Oxytocin is a nine-amino-acid peptide hormone made in the hypothalamus. As a drug, the US uses it one way: an intravenous or intramuscular injection in labour (Pitocin and generics). The demand behind "oxytocin nasal spray" is about everything else — social behaviour, autism, appetite, mood — and all of that rests on research trials of a nasal formulation with no marketed US product.
This page reports that research record condition by condition. Two related questions live elsewhere: what it does to the body and how safe it was in trials is on our oxytocin side effects page, and the units, doses and label figures are on oxytocin dosage. Medibact Guides works through the arithmetic in its oxytocin dosage guide, and Peptide Lexicon has the molecule in its oxytocin entry. Nothing here is a recommendation; any use outside a trial is a question for a clinician.
There was a US nasal product, and it is discontinued
Drugs@FDA, read 3 November 2026, lists oxytocin under nine applications. One is nasal: Syntocinon nasal solution, 40 USP units per mL, NDA 012285, marketing status Discontinued. The others are injections — Pitocin (NDA 018261) and generic oxytocin from Hikma, Fresenius Kabi and Sagent marketed; older injection applications from Abbott, Novartis and Dr. Reddy's discontinued.
So "no US nasal oxytocin" is true of the market today, not of the regulatory history. Drugs@FDA does not carry a submission record for that application, so the dates it was approved and withdrawn are not stated in the record we read. What the record does establish: a nasal spray sold in the US now is not the discontinued Syntocinon product and has no current FDA approval.
What the registry holds
ClinicalTrials.gov, queried for "intranasal oxytocin" on 3 November 2026:
| Status | Studies |
|---|---|
| Completed | 200 |
| Recruiting | 22 |
| Terminated | 20 |
| Unknown | 34 |
| Withdrawn | 9 |
| Not yet recruiting / active / other | 7 |
| Total | 292 |
| With results posted | 96 |
Leading first-listed conditions: healthy volunteers 51, schizophrenia 21, autism 28 (spread across "autism spectrum disorder", "autism spectrum disorders" and "autism"), Prader-Willi syndrome 9, alcohol use disorder 9, pain 6, PTSD 4, frontotemporal dementia 4, obesity 4. Healthy volunteers lead because most oxytocin research is a single dose in a laboratory task — the kind of study behind the "trust hormone" headlines, which measures a behaviour in the hour after a spray, not a treatment.
PubMed returned 864 records with "intranasal oxytocin" in the title or abstract on the same date.
Autism: the largest trial was null
| Trial | Who | Regimen | Main result |
|---|---|---|---|
| SOARS-B (Sikich et al., NEJM 2021; NCT01944046) | 290 children and adolescents, 3–17 | Target 48 IU daily, 24 weeks, vs placebo | Social withdrawal −3.7 vs −3.5 (difference −0.2, 95% CI −1.5 to 1.0; P = 0.61); secondary outcomes generally no different |
SOARS-B was funded by the US National Institute of Child Health and Human Development and is the largest and longest autism trial of the spray. Its introduction notes that oxytocin "has been administered in clinical practice to many children with autism" — which is the reason a trial this size was run, and why its null result is the reference point. Adverse events were similar in incidence and severity in both groups.
Smaller trials since (a 2023 Belgian multiple-dose trial in children, 2023–2024 imaging studies, and a 2026 study of the placebo response in an ongoing trial) continue to report mixed or secondary-measure findings. None has replaced SOARS-B as the largest test of the main question.
Obesity: no weight change
| Trial | Who | Regimen | Result |
|---|---|---|---|
| Plessow et al., NEJM Evidence 2024 (NCT03043053) | 61 adults with obesity, mean BMI 36.9 | 24 IU four times daily, 8 weeks, vs placebo | Weight +0.20 vs +0.26 kg (P = 0.934); no benefit on total fat, visceral fat, liver fat or resting energy expenditure |
The single positive signal was a lower intake at a laboratory test meal: −31.4 kcal against +120.6 kcal on placebo, a difference of 152 kcal (95% CI −302.3 to −1.7). That is one meal in a laboratory, not a change in eating over eight weeks, and body weight did not follow it. A separate 2026 trial of oxytocin given intravenously found no effect on food intake or post-meal glucose in adults with obesity.
Prader-Willi syndrome: small and mixed
People with Prader-Willi syndrome have fewer oxytocin-producing neurons in the hypothalamus, which is why the hormone was tested for the syndrome's extreme hunger.
| Trial | Who | Result |
|---|---|---|
| Miller et al., Am J Med Genet A 2017 | 24 children, crossover, 5 days of each | Every scale favoured oxytocin; no single measure reached significance; effect diminished by day 14 |
| Hollander et al., J Psychiatr Res 2021 (pilot) | Children with PWS | Placebo associated with modest improvement in hyperphagia and repetitive behaviour; oxytocin not |
Oxytocin's related molecule carbetocin was taken further in Prader-Willi syndrome as its own drug programme; it is a different peptide and its results are not oxytocin's.
Across mental disorders: the 2026 meta-analysis
Bonnieux et al. (Neuroscience & Biobehavioral Reviews, August 2026) pooled 42 double-blind randomised trials, 1,922 participants, comparing symptoms on intranasal oxytocin and placebo:
| Analysis | Effect size (g) | 95% CI |
|---|---|---|
| All disorders | 0.17 | −0.05 to 0.38 (not significant; I² 77.4%) |
| Two outlier substance-use trials removed | 0.05 | −0.03 to 0.12 |
| Schizophrenia-spectrum disorders | 0.12 | 0.01 to 0.23 (significant) |
The authors found no moderation by dose, number of doses or age, and reported that trials with more women showed larger effects — while noting that women are under-represented. An effect size of 0.12 is small by any convention.
What the record does not establish
- A dose that works for anything. The trials above used 48 IU a day (SOARS-B) and 96 IU a day (the obesity trial), and the registry holds single sprays from under 1 IU upward; our dosage page tabulates them. None of the trials above established a benefit on its main outcome.
- Long-term use. The longest large trial is SOARS-B at 24 weeks.
- The quality of non-trial products. None is FDA-approved; trial results describe trial supply.
Oxytocin also appears on our FDA-approved peptides census as an injection.
Sources
- Drugs@FDA via openFDA, oxytocin applications (NDA 012285 Syntocinon nasal, NDA 018261 Pitocin, and others), data updated 30 October 2026, read 3 November 2026.
- ClinicalTrials.gov API v2, query
intranasal oxytocin, 292 studies, read 3 November 2026. - PubMed E-utilities,
intranasal oxytocin[tiab](864 records) and the trial searches named above, read 3 November 2026. - Sikich L et al. Intranasal oxytocin in children and adolescents with autism spectrum disorder. N Engl J Med 2021;385:1462–1473. doi:10.1056/NEJMoa2103583. PMID 34644471.
- Plessow F et al. Intranasal oxytocin for obesity. NEJM Evidence 2024. doi:10.1056/EVIDoa2300349. PMID 38815173.
- Miller JL et al. Oxytocin treatment in children with Prader-Willi syndrome: a double-blind, placebo-controlled, crossover study. Am J Med Genet A 2017. doi:10.1002/ajmg.a.38160. PMID 28371242.
- Hollander E et al. Intranasal oxytocin versus placebo for hyperphagia and repetitive behaviors in children with Prader-Willi syndrome. J Psychiatr Res 2021. doi:10.1016/j.jpsychires.2020.11.006. PMID 33190843.
- Bonnieux J et al. Does intranasal oxytocin reduce symptoms of mental disorders? A meta-analysis of clinical trials. Neurosci Biobehav Rev 2026. doi:10.1016/j.neubiorev.2026.106749. PMID 42134427.
- Gether IM et al. Intravenous oxytocin has no effect on ad libitum food intake or postprandial plasma glucose concentrations in individuals with obesity. Diabetes Obes Metab 2026. PMID 41804830.