Drugs / Ioflupane
Ioflupane
Trials 2
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 1/21 trial · 1 missed | ||||||
| Phase 1/2 | NCT03675282 | Aug 2018 → Apr 2024 | Parkinson disease, REM sleep behavior disorder | Weill Medical College of Cornell University | Completed | Missed primary |
| Phase 31 trial | ||||||
| Phase 3 | NCT00209456 | Nov 2003 → ? | Alzheimer disease, Lewy body dementia, vascular dementia | GE Healthcare | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 3
| Date | Issuer | Release |
|---|---|---|
| 2022-11-03 | GE Healthcare | Regulatory DATSCAN™ (Ioflupane I 123 Injection) indication expanded to include use in patients with suspected Dementia with Lewy Bodies (DLB) gehealthcare.com ↗
DaTscan has been approved by the U.S. Food and Drug Administration (FDA) for use in patients with suspected Dementia with Lewy Bodies (DLB). |
| 2022-04-05 | Curium US LLC | Regulatory Curium Announces FDA Approval of a Generic Version of DaTscan™ (Ioflupane I 123 Injection) in the U.S. curiumpharma.com ↗
Curium announced today that its generic version of DaTscan (Ioflupane I 123 Injection) was approved on March 30, 2022, by the U.S. Food and Drug Administration (FDA). |
| 2021-05-04 | Curium US LLC | Regulatory Curium Announces Filing of a Generic Version of DaTscan™ (Ioflupane I 123 Injection) in the U.S. curiumpharma.com ↗
Curium announced today that it submitted an abbreviated new drug application for a generic version of DaTscan (Ioflupane I 123 Injection) with the U.S. Food and Drug Administration (FDA). |
All press releases naming this drug 4 releases
| Date | Issuer | Release |
|---|---|---|
| 2022-11-22 | Curium US LLC | Curium Announces New Indication for Ioflupane I 123 Injection in the U.S. curiumpharma.com ↗ |
| 2022-11-03 | GE Healthcare | DATSCAN™ (Ioflupane I 123 Injection) indication expanded to include use in patients with suspected Dementia with Lewy Bodies (DLB) gehealthcare.com ↗ |
| 2022-04-05 | Curium US LLC | Curium Announces FDA Approval of a Generic Version of DaTscan™ (Ioflupane I 123 Injection) in the U.S. curiumpharma.com ↗ |
| 2021-05-04 | Curium US LLC | Curium Announces Filing of a Generic Version of DaTscan™ (Ioflupane I 123 Injection) in the U.S. curiumpharma.com ↗ |
Evidence & citations 3 cited values
Every value below carries the sentence it was read from. 2 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Ioflupane | “OBJECTIVES: To pool clinical trials of similar design to assess overall sensitivity and specificity of ioflupane I123 injection (DaTSCAN or ioflupane ((123)I)) to detect or...” PMID 24993764 ↗ Jul 2014 |
| Known as | DaTSCAN | “OBJECTIVES: To pool clinical trials of similar design to assess overall sensitivity and specificity of ioflupane I123 injection (DaTSCAN or ioflupane ((123)I)) to detect or...” PMID 24993764 ↗ Jul 2014 |
| Known as | ioflupane ((123)I) | “OBJECTIVES: To pool clinical trials of similar design to assess overall sensitivity and specificity of ioflupane I123 injection (DaTSCAN or ioflupane ((123)I)) to detect or...” PMID 24993764 ↗ Jul 2014 |