PeptideTrace
ApprovedNeurohypophyseal Hormone

Oxytocin

Pitocin

A

Evidence Grade A — Regulatory approved. 28829 published studies. 811 registered clinical trials.

811 trials28,829 studiesUSEUCA

Licensed Indications

  • Labor Induction
  • Postpartum Hemorrhage

User Experience Reports

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Overview

Oxytocin (sold as Pitocin) is a synthetic version of the naturally occurring "love hormone" — produced in the brain and involved in childbirth, breastfeeding, and social bonding. In hospitals, it is one of the most commonly used medications in obstetrics: given intravenously to induce or strengthen labour contractions and to prevent dangerous bleeding after delivery. It is on the WHO's List of Essential Medicines.

Research Activity

28,829studies
Human 13927
Animal 11544
In-vitro 2044
Reviews 3907

28,829 published studies: 13927 human, 11544 animal, 2044 in-vitro, 3907 reviews

Regulatory Status

US
FDA-approved(FDA)
EU
Not authorised by EMA(EMA)
CA
Health Canada approved(Health Canada)

Legal Status

USPrescription drug (Rx)
EUNot applicable (not authorised)
CAPrescription drug

Summary

Oxytocin (as Pitocin) is used worldwide for labour induction, labour augmentation, and prevention of postpartum haemorrhage. It requires careful intravenous dose titration because excessive stimulation can cause dangerously strong contractions.

Beyond obstetrics, oxytocin has been the subject of extensive research into its behavioural and psychological effects, including studies in autism spectrum disorder, anxiety, post-traumatic stress disorder, and social cognition. However, intranasal oxytocin for behavioural applications remains experimental, and results from clinical trials have been mixed. The WHO lists injectable oxytocin as an essential medicine, and its availability and proper storage (requiring refrigeration) are significant public health concerns in low-resource settings.

Mechanism of Action

Oxytocin targets specific receptors on the smooth muscle of the uterus, triggering powerful rhythmic contractions. During pregnancy, the number of these receptors increases dramatically (up to 300-fold by term), which is why the uterus becomes increasingly sensitive to oxytocin as pregnancy progresses. Oxytocin also acts on muscle cells in the breast to trigger the 'let-down' reflex during breastfeeding. Beyond these reproductive roles, oxytocin acts in the brain to influence social bonding, trust, and emotional responses, earning it the popular label of the 'love hormone.'

Research Summary

Oxytocin's role in obstetric practice is well established with decades of clinical experience. The WHO recommends it as the preferred drug for preventing postpartum haemorrhage — the leading cause of maternal death worldwide. Safe use requires careful dose titration because excessive stimulation can cause dangerously strong contractions. Beyond obstetrics, there has been extensive research into intranasal oxytocin for behavioural and neuropsychiatric conditions — autism, social anxiety, PTSD, and trust-related disorders. Results have been largely disappointing: a major 2021 trial for autism was negative, and meta-analyses show no consistent benefit. Safety concerns with high doses include water retention and dangerously low sodium levels (due to structural similarity to vasopressin). Proper storage requiring refrigeration remains a significant public health challenge in low-resource settings where postpartum haemorrhage is most common.

Clinical Trials

NCT00528255Phase IIWithdrawn

Pharmacokinetics and Safety of the 100 Mcg Misoprostol Vaginal Insert (MVI 100)

Ferring PharmaceuticalsEndpoint: The levels of misoprostol acid in plasma at time points 0 (baseline), 2, 4, 6, 8, 10 and 14 hours. Not all patients will have all in situ time points as the insert may be removed earlier for safety or efficacy reasons.
NCT01487278N/AWithdrawn

Comparing Misoprostol and Oxytocin in UnijectTM for Postpartum Hemorrhage (PPH) Prevention in Mali

Gynuity Health ProjectsEndpoint: Mean change in hemoglobin
NCT07492186N/ANot Yet Recruiting

3-hour Versus 12-hour Double-balloon Catheter for Labor Induction

Centre Hospitalier de PAUEndpoint: induction-to-birth interval reductionCompletion: 2027-03-15
NCT06713473N/ANot Yet Recruiting

Reducing Self-Dehumanization to Examine Oxytocin and Suicide Risk

Florida State UniversityEndpoint: Change in Suicidal IdeationCompletion: 2028-08-01
NCT07507266N/ANot Yet Recruiting

Emotions From Salivary Biomarkers in an Architectural Context

Sys2DiagEndpoint: Evaluate the variation of salivary biomarkers, which may be linked to emotions (positive or negative), before and after interaction with an architectural work.Completion: 2028-06-14
View all 811 trials on ClinicalTrials.gov →

Regulatory Timeline

1980
Regulatory

FDA ORIG 1

1980
Regulatory

FDA ORIG 1

1982
Regulatory

FDA SUPPL 7

1982
Regulatory

FDA SUPPL 9

1983
Regulatory

FDA SUPPL 8

1983
Regulatory

FDA SUPPL 11

1983
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FDA SUPPL 12

1984
Regulatory

FDA SUPPL 1

1984
Regulatory

FDA SUPPL 13

1985
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FDA SUPPL 14

1986
Regulatory

FDA SUPPL 2

1986
Regulatory

FDA SUPPL 16

1986
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FDA SUPPL 15

1987
Regulatory

FDA SUPPL 3

1987
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FDA SUPPL 17

1988
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FDA SUPPL 4

1988
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FDA SUPPL 18

1990
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FDA SUPPL 5

1994
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FDA SUPPL 8

1994
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FDA SUPPL 6

1994
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FDA SUPPL 7

1994
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FDA SUPPL 23

1994
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FDA SUPPL 20

1995
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FDA SUPPL 22

1996
Regulatory

FDA SUPPL 9

1996
Regulatory

Health Canada Market Authorisation

1997
Regulatory

FDA SUPPL 12

1997
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FDA SUPPL 11

1997
Regulatory

FDA SUPPL 24

1999
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FDA SUPPL 19

1999
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FDA SUPPL 13

1999
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FDA SUPPL 26

1999
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FDA SUPPL 25

1999
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FDA SUPPL 14

2000
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FDA SUPPL 15

2000
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FDA SUPPL 16

2000
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FDA SUPPL 27

2000
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FDA SUPPL 28

2000
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FDA SUPPL 17

2001
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FDA SUPPL 20

2001
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FDA SUPPL 19

2001
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FDA SUPPL 18

2001
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FDA SUPPL 22

2002
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FDA SUPPL 21

2003
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FDA SUPPL 23

2007
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FDA SUPPL 28

2007
Regulatory

FDA SUPPL 34

2013
Regulatory

FDA ORIG 1

2014
Regulatory

FDA SUPPL 32

2014
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FDA SUPPL 42

2014
Regulatory

FDA SUPPL 31

2016
Regulatory

FDA SUPPL 33

2021
Regulatory

FDA SUPPL 41

2022
Regulatory

FDA SUPPL 49

Related Compounds

Histrelin

Approved
GnRH Agonist

Histrelin is available as Supprelin LA for central precocious puberty (approved 2007). The Vantas implant for prostate cancer was approved in 2004 but discontinued in 2021. The implant requires a minor surgical procedure for insertion and removal/replacement each year. Supprelin LA's main clinical advantage is its 12-month duration — the longest of any GnRH agonist — which is particularly valuable in paediatric patients where treatment compliance over years is important. Clinical studies demonstrated effective suppression of puberty markers in over 97% of patients. The implant has also seen significant off-label use in gender-affirming care as a puberty blocker, where its annual dosing schedule offers practical benefits for adolescent patients and their families.

Goserelin

Approved
GnRH Agonist

Goserelin is marketed as Zoladex by AstraZeneca, available as 3.6 mg monthly and 10.8 mg three-monthly subcutaneous implants. First approved in 1989, it is used in advanced prostate cancer, premenopausal breast cancer, endometriosis, and for thinning the uterine lining before surgical procedures. Goserelin achieves castrate-level testosterone suppression (below 50 ng/dL) within two to four weeks. Its unique implant delivery system means there is no liquid injection, reconstitution, or refrigeration required — a practical advantage in some clinical settings. Like all GnRH agonists, it causes an initial hormone flare before suppression takes effect. Goserelin holds an important niche in breast cancer treatment, where it is used to suppress ovarian function in premenopausal women with hormone-receptor-positive disease, often in combination with aromatase inhibitors.

Nafarelin

Approved
GnRH Agonist

Nafarelin is marketed as Synarel (approved 1990) for endometriosis and central precocious puberty. It requires administration as one spray in each nostril twice daily — a higher frequency than injectable alternatives but avoids needles entirely, which can be a significant advantage for some patients, particularly children. Clinical trials showed symptom improvement in 75–92% of endometriosis patients. However, absorption can be affected by nasal congestion or concurrent use of nasal decongestants, which can be a practical limitation. As with all GnRH agonists, prolonged use leads to bone density loss, and treatment for endometriosis is typically limited to six months. Nafarelin occupies a niche for patients who prefer non-injectable hormone suppression, though it has become less commonly prescribed as longer-acting depot injections and oral alternatives have become available.