Overview
Isosorbide was previously available in an oral formulation for the reduction of intraocular pressure. It was approved by the FDA in 1980, but has since been discontinued. Currently, isosorbide is an organic nitrate currently available in the isosorbide mononitrate and isosorbide dinitrate forms, and is used for the prevention of angina. Refer to these drug entries for more information.
Background
Isosorbide was previously available in an oral formulation for the reduction of intraocular pressure. It was approved by the FDA in 1980, but has since been discontinued. Currently, isosorbide is an organic nitrate currently available in the isosorbide mononitrate and isosorbide dinitrate forms, and is used for the prevention of angina. Refer to these drug entries for more information.
Indication
Isosorbide was previously indicated for temporary reduction of intraocular pressure and used to interrupt an acute glaucoma attack, however, this is not a currently approved indication. Refer to isosorbide mononitrate and isosorbide dinitrate drug entries for more isosorbide indications.
Associated Conditions
- Angina Pectoris
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2020/12/10 | Phase 4 | UNKNOWN | |||
2020/07/23 | Early Phase 1 | UNKNOWN | |||
2020/06/11 | Not Applicable | UNKNOWN | Air Force Military Medical University, China | ||
2020/03/17 | Phase 3 | UNKNOWN | |||
2020/03/17 | Phase 4 | Completed | |||
2020/01/06 | Not Applicable | Completed | |||
2020/01/03 | Not Applicable | Completed | |||
2018/05/14 | Phase 1 | UNKNOWN | Dina Yahia Mansour | ||
2018/03/02 | Phase 2 | Completed | |||
2017/08/21 | Phase 1 | Completed |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| No FDA approvals found for this drug. | |||||
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 |
|---|---|---|---|---|---|
| Isosorbitol Oral Solution | 国药准字H10960126 | 化学药品 | 口服溶液剂 | 1/22/2020 |
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. | |||||