FDA-approved in another form
Oxytocin has been tested more than almost anything sold as a supplement, and the biggest trials came back empty
Most compounds in this market have no human evidence. Oxytocin has hundreds of trials, which is why its record is so readable. The 290-child autism trial, the 8-week obesity trial and two preregistered replications of the famous trust study all failed to beat placebo, and measured nasal bioavailability is 0.7%. Every row below states its trial, its endpoint and its result.
- 43primary studies and reviews in our graded evidence table
- 41of them human evidence, not animal extrapolation
- 12of the 21 randomized human trials here reported no benefit on their own primary endpoint
- 65fetch-verified citations, 100.0% peer-reviewed, government or trial registry
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Key facts
- StatusFDA-approved in another form
- Between-person variability47% median model inaccuracy intranasal vs 18% intravenous
- Plasma peak after 24 IU nasal15 minutes, declining by 75 minutes
- Cerebrospinal fluid after 24 IU nasalRises, but takes up to 75 minutes to reach significance
- Plasma to CSF correlationNone detected (r below 0.10)
- Amygdala perfusion effectExplained entirely by the systemic rise, after nasal and intravenous dosing alike
- Nasal versus intravenous for CSFNo intranasal advantage in labelled-oxytocin primate work
- Central release of endogenous oxytocinNot observed after peripheral dosing in primates
- Dose-response in brain perfusionLarger amygdala effects at lower doses (9 to 36 IU tested)
- Assay problemAntibody assays read systematically lower than mass spectrometry; older oxytocin measurements are contested
- Human oral bioavailabilityNot applicable; oxytocin is a peptide degraded in the gut and no oral product exists
- ClassCyclic nonapeptide hormone; oxytocin-receptor agonist
- SequenceCys-Tyr-Ile-Gln-Asn-Cys-Pro-Leu-Gly-NH2 (1-6 disulfide)
- Molecular weight1007.19 Da (C43H66N12O12S2)
- CAS number50-56-6
- FDA-approved formInjection only (Pitocin, NDA 018261, 10 USP units/mL)
- Approved indicationsInduction or stimulation of labor with a medical indication, adjunct in incomplete or inevitable abortion, and control of postpartum bleeding
- Nasal form statusNo FDA-approved nasal product; Syntocinon nasal solution (40 USP units/mL) is Discontinued
- Why the nasal spray left the marketApproval withdrawn in 1997 at the sponsor's request after the product was no longer marketed, not on a safety or effectiveness finding
- Plasma half-lifeAbout 1 to 6 minutes (FDA label; shorter in late pregnancy and lactation)
- Intranasal bioavailability0.7% by mass spectrometry, with 47% median model inaccuracy between people
- Standard research spray dose4 IU per actuation; 24 IU is three actuations per nostril
- Largest autism trial resultNo benefit over placebo at 48 IU/day for 24 weeks in 290 children and adolescents
- Largest obesity trial resultNo weight change over placebo at 96 IU/day for 8 weeks in 61 adults with obesity
- Human trials in this table41 of 43 rows are human evidence
Browse by topic
Everything on Oxytocin, organized the way you research it.
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Practical calculators and references, each scoped and sourced.
study rows by species, from the evidence table
All guides
63 in-depth, individually cited guides.
Evidence 26 guides
Safety 19 guides
Sourcing 8 guides
Dosing 6 guides
Comparisons 4 guides
We will tell you if the evidence ever changes
One short email when something real happens: a new randomized trial, a replication, an FDA action on nasal oxytocin. Care options are presented separately from this email brief.