 8/22/2007 |
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. | |||||
Health Canada Drug Approvals
Approved Product | Company | DIN | Dosage Form | Strength | Market Date |
|---|---|---|---|---|---|
| No Health Canada approvals found for this drug. | |||||
CIMA AEMPS Drug Approvals
Approved Product | Company | Registration Number | Pharmaceutical Form | Prescription Type | Status |
|---|---|---|---|---|---|
| RASILEZ HCT 150 mg/12,5 mg COMPRIMIDOS RECUBIERTOS CON PELICULA | Noden Pharma Designated Activity Company | 08491012 | COMPRIMIDO RECUBIERTO CON PELÍCULA | Medicamento Sujeto A Prescripción Médica | Not Commercialized |
| RASILEZ 300 mg COMPRIMIDOS RECUBIERTOS CON PELICULA | Noden Pharma Designated Activity Company | 07405040 | COMPRIMIDO RECUBIERTO CON PELÍCULA | Medicamento Sujeto A Prescripción Médica | Not Commercialized |
| RASILEZ 300 mg COMPRIMIDOS RECUBIERTOS CON PELICULA | Noden Pharma Designated Activity Company | 07405020 | COMPRIMIDO RECUBIERTO CON PELÍCULA | Medicamento Sujeto A Prescripción Médica | Not Commercialized |
| RASILEZ 150 mg COMPRIMIDOS RECUBIERTOS CON PELICULA | Noden Pharma Designated Activity Company | 07405003 | COMPRIMIDO RECUBIERTO CON PELÍCULA | Medicamento Sujeto A Prescripción Médica | Not Commercialized |
| RASILEZ 150 mg COMPRIMIDOS RECUBIERTOS CON PELICULA | Noden Pharma Designated Activity Company | 07405010 | COMPRIMIDO RECUBIERTO CON PELÍCULA | Medicamento Sujeto A Prescripción Médica | Not Commercialized |
| RASILEZ HCT 150 mg/25 mg COMPRIMIDOS RECUBIERTOS CON PELICULA | Noden Pharma Designated Activity Company | 08491032 | COMPRIMIDO RECUBIERTO CON PELÍCULA | Medicamento Sujeto A Prescripción Médica | Not Commercialized |
| RASILEZ 300 mg COMPRIMIDOS RECUBIERTOS CON PELICULA | Noden Pharma Designated Activity Company | 07405013 | COMPRIMIDO RECUBIERTO CON PELÍCULA | Medicamento Sujeto A Prescripción Médica | Not Commercialized |
| RASILEZ 150 mg COMPRIMIDOS RECUBIERTOS CON PELICULA | Noden Pharma Designated Activity Company | 07405022 | COMPRIMIDO RECUBIERTO CON PELÍCULA | Medicamento Sujeto A Prescripción Médica | Commercialized |
| RASILEZ 150 mg COMPRIMIDOS RECUBIERTOS CON PELICULA | Noden Pharma Designated Activity Company | 07405030 | COMPRIMIDO RECUBIERTO CON PELÍCULA | Medicamento Sujeto A Prescripción Médica | Not Commercialized |
| RASILEZ HCT 300 mg/12,5 mg COMPRIMIDOS RECUBIERTOS CON PELICULA | Noden Pharma Designated Activity Company | 08491052 | COMPRIMIDO RECUBIERTO CON PELÍCULA | Medicamento Sujeto A Prescripción Médica | Not Commercialized |
Philippines FDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Philippines FDA approvals found for this drug. | |||||
Saudi SFDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Saudi SFDA approvals found for this drug. | |||||
Malaysia NPRA Drug Approvals
Approved Product | Company | Registration Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Malaysia NPRA approvals found for this drug. | |||||
UK EMC Drug Information
Medicine Name | MA Holder | MA Number | Pharmaceutical Form | Active Ingredient | Authorization Date |
|---|---|---|---|---|---|
| No UK EMC drug information found for this drug. | |||||
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