Drugs / ioflupane 123I
ioflupane 123I
Regulatory milestones approvals, filings & regulatory actions · 3 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Label expansion | US (FDA) | DATSCAN | — | 2022-11-01 | fda.gov ↗ |
| Approved | US (FDA) | DATSCAN | — | 2011-01-14 | fda.gov ↗ |
| Approved | EU (EMA) | DaTSCAN | — | 2000-07-27 | europa.eu ↗ |
Trials 4
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 22 trials | ||||||
| Phase 2 | NCT03185182 | Jul 2017 → Sep 2018 | clear cell renal carcinoma | Region Skane | Terminated | No outcome recorded |
| Phase 2 | NCT00940914 | Mar 2009 → Mar 2010 | Parkinson disease | University Hospital, Toulouse | Completed | No outcome recorded |
| Phase 32 trials | ||||||
| Phase 3 | NCT04193527 | Jun 2020 → Dec 2021 | Parkinson disease, essential tremor, multiple system atrophy, progressive supranuclear palsy | GE Healthcare | Completed | No outcome recorded |
| Phase 3 | NCT01160263 | Oct 2012 → Oct 2014 | amyotrophic lateral sclerosis | Assistance Publique - Hôpitaux de Paris | Completed | No outcome recorded |
| Comparator or background therapy1 trial | ||||||
| Phase 3 | NCT01950468 Comparator | Apr 2017 → Mar 2018 | parkinsonian disorder | Navidea Biopharmaceuticals | Withdrawn | No outcome recorded |
News releases announcing trial results or a regulatory action · 1
| 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). |
All press releases naming this drug 1 release
| Date | Issuer | Release |
|---|---|---|
| 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 ↗ |
Evidence & citations 6 cited values
Every value below carries the sentence it was read from. 5 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Ioflupane (123I) | ClinicalTrials.gov intervention name — accepted as the source's own label NCT04193527 ↗ |
| Known as | 123 I-FP-CIT | ClinicalTrials.gov intervention name — accepted as the source's own label NCT01160263 ↗ |
| Known as | DATSCAN | “123 I-FP-CIT (DATSCAN) : 185 MBq (5 mCi), 2,5 ml will be injected via an arm intravenous catheter.” NCT01160263 ↗ |
| Known as | Ioflupane I123 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT03185182 ↗ |
| Modality | Diagnostic / imaging agent | “By analyzing the focal uptake of Ioflupane (123I) with SPECT / CT the progression of the disease may be clarified.” NCT03185182 ↗ |
| Route | Intravenous | “IV (in the vein)” NCT00940914 ↗ |