PITOCIN (oxytocin)
PITOCIN is indicated for the treatment of Diabetes; Preeclampsia; Premature Rupture of Membranes; Uterine Inertia; Incomplete Abortion; Inevitable Abortion; Postpartum Hemorrhage.
Development Insights
Details
- Status
- Prescription
- First Approved
- 1980-11-19
- Routes
- INJECTION
- Dosage Forms
- INJECTABLE
PITOCIN Approval History
What PITOCIN Treats
7 indicationsPITOCIN is approved for 7 conditions since its original approval in 1980. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Diabetes
- Preeclampsia
- Premature Rupture of Membranes
- Uterine Inertia
- Incomplete Abortion
- Inevitable Abortion
- Postpartum Hemorrhage
PITOCIN Boxed Warning
IMPORTANT NOTICE Elective induction of labor is defined as the initiation of labor in a pregnant individual who has no medical indications for induction. Since the available data are inadequate to evaluate the benefits-to-risks considerations, Pitocin is not indicated for elective induction of labor....
IMPORTANT NOTICE Elective induction of labor is defined as the initiation of labor in a pregnant individual who has no medical indications for induction. Since the available data are inadequate to evaluate the benefits-to-risks considerations, Pitocin is not indicated for elective induction of labor.
PITOCIN Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
What's emerging in PITOCIN's indications
See all emerging drugs →Phase 3 candidates targeting molecules with no FDA-approved drug, in indications PITOCIN treats. First-in-class if their pivotal trials read out positive.
Drugs Similar to PITOCIN
3 of 20FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
156 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT07401524 CUTT-PPH | SMC-26-2925 | Ph 4 | recruiting | Carbetocin Uterotonic Treatment in Twin Pregnancies for Prevention of Postpartum Hemorrhage |
| NCT03860233 | GWU_IRB_031857 | Ph 1 | recruiting | Benefits of Oxytocin in Obstructive Sleep Apnea (OSA) Patients Using Continuous Positive Airway Pressure (CPAP) Machine |
| NCT06259097 BLOOM | STUDY-24-00118 | Ph 3 | recruiting | Different Medications to Induce Labor |
| NCT04228289 results posted | MHBB-001-19S | Ph 2 | completed | Oxytocin to Treat PTSD |
| NCT03899961 CMT2014/2 results posted | 2014/1210 | Ph 4 | completed | Carbetocin Myocardium Trial 2014 Part 2 |
| NCT03900754 results posted | MHBB-011-18F 19-27265, 1I01CX001761-01A2 | Ph 2 | terminated | A Pharmaco-imaging Approach to Predicting Social Functioning and Clinical Responses to Oxytocin Administration in Schizophrenia |
| NCT06651476 | IRB00120861 5P01NS119159 | Ph 2 | completed | A Randomized Controlled Trial to Test the Effects Oxytocin and Vibration Have on Heat Pain Threshold After UV-B Burn |
| NCT06483659 | 2024P001376 | Ph 2 | recruiting | Intravenous Oxytocin for Post Operative Pain After Minimally Invasive Hysterectomy |
| NCT04427709 | IRB00066475 5P01NS119159-02 | Ph 2 | recruiting | Generate and Test the Reliability of a PD Model of OXT on Pupillary Hippus as a Measure of CNS Activity |
| NCT02804373 PRADOTIM | 13 6872 03 | Ph 2, Ph 3 | completed | Effects of Intranasal Administration of Oxytocin in Adults With Prader-Willi Syndrome |
| NCT04949633 OPIC | DR200090 2021-000989-15 | Ph 3 | recruiting | Oxytocin vs Prostaglandins for Labor Induction of Women With an Unfavorable Cervix After 24h of Cervical Ripening |
| NCT05929339 results posted | IRB00097699 1P01NS119159-01A1 | Ph 2 | completed | Defining a PK and PD Model for Peripheral Analgesia After IV Oxytocin |
| NCT04431206 results posted | IRB00066136 | Ph 2 | terminated | Generate a Pharmacodynamic Model of Oxytocin for Peripheral Analgesic Effects |
| NCT06725004 | 4221 | Ph 3 | completed | Oxytocin Versus Human Chorionic Gonadotropin as Trigger in Ovulation Induction |
| NCT05405257 EDS-OXY results posted | H-45648 | Ph 1, Ph 2 | terminated | Oxytocin for Hypermobile Ehlers-Danlos Syndrome |
| NCT07119398 | 24-04-FB-0086 | Ph 4 | recruiting | Oxytocin/Foley vs. Oxytocin for Induction in Patients With PPROM |
| NCT04429880 | IRB00065787 | Ph 2 | withdrawn | A Study of Oxytocin PK After IV Administration in Healthy Subjects and Advanced Knee Arthritis Subjects |
| NCT04117243 | 280391 | Ph 2 | completed | Tranexamic Acid Versus Sublingual Misoprostol in Reducing Blood Loss During Elective CS in High Risk Cases |
| NCT02979093 results posted | 201601749 | Ph 2 | terminated | Oxytocin and Brain Responses in Maternal Addiction |
| NCT02505984 IN-OXT results posted | 2015P001100 224421, 225686 | Ph 2 | completed | Preventing Postpartum Depression With Intranasal Oxytocin |
| NCT03846505 results posted | Pro00082233 1R01AA027212 | Ph 2 | completed | Oxytocin to Enhance Alcohol Behavioral Couple Therapy (ABCT) |
| NCT05326776 POPP results posted | 802467 | Ph 2 | completed | Peripheral Oxytocin and Touch |
| NCT03749902 MOLI | 4007 | Ph 4 | completed | A Randomized Trial of Oral Misoprostol Alone Versus Oral Misoprostol Followed by Oxytocin for Labour Induction |
| NCT06550089 HOLDOUT | IRB24-0398 | Ph 2 | withdrawn | High Or Low Dose pOstpartUm Oxytocin at the Time of Cesarean Birth |
| NCT04433741 | IRB00066443 | Ph 2 | withdrawn | Apply the PD Model of Peripheral Oxytocin Action to a Multimodal Stimulus |
| NCT04435704 | IRB00066138 | Ph 2 | withdrawn | Validate a Pharmacodynamic Model of Oxytocin for Peripheral Analgesic Effects |
| NCT06010368 | AN2023-3 | Ph 3 | not yet recruiting | Comparing Intramyometrial Tranexamic Acid and Oxytocin for Blood Loss in Cesarean Section |
| NCT06514586 | Oxagon | Ph 3 | not yet recruiting | The Efficacy of Topical Vaginal Oxytocin Gel in Postmenopausal Women With Vulvovaginal Atrophy |
| NCT03819231 MOXY | HS-17-00972 | Ph 2, Ph 3 | terminated | Mindfulness Training Plus Oxytocin Effects on Smoking Behavior |
| NCT04028765 POM PROM results posted | 833536 | Ph 4 | completed | Pitocin or Oral Misoprostol for PROM IOL |
| NCT02918864 ION-ASD results posted | 14062403 | Ph 2 | completed | Oxytocin and Social Cognitive Skills Groups |
| NCT02205034 OTBB2 results posted | 12 391 02 1239102 | Ph 1, Ph 2 | completed | Evaluation of Tolerance, Suckling and Food Intake After Repeated Nasals Administrations of Oxytocin in PWS Infants |
| NCT02503319 TRANOXY2015 | AzUSL1 di Massa e Carrara | Ph 3 | withdrawn | Clinical Study to Assess the Equivalence of Tranexamic Acid vs Oxytocin in Reducing the PPH (TRANOXY2015) |
| NCT02775773 TRANOXY2016 | Azenda USLToscana Nord Ovest | Ph 3 | completed | Clinical Study to Assess the Equivalence of Tranexamic Acid vs Oxytocin in Reducing the PPH |
| NCT02824627 results posted | 0321-16-FB | Ph 2 | completed | Oxytocin on Irritability/Emotional Dysregulation of Disruptive Behavior and Mood Disorders |
| NCT05627791 | 65065 | Ph 2, Ph 3 | terminated | Effects of Vaginal Oxytocin Gel on Vaginal Cytologic Parameters in Postmenopausal Woman |
| NCT05608070 | 2022P000895 | Ph 4 | withdrawn | IV Oxytocin for Post Operative Pain After Minimally Invasive Hysterectomy |
| NCT03680339 | 42 | Ph 4 | completed | The Effect of Preoperative and Post Operative Misoprostol Administration on Intraoperative Blood Loss and Postpartum Hemorrhage in CS |
| NCT03651882 | BASEC-Nr: 2017-01750 | Ph 4 | completed | Oxytocin i.m./i.v. Versus Carbetocin i.v. in Elective Cesarean Sections |
| NCT02485444 | 2015-80 | Ph 4 | completed | Oxytocin Infusion vs. Spontaneous Follow-up for Third-stage of Labor After Second-trimester Abortion |
| NCT05340205 | Placenta previa disorders | Ph 4 | completed | Blood Loss During Cesarean Delivery in Placenta Previa Patients |
| NCT04431193 | IRB00066130 | Ph 2 | withdrawn | Estimate Serum Oxytocin PD Range in the Periphery |
| NCT03140488 OPS results posted | 1702231223 | Ph 4 | completed | Oxytocin Dosage to Decrease Induction Duration |
| NCT03011307 results posted | IRB00036246 | Ph 2 | terminated | Efficacy of Intrathecal Oxytocin to Speed Recovery After Hip Surgery |
| NCT04105998 results posted | IRB00060838 | Ph 4 | completed | Effects of Intramuscular (IM) Oxytocin on Pupil Diameter and Heart Rate Variability (HRV) |
| NCT04210310 results posted | 19-01381 | Ph 3 | terminated | High Dose Oxytocin Nasal Spray for Treatment of Tinnitus |
| NCT03370510 results posted | 2000021581 | Ph 2 | terminated | Translating Neuroprediction Into Precision Medicine Via Brain Priming |
| NCT03096249 | SingleOT_EEG_S56327 | Ph 1, Ph 2 | completed | The Influence of Oxytocin on Socio-communicative Sensitivity |
| NCT03865615 | Oxytocin Approach | Ph 2 | withdrawn | Oxytocin on Approach Bias and Craving |
| NCT03463993 results posted | ETAPPPH | Ph 3 | completed | Efficacy of Tranexamic Acid in Preventing Postpartum Haemorrhage After Elective Caesarean Section |
Showing 50 of 156 trials
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
PITOCIN FDA Label Details
Indications & Usage
FDA Label (PDF)PITOCIN is indicated for the treatment of Diabetes; Preeclampsia; Premature Rupture of Membranes; Uterine Inertia; Incomplete Abortion; Inevitable Abortion; Postpartum Hemorrhage.
IMPORTANT NOTICE Elective induction of labor is defined as the initiation of labor in a pregnant individual who has no medical indications for induction. Since the available data are inadequate to evaluate the benefits-to-risks considerations, Pitocin is not indicated for elective induction of labor...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment