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 | “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 | NCT02649959 | Oct 2015 → Jan 2028 expected | autism | Curemark | Active not recruiting | Met primary |
News releases announcing trial results or a regulatory action · 2
| Date | Issuer | Release |
|---|---|---|
| 2019-05-06 | Curemark | Results Curemark Presents Preschool Population Data from Phase 3 Blüm Autism Study curemark.com ↗
Our data suggests that CM-AT has an effect on core and non-core symptoms, including communication, in children ages 3 through to 6 with autism. |
| 2013-11-04 | Curemark | Regulatory Curemark Begins NDA Submission For CM-AT Autism Treatment curemark.com ↗
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. |
All press releases naming this drug 3 releases
| Date | Issuer | Release |
|---|---|---|
| 2019-05-06 | Curemark | Curemark Presents Preschool Population Data from Phase 3 Blüm Autism Study curemark.com ↗ |
| 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 NCT02649959 ↗ |
| Modality | Protein / enzyme biologic | “CM-AT is a proprietary enzyme” NCT02649959 ↗ |