Overview
Tolvaptan is used to treat low blood sodium levels (hyponatremia) associated with various conditions like congestive heart failure, cirrhosis, and syndrome of inappropriate antidiuretic hormones (SIADH). FDA approved on May 19, 2009.
Indication
Treatment of symptomatic and resistant to fluid restriction euvolemic or hypervolemic hyponatremia associated with congestive heart failure, SIADH, and cirrhosis.
Associated Conditions
- Autosomal Dominant Polycystic Kidney Disease （ADPKD)
- Symptomatic euvolemic Hyponatremia
- Symptomatic hypervolemic Hyponatremia
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2025/08/24 | Not Applicable | Not yet recruiting | |||
2025/08/03 | N/A | Completed | NanoAlvand | ||
2025/06/29 | Not Applicable | Active, not recruiting | |||
2024/11/21 | Phase 2 | Recruiting | |||
2024/11/15 | Early Phase 1 | Not yet recruiting | Beijing Tiantan Hospital | ||
2024/11/14 | N/A | ENROLLING_BY_INVITATION | |||
2024/11/13 | Phase 4 | Not yet recruiting | |||
2024/10/23 | Phase 3 | Not yet recruiting | |||
2024/10/03 | Phase 4 | Not yet recruiting | Post Graduate Institute of Medical Education and Research, Chandigarh | ||
2024/08/27 | N/A | Recruiting | Second Affiliated Hospital, School of Medicine, Zhejiang University |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Otsuka America Pharmaceutical, Inc. | 59148-021 | ORAL | 30 mg in 1 1 | 4/30/2021 | |
| Apotex Corp. | 60505-4317 | ORAL | 15 mg in 1 1 | 12/15/2023 | |
| Par Pharmaceutical, Inc. | 49884-770 | ORAL | 30 mg in 1 1 | 3/10/2022 | |
| Camber Pharmaceuticals, Inc. | 31722-869 | ORAL | 30 mg in 1 1 | 9/5/2022 | |
| Ascend Laboratories, LLC | 67877-637 | ORAL | 60 mg in 1 1 | 9/7/2022 | |
| Lupin Pharmaceuticals, Inc. | 70748-238 | ORAL | 15 mg in 1 1 | 5/9/2025 | |
| Camber Pharmaceuticals, Inc. | 31722-868 | ORAL | 15 mg in 1 1 | 9/5/2022 | |
| Ascend Laboratories, LLC | 67877-636 | ORAL | 30 mg in 1 1 | 9/7/2022 | |
| Pfizer Laboratories Div Pfizer Inc | 0069-0501 | ORAL | 11 mg in 1 1 | 5/23/2023 | |
| Novadoz Pharmaceuticals LLC | 72205-131 | ORAL | 30 mg in 1 1 | 3/31/2023 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
Authorised | 5/27/2015 | ||
Authorised | 5/27/2015 | ||
Authorised | 5/27/2015 | ||
Authorised | 5/27/2015 | ||
Authorised | 8/2/2009 | ||
Authorised | N/A | ||
Authorised | 3/22/2017 | ||
Authorised | 8/2/2009 | ||
Authorised | 3/22/2017 |
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| JINARC TABLET 45MG/15MG | SIN16609P | TABLET | 45.0mg | 9/23/2022 | |
| JINARC TABLET 60MG/30MG | SIN16610P | TABLET | 30.000mg | 9/23/2022 | |
| JINARC TABLET 30MG | SIN16608P | TABLET | 30.000mg | 9/23/2022 | |
| XELJANZ TABLET 5MG | SIN14664P | TABLET, FILM COATED | 8.078mg | 11/17/2014 | |
| JINARC TABLET 90MG/30MG | SIN16611P | TABLET | 90.0mg | 9/23/2022 | |
| JINARC TABLET 15MG | SIN16607P | TABLET | 15mg | 9/23/2022 | |
| SAMSCA TABLET 15MG | SIN15934P | TABLET | 15mg | 4/24/2020 | |
| JINARC TABLET 45MG/15MG | SIN16609P | TABLET | 15.000mg | 9/23/2022 | |
| JINARC TABLET 60MG/30MG | SIN16610P | TABLET | 60.000mg | 9/23/2022 | |
| JINARC TABLET 90MG/30MG | SIN16611P | TABLET | 30.000mg | 9/23/2022 |
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 |
|---|---|---|---|---|---|
| JINARC tolvaptan 30 mg + 90 mg tablet blister composite pack | 272789 | Medicine | A | 3/24/2017 | |
| TOLVAPTAN GH tolvaptan 30 mg + 90 mg tablet blister composite pack | 417518 | Medicine | A | 10/30/2024 | |
| TOLVAPTAN GH tolvaptan 30 mg + 60 mg tablet blister composite pack | 417519 | Medicine | A | 10/30/2024 | |
| XELJANZ tofacitiinib (as citrate) 1mg/mL oral solution bottle | 386772 | Medicine | A | 1/25/2023 | |
| JINARC tolvaptan 30 mg + 60 mg tablet blister composite pack | 272788 | Medicine | A | 3/24/2017 | |
| TOLVAPTAN LUPIN tolvaptan 15 mg + 45 mg tablet blister composite pack | 417526 | Medicine | A | 10/30/2024 | |
| JINARC tolvaptan 30 mg tablet blister pack | 272786 | Medicine | A | 3/24/2017 | |
| TOLVAPTAN LUPIN tolvaptan 30 mg + 90 mg tablet blister composite pac | 417524 | Medicine | A | 10/30/2024 | |
| TOLVAPTAN GH tolvaptan 30 mg tablet blister pack | 417525 | Medicine | A | 10/30/2024 | |
| SAMSCA tolvaptan 30 mg tablet blister pack | 176601 | Medicine | A | 4/5/2012 |
Health Canada Drug Approvals
Approved Product | Company | DIN | Dosage Form | Strength | Market Date |
|---|---|---|---|---|---|
| LUPIN-TOLVAPTAN | lupin pharma canada limited | 02557177 | Tablet - Oral | 15 MG | N/A |
| LUPIN-TOLVAPTAN | lupin pharma canada limited | 02557207 | Tablet - Oral | 60 MG | N/A |
| LUPIN-TOLVAPTAN | lupin pharma canada limited | 02557207 | Tablet - Oral | 30 MG | N/A |
| LUPIN-TOLVAPTAN | lupin pharma canada limited | 02557185 | Tablet - Oral | 15 MG | N/A |
| LUPIN-TOLVAPTAN | lupin pharma canada limited | 02557185 | Tablet - Oral | 30 MG | N/A |
| SAMSCA | 02370476 | Tablet - Oral | 30 MG | 9/22/2011 | |
| JINARC | 02491583 | Tablet - Oral | 15 MG | 3/26/2020 | |
| JINARC | 02491583 | Tablet - Oral | 30 MG | 3/26/2020 | |
| SAMSCA | 02370484 | Tablet - Oral | 60 MG | N/A | |
| SAMSCA | 02370468 | Tablet - Oral | 15 MG | 9/22/2011 |
CIMA AEMPS Drug Approvals
Approved Product | Company | Registration Number | Pharmaceutical Form | Prescription Type | Status |
|---|---|---|---|---|---|
| JINARC 30 mg + 60 mg COMPRIMIDOS | 1151000008 | COMPRIMIDO | Diagnóstico Hospitalario | Not Commercialized | |
| TOLVAPTAN TEVA 15 MG COMPRIMIDOS EFG | 84994 | COMPRIMIDO | Diagnóstico Hospitalario | Commercialized | |
| JINARC 30 mg + 60 mg comprimidos | 1151000010 | COMPRIMIDO | Diagnóstico Hospitalario | Commercialized | |
| JINARC 15 mg COMPRIMIDOS | 1151000001 | COMPRIMIDO | Diagnóstico Hospitalario | Commercialized | |
| TOLVAPTAN TEVA 15 MG + TOLVAPTAN TEVA 45 MG COMPRIMIDOS EFG | 84993 | COMPRIMIDO | Diagnóstico Hospitalario | Commercialized | |
| TOLVAPTAN TEVAGEN 30 MG COMPRIMIDOS EFG | 84995 | COMPRIMIDO | Medicamento Sujeto A Prescripción Médica | Commercialized | |
| JINARC 30 mg COMPRIMIDOS | 1151000003 | COMPRIMIDO | Diagnóstico Hospitalario | Commercialized | |
| TOLVAPTAN ACCORD 7,5 MG COMPRIMIDOS EFG | 1231719002 | COMPRIMIDO | Diagnóstico Hospitalario | Commercialized | |
| TOLVAPTAN TEVA 30 MG COMPRIMIDOS EFG | 84992 | COMPRIMIDO | Diagnóstico Hospitalario | Commercialized | |
| SAMSCA 7,5 MG COMPRIMIDOS | 109539007 | COMPRIMIDO | Medicamento Sujeto A Prescripción Médica | 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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