Carbetocin (intranasal) dosage and evidence
Written by Aaron CuhaReviewed Sep 2026
The short answer
A failed drug program, and this page says so.
Evidence grade for Carbetocin (intranasal): Moderate. The rule: at least one finished study in people, and at least 100 people who took it. The sum on this page: 3 completed trials, 343 people given it. A grade counts how much has been done to people, not whether it works.
- People given it
- 343
- Human studies
- 3
- Found nothing
- 1
Dose
No human dose established
Amounts that were given in studies sit in Human evidence on this page. None of them is a personal dose.
3 completed trials, 343 people given it
No first-hand reports gathered yet. That is a gap in what we have collected, not a finding that nothing has been reported.
Goal pages: Injury, healing and recovery, Bone and joints
In plain English
In plain English, from Aaron
This is how I would explain it to a friend. The evidence, with the numbers, is further down the page.
Carbetocin nasal spray is a longer-lasting cousin of oxytocin, the bonding hormone. It was tested for the extreme hunger of Prader-Willi syndrome, a rare genetic condition. It failed. The carbetocin shot used after childbirth is a different product.
What people take it for
- Calming the constant hunger of Prader-Willi syndrome.
- Less anxiety and distress in the same condition.
- As proof that oxytocin-type drugs change behaviour, which is how it often gets cited.
What studies in people showed
The biggest study had 175 people with Prader-Willi syndrome. They used the spray or a dummy spray three times a day for 12 weeks. Hunger scores improved 4.8 points on the drug and 5.1 on the dummy. So the dummy did slightly better. An earlier study of 130 young people also missed its main goals. The company then stopped a follow-on study of 168 people. It said more dosing was not likely to help.
What people report
Reports, not study results
The good
- Most people handled it fine in the studies. Side effects were mostly mild.
The bad
- It did not ease hunger any better than a dummy spray.
- In the biggest study, 7.2 percent got headaches and 6.0 percent got a fever.
- Flushing was the most common side effect in the earlier study.
Where these come from: Everything here is from the studies on this page. We have not collected user reports on this one yet.
My bottom line
This was tested the right way, and it failed. A hopeful study title is not a result. Read what the study found, not the headline.
An opinion, not a finding. I am a coach, not a doctor.
What it has been measured to do
Measured in people
Goals Carbetocin (intranasal) has been tested for in people, biggest studies first. We count only what the studies on this page say, so the real numbers may be higher.
- Pain175 people · 1 study
35 of the 36 indexed goals have no study of any kind behind Carbetocin (intranasal)
No study in people, animals or cells on this page reports a result for these. That does not prove Carbetocin (intranasal) does nothing for them. It does mean anything you have heard about Carbetocin (intranasal) and one of these did not come from a study cited here.
Show full evidence
What is Carbetocin (intranasal)?
A failed drug program, and this page says so. Both large final-stage studies in Prader-Willi syndrome missed their main goal. In the check study, hunger scores differed by just 0.3 points between the nasal spray and a dummy spray, with the dummy slightly ahead. The company then stopped its own follow-on study because carrying on was not likely to help.
This page exists because carbetocin nasal spray is often held up as proof that oxytocin-type drugs change behaviour. The studies it is cited from failed.
Carbetocin is a lab-made cousin of oxytocin, the bonding hormone. It sticks to the oxytocin receptor more selectively and lasts longer. The nasal spray was made to treat the constant, extreme hunger of Prader-Willi syndrome, a rare genetic condition. The idea was that the oxytocin system is one of the broken circuits in that condition. Carbetocin shots given after childbirth to stop heavy bleeding are a different product, given a different way. These studies did not test them.
The program ran in stages, and each one is public.
The biggest study, COMPASS PWS (NCT06173531), was paid for by ACADIA Pharmaceuticals. It was built to confirm a hopeful result at the 3.2 mg dose from an earlier study. 175 people got carbetocin 3.2 mg three times a day (85 people) or a dummy spray (90 people) for 12 weeks. On the hunger score, people on carbetocin improved by 4.8 points and people on the dummy by 5.1 points. The gap was 0.3 points, which is nothing. The paper says carbetocin and the dummy did not differ on anything else they looked at either.
Next came an extension study (NCT06420297) where 168 people knowingly took carbetocin. The company stopped it. The registry gives its reason in the company's own words: the main study did not work, and carrying on was not likely to give a real benefit.
The earlier large study, CARE-PWS (NCT03649477), was paid for by Levo Therapeutics. It put 130 young people aged 7 to 18 on 9.6 mg, 3.2 mg or a dummy spray, three times a day, for 8 weeks. Its main goals were hunger and obsessive-compulsive symptoms on the 9.6 mg dose. In the paper's own words, those improved on paper but not by enough to count. Only the 3.2 mg group, a side question, looked better. The pandemic cut enrolment short.
The first small study (NCT01968187) had 38 people. It was paid for by Ferring Pharmaceuticals and published in 2018.
How does Carbetocin (intranasal) work?
Carbetocin does turn on the oxytocin receptor. It is more selective and lasts longer than oxytocin, which is the whole point of the molecule. What was a guess was the next step: that turning on this receptor would calm the extreme hunger of Prader-Willi syndrome. Two well-run large studies tested that guess, and it did not hold. The chemistry works. The treatment idea built on it failed.
What have studies in people found about Carbetocin (intranasal)?
Two large final-stage studies against a dummy spray, 305 people between them, plus an extension study of 168 that was stopped. The studies were well run. The answer was no.
- COMPASS PWS (NCT06173531, paid for by ACADIA): 175 people, carbetocin 3.2 mg three times a day (85 people) or a dummy spray (90 people) for 12 weeks. Hunger scores improved 4.8 points on the drug and 5.1 on the dummy, a gap of 0.3. Nothing else they measured differed either.
- Extension study (NCT06420297, ACADIA): 168 people. Stopped by the company, which said the main study had failed.
- CARE-PWS (NCT03649477, paid for by Levo): 130 young people aged 7 to 18, two doses or a dummy spray for 8 weeks. Both main goals, hunger and obsessive symptoms on 9.6 mg, moved a little but not enough to count. The pandemic cut enrolment short.
- First small study (NCT01968187, paid for by Ferring): 38 people, finished and published in 2018 as a positive result.
- Side effects were not the problem. The most common in CARE-PWS was mild to moderate flushing. In COMPASS, 7.2% of people on carbetocin had headaches and 6.0% had a fever.
What this does not tell you: Most pages on this site have weak evidence. This one is the opposite: the studies were well run, and the only question is whether the drug got a fair chance. CARE-PWS stopped enrolling early because of the pandemic, so it had fewer people than planned. The hopeful 3.2 mg result it produced was a side question in a study that had already missed its main goals, so it needed checking. COMPASS PWS was built to check it, had enough people, and came out slightly in favour of the dummy spray. Nothing in the record points to a dose, length of treatment or group of patients that was left untested and might have worked.
The state of the research
This page exists because of how these studies get cited, not because of what they found.
The CARE-PWS paper is titled 'Intranasal Carbetocin Reduces Hyperphagia, Anxiousness, and Distress in Prader-Willi Syndrome'. Hyperphagia means extreme hunger. Read only the title and you would think the drug worked. Read the results and the main goals were missed. The title describes a side result, in a dose group that was not the main test, in a study that stopped enrolling early.
That is how a failed study becomes a citation. Titles travel. Results sections do not.
Then the check study ran, which is exactly what science is supposed to do. The dummy spray came out slightly ahead. Then the company stopped its own extension study and said why in the registry: the main study failed, and more dosing was not likely to give a real benefit.
The fair summary is this. The idea that an oxytocin-type drug would ease the hunger of Prader-Willi syndrome was tested properly, and it did not hold. That is a useful result. It is not a hopeful one. Anyone using this program as proof that oxytocin-type drugs improve behaviour is citing the title of a study that missed.
A real test of thinking means a proper test of memory, attention, speed or planning. You take it before and after, and you are compared with a group who got a dummy and did not know it. None of the seven compounds in this group has ever been tested that way. Scores for tiredness, anxiety, hunger or a doctor's overall impression are not thinking tests. Neither is a hormone level. This matters because several of these compounds are sold for focus, clarity and mental energy, and the studies behind them measured none of those things. CARE-PWS also scored obsessive-compulsive symptoms as a main goal. That measures habits and urges, not thinking skill, but it is the closest thing to a thinking measure in this whole group. It failed too.
The evidence, in charts
Fig. 1a · how many people
343people, across 3 studies in people cited here
| Study | People | Share |
|---|---|---|
| Clinical Therapeutics 2026 | 175 | 51% |
| The Journal of Clinical Endocrinology and Metabolism 2023 | 130 | 38% |
| JCI Insight 2018 | 38 | 11% |
One study holds 51% of these people, so the total rests more on one study than its size suggests. Counts are the number of people each study on this page says it signed up. That includes studies that only watched people and gave nobody the compound. 1 more study in people gives no headcount and is not counted here. Studies still signing people up are left out, and only studies cited on this page are counted.
Fig. 1b · evidence mix
All 4 sources here are studies in people.
- Study in people · done in people4100%
Counted from the list of sources on this page. It counts only what we cite, so there may be more studies out there. A review counts once, however many studies it sums up.
Fig. 2 · evidence over time
The studies cover 3 different years, 2018 to 2026, counted from the list of sources on this page.
Fig. 3 · legal status at a glance
US
Not approved
UK
Not approved
AU
Not approved
CA
Not approved
Not approved in any of the four countries shown. This is what the law says, not a verdict on the science. See Legal status below for the full text and any notes.
Fig. 4 · how much does what
Nobody has tested different amounts in people
This chart would show how the effect changes as the amount goes up. For this compound, nobody has measured that in people. So we leave it empty. We will not borrow an animal chart and pretend it works the same in people.
Fig. 5 · what the molecule is
- Kind of compound
- Peptide
- Molecule weight
- Not on file
- Half-life
- Stated in words, not a numbersee the exact wording below
- Chain length
- None on file
Half-life as stated on file: Longer than oxytocin, which is the stated design rationale for using this analogue rather than oxytocin. No specific human intranasal figure is asserted here because none was resolved in this pass.
No amino acid sequence is on file for Carbetocin (intranasal), so none is drawn rather than guessed from a name.
The studies we cite
- Study in people2026Carbetocin Nasal Spray for the Treatment of Hyperphagia in Prader-Willi Syndrome: Results From the Randomized, Placebo-Controlled, Phase 3 Compass PWS Study
This was the trial that settled the question, and carbetocin failed it. 175 people with Prader-Willi syndrome used either a carbetocin nasal spray or a dummy spray, three times a day for 12 weeks. The relentless hunger that defines the condition eased by the same amount in both groups, with the dummy group very slightly ahead. Nothing else the researchers looked at came apart either. Headache and fever were the commonest complaints. Four of the ten authors work for the company that paid for it.
The decisive trial. 175 participants randomised 1:1 to carbetocin 3.2 mg three times daily (n=85) or placebo (n=90) over 12 weeks. Least squares mean change from baseline at week 12 on HQ-CT was -4.8 (SE 0.8) on carbetocin and -5.1 (SE 0.8) on placebo; treatment difference 0.3, 95% CI -1.8 to 2.4, P = 0.79. The authors state there was no separation between carbetocin and placebo for any secondary or exploratory endpoint. Most frequent treatment-emergent events on carbetocin were headache (6 participants, 7.2%) and pyrexia (5, 6.0%). The authors' own conclusion is that carbetocin nasal spray did not demonstrate efficacy compared with placebo. Four of the ten authors are employees and stakeholders of ACADIA Pharmaceuticals, the sponsor.
- Study in people2023Intranasal Carbetocin Reduces Hyperphagia, Anxiousness, and Distress in Prader-Willi Syndrome: CARE-PWS Phase 3 Trial
The trial with the encouraging title missed the two things it was built to prove. 130 young people aged 7 to 18, at 24 clinics, used one of two carbetocin doses or a dummy spray, three times daily for eight weeks. On the higher dose, hunger and obsessive symptoms moved the right way but not far enough to call it real. The lower dose looked better on several measures, which was a side question, not the one asked. The pandemic cut enrolment short. Several authors work for the sponsor.
The trial the optimistic title comes from, and the one that did not meet its primary endpoints. 130 participants aged 7 to 18 at 24 ambulatory clinics, randomised to 9.6 mg, 3.2 mg or placebo three times daily over an 8-week placebo-controlled period. Primary endpoints were HQ-CT hyperphagia and CY-BOCS obsessive-compulsive symptoms for 9.6 mg against placebo, and in the paper's own words they showed numeric improvements which were not statistically significant. The 3.2 mg arm showed nominally significant improvements on HQ-CT, PADQ and CGI-C, a secondary comparison. Enrolment was stopped prematurely because of the COVID-19 pandemic. Most common adverse event was mild to moderate flushing. Several authors are employees of Levo Therapeutics, the sponsor.
- Study in people2018Intranasal carbetocin reduces hyperphagia in individuals with Prader-Willi syndrome
The small study that launched the whole carbetocin programme looked positive, and it did not hold up. 38 people took part in a controlled trial paid for by Ferring, and it reported less hunger. Two later and much larger trials then failed to repeat it. That pattern, a promising small study followed by bigger ones that cannot reproduce it, is the most common story in this database.
The phase 2 study that launched the programme, a randomised controlled trial in 38 participants sponsored by Ferring Pharmaceuticals, registered as NCT01968187 and listed as COMPLETED. Its positive result is the origin of the whole development path, and it did not survive replication at phase 3 twice.
- Study in people2026OLE Study of Carbetocin Nasal Spray for the Treatment of Hyperphagia in Prader-Willi Syndrome
The company stopped its own follow-on study, which tells you what it had concluded. 168 people had entered an extension in which everybody knowingly received carbetocin. The registry gives the reason in the sponsor's own words: the main trial did not work, and carrying on was not thought likely to help anyone. A company ending a study of its own product is about as plain a verdict as this record ever offers.
The open-label extension, 168 participants actual, status TERMINATED. Sponsor ACADIA Pharmaceuticals. The registry's whyStopped field, verbatim: primary efficacy endpoint was not met in the parent study (ACP-101-302), and based on review of available data, continued administration of investigational product in ACP-101-303 was not considered likely to provide significant clinical benefit. A sponsor stopping its own extension study is the clearest statement available about what the programme found.
Where to buy Carbetocin (intranasal)
No seller we track lists Carbetocin (intranasal) yet. We read sellers’ public product lists every week, and this section fills in as soon as one does. Every seller, graded
Common questions
Has Carbetocin (intranasal) been tested in people?
Yes. 343 people given it across 3 completed trials cited here, 1 of which found nothing. A failed drug program, and this page says so.
What is the Carbetocin (intranasal) dosage?
No human dose established. Amounts that were given in studies sit in Human evidence on this page. None of them is a personal dose. 3 completed trials, 343 people given it
Is Carbetocin (intranasal) FDA-approved?
Not approved. A search of the FDA's public drug-label database for carbetocin finds nothing, which fits with there being no approved US product. The final-stage follow-up study failed and the extension study was stopped. So the nasal spray version has no active path to approval.
Did intranasal carbetocin work for Prader-Willi syndrome?
No. Both large final-stage studies missed their main goal. The check study, COMPASS PWS, gave 175 people either carbetocin 3.2 mg three times a day or a dummy spray for 12 weeks. Hunger scores differed by 0.3 points, which is nothing, and nothing else they measured differed either. The company then stopped its follow-on study.
Why do people cite the CARE-PWS trial as positive?
Because of its title, which says carbetocin reduces hunger, anxiousness and distress. The results say the main goals were missed. The upbeat finding was a side result in the 3.2 mg group of a study that stopped enrolling early because of the pandemic. The study built to confirm it did not confirm it.
Is this the same as the carbetocin used in childbirth?
No. Carbetocin shots to prevent heavy bleeding after childbirth are a separate product, given a different way for a different reason, and approved in several countries. None of the Prader-Willi results apply to it. None of its approvals apply to the nasal spray.
Was it unsafe?
Side effects were not the issue. The most common one in CARE-PWS was mild to moderate flushing. In COMPASS, the most common on carbetocin were headache in 7.2% and fever in 6.0%. People handled the drug fine. It just did not work.
Is intranasal carbetocin still in development?
Not for this use. The check study failed, and the company stopped its extension study. It wrote in the registry that more dosing was not likely to give a real benefit.