Drugs / CM-AT
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed | US (FDA) | — | autism | 2013-11-04 | “Curemark LLC announced that it has begun the rolling submission of a New Drug Application (NDA) for CM-AT, the company’s autism treatment, with the U.S. Food and Drug Administration.” curemark.com ↗ |
Trials 1
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 3 | NCT02410902 | May 2015 → Dec 2017 | autism | Curemark | Completed | Met primary |
Press releases naming this drug 2 releases
| Date | Issuer | Release |
|---|---|---|
| 2013-11-04 | Curemark | Curemark Begins NDA Submission For CM-AT Autism Treatment curemark.com ↗ |
| 2013-04-23 | Curemark | Curemark LLC Announces Positive Pre-NDA Meeting With FDA for New Drug Application for CM-AT for Autism curemark.com ↗ |
Evidence & citations 2 cited values
Every value below carries the sentence it was read from. 1 source stands behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | CM-AT | ClinicalTrials.gov intervention name — accepted as the source's own label NCT02410902 ↗ |
| Modality | Protein / enzyme biologic | “CM-AT is a proprietary enzyme” NCT02410902 ↗ |