Drugs / Isosorbide
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Approved | US (FDA) | ISMOTIC | — | 1974-01-30 | fda.gov ↗ |
Trials 2
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 2/31 trial | ||||||
| Phase 2/3 | NCT06765993 | Dec 2024 → Jun 2027 expected | Meniere disease | Lunan Better Pharmaceutical Co., LTD. | Not yet recruiting | No outcome recorded |
| Phase 41 trial | ||||||
| Phase 4 | NCT02718846 | Feb 2013 → May 2015 | Meniere disease | Alvogen Korea | Completed | No outcome recorded |
| Comparator or background therapy1 trial | ||||||
| Phase 4 | NCT01769079 Comparator | Sep 2009 → Dec 2013 | myocardial ischemia | Hospital de Clinicas de Porto Alegre | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 1
| Date | Issuer | Release |
|---|---|---|
| 2018-07-09 | Lunan Better Pharmaceutical Co., LTD. | Regulatory 鲁南制药又添三个原料药通过技术审评 lunan.com.cn ↗
近期，鲁南制药的硝酸异山梨酯、右旋布洛芬、阿加曲班通过国家市场监督管理总局（以下简称总局）技术审评 |
All press releases naming this drug 1 release
| Date | Issuer | Release |
|---|---|---|
| 2018-07-09 | Lunan Better Pharmaceutical Co., LTD. | 鲁南制药又添三个原料药通过技术审评 lunan.com.cn ↗ |
Evidence & citations 3 cited values
Every value below carries the sentence it was read from. 3 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Isosorbide | “Isosorbide” NCT01769079 ↗ |
| Known as | Isobide | ClinicalTrials.gov intervention name — accepted as the source's own label NCT02718846 ↗ |
| Route | Oral | “administered orally” NCT02718846 ↗ |