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 |
|---|---|---|---|---|---|
2025/06/29 | 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 | ||
2024/07/18 | Phase 1 | Not yet recruiting | |||
2024/07/12 | Phase 4 | Recruiting | Shanghai Zhongshan Hospital |
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 | 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 |
|---|---|---|---|---|---|
| Tolvaptan Tablets | 国药准字H20110116 | 化学药品 | 片剂 | 2/1/2021 | |
| Tolvaptan Tablets | 国药准字H20234203 | 化学药品 | 片剂 | 9/28/2023 | |
| Tolvaptan Tablets | 国药准字H20234204 | 化学药品 | 片剂 | 9/28/2023 | |
| Tolvaptan Tablets | 国药准字H20233074 | 化学药品 | 片剂 | 1/19/2023 | |
| Tolvaptan Tablets | 国药准字H20223417 | 化学药品 | 片剂 | 6/23/2022 | |
| Tolvaptan Tablets | 国药准字H20213152 | 化学药品 | 片剂 | 3/2/2021 | |
| Tolvaptan Tablets | 国药准字H20213153 | 化学药品 | 片剂 | 3/2/2021 | |
| Tolvaptan Tablets | 国药准字H20233073 | 化学药品 | 片剂 | 1/19/2023 | |
| Tolvaptan Tablets | 国药准字H20213392 | 化学药品 | 片剂 | 5/19/2021 | |
| Tolvaptan Tablets | 国药准字H20110115 | 化学药品 | 片剂 | 1/19/2021 |
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 |
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