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DT402 · 1 trial · 2 indications
The NRS is an 11-point PRO scale used to measure the severity or intensity of effects from 0 (no effect) to 10 (high severity or intensity of effect). It consists of various items related to both positive and negative effects in the autism patient population.
| Arm | Type | Description |
|---|---|---|
| 200 mg DT402 | EXPERIMENTAL | A psychoactive substance that mediates effects mainly through a release of the monoaminergic neurotransmitters, with the greatest effect on 5-HT, followed by NE and DA |
| Name | Type | Description |
|---|---|---|
| DT402 (R-enantiomer of 3,4-methylenedioxymethamphetamine (MDMA)) | DRUG | A psychoactive substance that mediates effects mainly through a release of the monoaminergic neurotransmitters, with the greatest effect on 5-HT, followed by NE and DA |
Inclusion Criteria: 1. Diagnosis of ASD per records as confirmed by standard semi-structured interview for Autism diagnosis (eg, Autism Diagnostic Observation Schedule-Second Edition) 2. Male or Female aged 18 to 65 3. Presents with clinically significant deficits in socialization and communication...
Top 3 of 4 competitors
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Bristol-Myers Squibb Company | BMY | 3 | PHASE3 | Xanomeline and trospium chloride, KarX-EC |
| Definium Therapeutics, Inc. | DFTX | 1 | PHASE2 | DT402 |
| MapLight Therapeutics, Inc. | MPLT | 1 | PHASE2 | ML-004 |
DT402 is an investigational small molecule being developed by Definium Therapeutics, Inc. for Autism Spectrum Disorder. It is the R-enantiomer of 3,4-methylenedioxymethamphetamine, also known as MDMA. DT402 is currently in Phase 2 clinical development and has not been approved by the FDA.
DT402 is being studied for the treatment of Autism Spectrum Disorder in adults. The only registered trial of DT402 enrolls adults aged 18 years and older with Autism Spectrum Disorder, also referred to as ASD. It is investigational and has not been approved for any use.
DT402 targets serotonin. It is the R-enantiomer of 3,4-methylenedioxymethamphetamine, a small molecule whose activity involves the serotonin system. Definium Therapeutics is developing DT402 as a serotonin-targeted investigational therapy for Autism Spectrum Disorder.
Definium Therapeutics, Inc. is developing DT402. The company trades under the ticker DFTX. Definium Therapeutics is the sponsor of the Phase 2A trial of DT402 in Autism Spectrum Disorder, which is currently recruiting participants in the United States.
DT402 is in Phase 2 development. Its single registered trial is a Phase 2A study in Autism Spectrum Disorder that is currently recruiting. DT402 is investigational and has not been approved by the FDA for any indication.
DT402 is being studied in one clinical trial, NCT07303907, titled A Phase 2A Trial of DT402 for Autism Spectrum Disorder. The trial is recruiting 20 participants in the United States, enrolls adults aged 18 years and older of all sexes, and is uncontrolled, meaning it is not randomized and not double blinded.
DT402 is the R-enantiomer of 3,4-methylenedioxymethamphetamine, which is commonly known as MDMA. Because it is a single enantiomer rather than the racemic mixture, DT402 is a distinct chemical entity being developed separately by Definium Therapeutics for Autism Spectrum Disorder.