Drugs / AMZ002
Trials 1
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 3 | NCT05128344 | Apr 2023 → Jun 2025 | infantile spasms | Amzell | Withdrawn | No outcome recorded Stop: Business |
News releases announcing trial results or a regulatory action · 1
| Date | Issuer | Release |
|---|---|---|
| 2021-10-11 | Amzell | Regulatory AMZELL BV receives FDA Special Protocol Assessment for Phase 3 trial of innovative injectable treatment for infantile epileptic disease amzell.com ↗
Specialist development pharmaceutical company AMZELL B.V. and the FDA have reached an agreement on the protocol for the Phase 3 trial of its infantile epileptic disease therapy under an FDA Special Protocol Assessment (SPA). |
All press releases naming this drug 1 release
| Date | Issuer | Release |
|---|---|---|
| 2021-10-11 | Amzell | AMZELL BV receives FDA Special Protocol Assessment for Phase 3 trial of innovative injectable treatment for infantile epileptic disease amzell.com ↗ |
Evidence & citations 1 cited value
Every value below carries the sentence it was read from. 1 source stands behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | AMZ002 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT05128344 ↗ |