Claimed effect · Oxytocin (intranasal)

Does Oxytocin (intranasal) help with social function in autism?

B
Grade B — probable, not settled1 large phase 2 RCT (n=290) · effect size: not measurable
Short answerProbable, not settled. Human data exist (1 large phase 2 RCT (n=290)) and mostly agree, showing no measurable effect, or none yet shown — but too few, too small, or not yet peer-reviewed for a firm answer. SOARS-B, the definitive 24-week trial in children and adolescents, found no difference from placebo on its primary social-withdrawal measure or on secondary outcomes.

What the studies show

SOARS-B, the definitive 24-week trial in children and adolescents, found no difference from placebo on its primary social-withdrawal measure or on secondary outcomes.

“The least-squares mean change from baseline in the ABC-mSW score (primary outcome) was -3.7 in the oxytocin group and -3.5 in the placebo group (least-squares mean difference, -0.2; 95% confidence interval, -1.5 to 1.0; P = 0.61).”

Verbatim, from the abstractSikich L, et al. Intranasal oxytocin in children and adolescents with autism spectrum disorder (SOARS-B). N Engl J Med, 2021;385:1462–1473

Human trials exist and mostly agree, but there are too few of them, they are too small, or one big one is still reading out. Expect the grade to move.

  1. 1
    Sikich L, et al. Intranasal oxytocin in children and adolescents with autism spectrum disorder (SOARS-B).N Engl J Med, 2021;385:1462–1473290 participants, 24 weeks; primary and secondary outcomes null.

In context

Oxytocin is a natural nine-amino-acid hormone, licensed for decades as an injection to induce labour and control bleeding. The compound sold and discussed in the peptide world is intranasal oxytocin, promoted for bonding, appetite and social behaviour. Here the evidence is largely negative: the largest randomised trial in autism found no benefit, and a randomised obesity trial found no weight loss. It is well tolerated, but the popular claims rest on small early studies that the big trials did not confirm.

Oxytocin (intranasal) is approved (rx) as injection; intranasal use unlicensed. Legal status differs by country — see the regulation section or the jurisdiction pages.

Questions

Is Oxytocin (intranasal) proven to help with social function in autism?
Not yet settled. 1 large phase 2 RCT (n=290) — LYO grades it B, meaning probable but liable to change as trials read out.
What studies are behind the grade?
SOARS-B, the definitive 24-week trial in children and adolescents, found no difference from placebo on its primary social-withdrawal measure or on secondary outcomes.
Is Oxytocin (intranasal) approved for this?
Oxytocin (intranasal) is an approved medicine (Approved (Rx) as injection; intranasal use unlicensed); whether this particular outcome is a licensed indication is stated on the compound page's regulation section.

Other outcomes for Oxytocin (intranasal)

Written and maintained by LYO Research — how pages are written and checked. Reviewed 3 September 2026. Grades count human evidence only; see how LYO grades. Not medical advice. Correct this page →