Drugs / AstroRx
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed | US (FDA) | AstroRx® | amyotrophic lateral sclerosis 28 | 2023-02-19 | “has submitted an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA)” kadimastem.com ↗ |
Trials 1
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 1/2 | NCT03482050 | Apr 2018 → Jun 2020 | amyotrophic lateral sclerosis | Kadimastem | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 3
| Date | Issuer | Release |
|---|---|---|
| 2023-02-19 | Kadimastem | Regulatory Kadimastem Submits IND Application to the FDA for its Phase IIa Clinical Trial with AstroRx® for ALS kadimastem.com ↗ |
| 2023-02-15 | Kadimastem | Results Kadimastem kadimastem.com ↗ |
| 2023-02-05 | Kadimastem | Regulatory Awarded Patent in Australia for its AstroRx® Technology for the Treatment of ALS and Drug Screening kadimastem.com ↗ |
All press releases naming this drug 4 releases
| Date | Issuer | Release |
|---|---|---|
| 2023-02-19 | Kadimastem | Kadimastem Submits IND Application to the FDA for its Phase IIa Clinical Trial with AstroRx® for ALS kadimastem.com ↗ |
| 2023-02-15 | Kadimastem | Kadimastem kadimastem.com ↗ |
| 2023-02-05 | Kadimastem | Awarded Patent in Australia for its AstroRx® Technology for the Treatment of ALS and Drug Screening kadimastem.com ↗ |
| 2022-05-30 | Kadimastem | Kadimastem Awarded Patent in Japan for AstroRx® For ALS and Drug Screening kadimastem.com ↗ |
Evidence & citations 2 cited values
Every value below carries the sentence it was read from. 2 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | AstroRx | ClinicalTrials.gov intervention name — accepted as the source's own label NCT03482050 ↗ |
| Modality | Cell therapy | “AstroRx® is an allogeneic cell-based product” PMID 36788520 ↗ Feb 2023 |