Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
intranasal oxytocin · 1 trial · 1 indication
Participants will complete a task evaluating emotional expressions. These stimuli are identical to those published previously by Leknes et al., (2012).
Participants will complete a task evaluating faces that morph into different emotional expressions.
| Arm | Type | Description |
|---|---|---|
| 8IU intranasal oxytocin | ACTIVE_COMPARATOR | 8IU intranasal oxytocin delivered with the OptiNose Breath Powered Bi directional liquid device |
| 24IU intranasal oxytocin | ACTIVE_COMPARATOR | 24IU intranasal oxytocin delivered with the OptiNose Breath Powered Bi directional liquid device |
| Placebo | PLACEBO_COMPARATOR | Placebo delivered with the OptiNose Breath Powered Bi directional liquid device |
| Name | Type | Description |
|---|---|---|
| 8IU intranasal oxytocin | DRUG | - |
| 24IU intranasal oxytocin | DRUG | - |
| Placebo | DRUG | - |
| OptiNose Breath Powered Bi | DEVICE | - |
Inclusion Criteria: * Male subjects between the ages of 18 and 35, both inclusive, with a confirmed diagnosis of autism spectrum disorder (ASD) diagnosis. * Subjects must be in good general health, as determined by the investigator. * Subject's pre-study physical examination, vital signs and electr...
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 |
Intranasal oxytocin is being studied as a treatment for Autism Spectrum Disorder in adults. It is an investigational therapy delivered into the nose, and the clinical work to date has focused on adults with this condition rather than on any approved use.
OptiNose, Inc., which trades under the ticker OPTN, is the developer of intranasal oxytocin. The company sponsored the clinical work evaluating a single intranasal dose administered with a novel device in adults with Autism Spectrum Disorder.
Intranasal oxytocin is in Phase 1 development. It is investigational and has not been approved for any indication. The Phase 1 study in adults with Autism Spectrum Disorder has been completed, and no trials of this asset are currently active.
Intranasal oxytocin has been studied in one clinical trial, NCT02414503, titled Effects of Intranasal Administration of a Single Dose of Oxytocin Using a Novel Device in Adults With Autism Spectrum Disorder. That Phase 1 trial was completed, enrolled 17 participants, and was conducted in Norway.
The Phase 1 trial NCT02414503 was randomized, double blind, and placebo controlled. It enrolled 17 adults with Autism Spectrum Disorder, was limited to male participants aged 18 years and older, did not include healthy volunteers, and was conducted in Norway.