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Also known as 1. Intranasal oxytocin spray
1. Intranasal oxytocin · 1 trial · 2 indications
| Arm | Type | Description |
|---|---|---|
| 1. Intranasal Oxytocin | EXPERIMENTAL | Intranasal oxytocin spray (30 IU twice daily) for 12 months in the double-blinded phase followed by intranasal oxytocin spray (30 IU twice daily) for 6-months in the open-label phase |
| 2. Placebo | PLACEBO_COMPARATOR | Intranasal placebo spray (30 IU twice daily (total 60 IU per day) for 12 months followed by intranasal oxytocin spray (30 IU twice daily) for 6-months in the open-label phase |
| Name | Type | Description |
|---|---|---|
| 1. Intranasal oxytocin spray | DRUG | 30 IU, twice daily for 12 months in the experimental arm in double-blinded phase |
| 2. Intranasal placebo spray | DRUG | 30 IU, twice daily for 12 months in the placebo comparator arm in double-blinded phase |
| 3. Intranasal Oxytocin spray | DRUG | 30 IU, twice daily for 6 months in both experimental and placebo comparator arm in open-label phase |
Inclusion Criteria: 1. Ages 6 to 18 years old at Randomization 2. BMI greater than or equal to the 5th percentile 3. Expert clinical diagnosis of ASD 4. Availability of parent/guardian to provide informed consent Exclusion Criteria: 1. Fragile X, tuberous sclerosis, William's syndrome, Angelman's...
Intranasal oxytocin is an investigational small molecule being studied for Autism Spectrum Disorder, specifically for its effects on bone health in children with the condition. It is administered as a nasal spray and is currently in Phase 2 clinical development.
Intranasal oxytocin targets the oxytocin receptor, a G protein-coupled receptor involved in social behavior and bone metabolism. By activating this receptor, the drug is hypothesized to influence bone health in children with Autism Spectrum Disorder, though its exact mechanism in this context is still under investigation.
Intranasal oxytocin is being developed by United Therapeutics Corporation, a publicly traded biopharmaceutical company listed on NASDAQ under the ticker symbol UTHR. The company is conducting clinical trials to evaluate the drug's safety and efficacy in Autism Spectrum Disorder.
Intranasal oxytocin is in Phase 2 clinical development. It is an investigational drug and has not been approved by the FDA. The ongoing Phase 2 trial is recruiting participants to study its effects on bone health in children with Autism Spectrum Disorder.
Intranasal oxytocin is being studied in a single Phase 2 clinical trial with the identifier NCT05754073, titled 'Oxytocin Effects on Bone in Children With Autism Spectrum Disorder.' This randomized, double-blind, placebo-controlled trial is recruiting 96 participants aged 6 years and older in the United States.
Yes, intranasal oxytocin is also known as intranasal oxytocin spray. Both names refer to the same investigational drug being developed by United Therapeutics Corporation for Autism Spectrum Disorder. The drug is administered via nasal spray and is currently in Phase 2 clinical trials.