NDAINJECTIONINJECTABLE
Approved
Jul 1980
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
20
Data completeness
3/8 — Basic
OXYTOCIN (oxytocin) by Fresenius Kabi is clinical pharmacology oxytocin injection (synthetic) acts on the smooth muscle of the uterus to stimulate contractions; response depends on the uterine threshold of excitability. First approved in 1980.
Drug data last refreshed 13h ago · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
Oxytocin is a synthetic injectable oxytocic agent that mimics the naturally occurring posterior pituitary hormone to stimulate uterine contractions. It is used to induce or augment labor and to control postpartum hemorrhage by increasing the frequency and tone of uterine contractions. The drug acts selectively on uterine smooth muscle without the cardiovascular side effects associated with vasopressin.
LOE Approaching
Oxytocin faces moderate competitive pressure (30/100) as a mature, essential obstetric agent with limited growth prospects and likely consolidating team structures.
Mechanism of Action
CLINICAL PHARMACOLOGY Oxytocin injection (synthetic) acts on the smooth muscle of the uterus to stimulate contractions; response depends on the uterine threshold of excitability. It exerts a selective action on the smooth musculature of the uterus, particularly toward the end of pregnancy, during…
Pharmacologic Class:
Oxytocic
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (20)
Effects of Intranasal Oxytocin in Patients With Arginine-vasopressin Deficiency
Started Sep 2025
40 enrolled
Vasopressin Deficiency
Effects of Carbetocin and Oxytocin Used in Cesarean Sections on Postoperative Pain
Started Oct 2024
Changes in Hemorrhage With Prophylactic Oxytocin for Dilation and Evacuation
Started May 2024
150 enrolled
Hemorrhage
Oxytocin Effects on Bone in Children With Autism Spectrum Disorder
Started Aug 2023
96 enrolled
Autism Spectrum DisorderBone Health
Oxytocin on Cold Water Task Performance and Recovery
Started May 2022
17 enrolled
Cold Exposure
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.