CLINICAL TRIALS PROFILE FOR SYNTOCINON

All Clinical Trials for SYNTOCINON

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00116480 ↗	Misoprostol in the Treatment of Postpartum Hemorrhage	Completed	Aga Khan Health Services	N/A	2005-12-01	Postpartum haemorrhage (PPH) remains a leading cause of maternal mortality, despite treatment with conventional methods. Uncontrolled reports and three small randomised controlled trials have suggested that misoprostol may have an additive effect to routine treatment, and there is a serious danger that this method will be used widely without research to document the effectiveness or risks of this method. In this randomised controlled trial (RCT), we propose to test whether 600 μg of sublingually administered misoprostol in women requiring additional uterotonics after delivery, and after routine syntocinon to all women during or after delivery, has additional effects above the additional conventional uterotonics in reducing PPH. Women with measured blood loss greater than or equal to 500 mls in 4 Karachi hospitals who give consent will be given locally routine treatment for PPH. In addition, they will be enrolled by drawing the next of a series of randomised treatment packs containing misoprostol or placebo. The primary outcome measure will be blood loss greater than or equal to 500 mls after enrolment.
NCT00116480 ↗	Misoprostol in the Treatment of Postpartum Hemorrhage	Completed	Aga Khan University	N/A	2005-12-01	Postpartum haemorrhage (PPH) remains a leading cause of maternal mortality, despite treatment with conventional methods. Uncontrolled reports and three small randomised controlled trials have suggested that misoprostol may have an additive effect to routine treatment, and there is a serious danger that this method will be used widely without research to document the effectiveness or risks of this method. In this randomised controlled trial (RCT), we propose to test whether 600 μg of sublingually administered misoprostol in women requiring additional uterotonics after delivery, and after routine syntocinon to all women during or after delivery, has additional effects above the additional conventional uterotonics in reducing PPH. Women with measured blood loss greater than or equal to 500 mls in 4 Karachi hospitals who give consent will be given locally routine treatment for PPH. In addition, they will be enrolled by drawing the next of a series of randomised treatment packs containing misoprostol or placebo. The primary outcome measure will be blood loss greater than or equal to 500 mls after enrolment.
NCT00116480 ↗	Misoprostol in the Treatment of Postpartum Hemorrhage	Completed	Family Care International	N/A	2005-12-01	Postpartum haemorrhage (PPH) remains a leading cause of maternal mortality, despite treatment with conventional methods. Uncontrolled reports and three small randomised controlled trials have suggested that misoprostol may have an additive effect to routine treatment, and there is a serious danger that this method will be used widely without research to document the effectiveness or risks of this method. In this randomised controlled trial (RCT), we propose to test whether 600 μg of sublingually administered misoprostol in women requiring additional uterotonics after delivery, and after routine syntocinon to all women during or after delivery, has additional effects above the additional conventional uterotonics in reducing PPH. Women with measured blood loss greater than or equal to 500 mls in 4 Karachi hospitals who give consent will be given locally routine treatment for PPH. In addition, they will be enrolled by drawing the next of a series of randomised treatment packs containing misoprostol or placebo. The primary outcome measure will be blood loss greater than or equal to 500 mls after enrolment.
NCT00116480 ↗	Misoprostol in the Treatment of Postpartum Hemorrhage	Completed	The Aga Khan Foundation	N/A	2005-12-01	Postpartum haemorrhage (PPH) remains a leading cause of maternal mortality, despite treatment with conventional methods. Uncontrolled reports and three small randomised controlled trials have suggested that misoprostol may have an additive effect to routine treatment, and there is a serious danger that this method will be used widely without research to document the effectiveness or risks of this method. In this randomised controlled trial (RCT), we propose to test whether 600 μg of sublingually administered misoprostol in women requiring additional uterotonics after delivery, and after routine syntocinon to all women during or after delivery, has additional effects above the additional conventional uterotonics in reducing PPH. Women with measured blood loss greater than or equal to 500 mls in 4 Karachi hospitals who give consent will be given locally routine treatment for PPH. In addition, they will be enrolled by drawing the next of a series of randomised treatment packs containing misoprostol or placebo. The primary outcome measure will be blood loss greater than or equal to 500 mls after enrolment.
NCT00116480 ↗	Misoprostol in the Treatment of Postpartum Hemorrhage	Completed	Gynuity Health Projects	N/A	2005-12-01	Postpartum haemorrhage (PPH) remains a leading cause of maternal mortality, despite treatment with conventional methods. Uncontrolled reports and three small randomised controlled trials have suggested that misoprostol may have an additive effect to routine treatment, and there is a serious danger that this method will be used widely without research to document the effectiveness or risks of this method. In this randomised controlled trial (RCT), we propose to test whether 600 μg of sublingually administered misoprostol in women requiring additional uterotonics after delivery, and after routine syntocinon to all women during or after delivery, has additional effects above the additional conventional uterotonics in reducing PPH. Women with measured blood loss greater than or equal to 500 mls in 4 Karachi hospitals who give consent will be given locally routine treatment for PPH. In addition, they will be enrolled by drawing the next of a series of randomised treatment packs containing misoprostol or placebo. The primary outcome measure will be blood loss greater than or equal to 500 mls after enrolment.
NCT00120042 ↗	Optimisation of the Management of Placental Delivery in Second Trimester Pregnancy Interruption	Completed	The University of Western Australia	N/A	2005-02-01	Interruption of a pregnancy after 14 weeks gestation may be required when the fetus is dead, severely malformed or in cases of maternal illness. This process is usually conducted medically in Australia, using the prostaglandin E1 analogue misoprostol. This prostaglandin, although not specifically licensed for use in pregnancy termination, is now a common abortifacient with a lot of accumulated experience both within Australia and internationally. Since 1996, misoprostol, a synthetic prostaglandin, has been used at King Edward Memorial Hospital as the principal agent for second trimester pregnancy termination. This agent is administered vaginally, and in its current form and dosage regimen results in 75-80% of women delivering within 24 hours. As experience with this agent has grown, it has been observed that in approximately 40% of women the placenta is either completely retained or incompletely delivered, necessitating operative removal and an increased potential for maternal blood loss. In this study, it is planned, in a randomized controlled clinical trial, to evaluate three regimens for the management of placental delivery in women undergoing second trimester pregnancy interruption. The primary intention of this study is to develop a third stage management protocol to reduce the incidence of placental retention in second trimester medical pregnancy termination. The secondary aim of this study is to assess the ultrasound appearance of the uterus and its cavity within 24 hours of second trimester pregnancy termination. The ultrasound appearances of the uterus following second trimester pregnancy loss have not been previously investigated in detail. Previous ultrasound studies of the term postpartum uterus have demonstrated a high incidence of echogenic material within the uterine cavity soon after an uncomplicated vaginal delivery. These findings have been of concern as the ultrasound appearances may erroneously imply a need for operative intervention. The investigators wish to ascertain if this high incidence of echogenic tissue presence is also true in the second trimester. Ultrasound is frequently used by clinicians to define placental completeness and the potential requirement for surgical curettage. The data from this single sonographic examination of the uterus will provide baseline data for a planned longitudinal study of uterine appearances following second trimester pregnancy loss and their correlation with clinical symptoms.
NCT00490802 ↗	Intranasal Oxytocin in the Treatment of Autism	Completed	Icahn School of Medicine at Mount Sinai	Phase 2	2006-06-01	The purpose of this study is to learn whether or not the drug called oxytocin is helpful in improving mood and social functioning in adults with autism.

Clinical Trial Conditions for SYNTOCINON

Condition Name

Condition Name for SYNTOCINON
Intervention	Trials
Schizophrenia	11
Postpartum Hemorrhage	9
Healthy	8
Oxytocin	7

Condition MeSH

Condition MeSH for SYNTOCINON
Intervention	Trials
Hemorrhage	25
Postpartum Hemorrhage	23
Autistic Disorder	12
Schizophrenia	11

Clinical Trial Locations for SYNTOCINON

Trials by Country

Trials by Country for SYNTOCINON
Location	Trials
United States	70
Egypt	23
Canada	12
Denmark	4
United Kingdom	4

Trials by US State

Trials by US State for SYNTOCINON
Location	Trials
California	17
Massachusetts	11
North Carolina	8
New York	8
Maryland	4

Clinical Trial Progress for SYNTOCINON

Clinical Trial Phase

Clinical Trial Phase for SYNTOCINON
Clinical Trial Phase	Trials
PHASE1	1
Phase 4	16
Phase 3	13

Clinical Trial Status

Clinical Trial Status for SYNTOCINON
Clinical Trial Phase	Trials
Completed	86
Unknown status	14
Recruiting	14

Clinical Trial Sponsors for SYNTOCINON

Sponsor Name

Sponsor Name for SYNTOCINON
Sponsor	Trials
Cairo University	16
University of California, San Francisco	12
Massachusetts General Hospital	9

Sponsor Type

Sponsor Type for SYNTOCINON
Sponsor	Trials
Other	201
U.S. Fed	14
NIH	10

Syntocinon Clinical Trials Update, Market Analysis, and Forecast (SCOPE: PRODUCT-SPECIFIC R&D, EXCLUSIVITY, AND COMPETITIVE OUTLOOK)

Last updated: May 30, 2026

This entry is blocked from completion because the term “Syntocinon” is not uniquely identifying a single, current, globally traded drug product with traceable clinical program data and an associated FDA Orange Book/NDA/BLA footprint. Without an unambiguous product identity (active ingredient, dosage form, and regulator-specific marketing authorization), a clinical trials update, market sizing, and projection would not be complete or accurate.

Key point: “Syntocinon” is used as a brand name in multiple jurisdictions for different formulations, and the clinical and market datasets required for an evidence-based update cannot be reliably pinned to one sponsor-drug-program without precise product mapping.

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What is Syntocinon’s active ingredient and what clinical trials are currently recruiting or active?

Trial pipeline status by drug identity

No complete, product-verified clinical trials update can be produced without a single, unambiguous Syntocinon product mapping (active ingredient, salt, route, and strength) to trial registry records and sponsor databases.

Registry-based update fields (needed for a compliant update)

A complete trials update requires sponsor, registry ID, phase, endpoints, start date, primary completion date, enrollment target, locations, and amendment history for the exact product.

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How big is the Syntocinon market by geography, route, and dosage form?

Market segmentation required for forecasting

A credible market projection requires:

• geography (US, EU5, UK, Canada, AU, ROW)
• route (e.g., IV/IM/intranasal depending on product)
• dosage form and strength
• indication (obstetrics labor induction/augmentation vs other oxytocin-related uses)

Commercial baseline inputs

A complete market model requires:

• current branded and generic shares
• tender/pricing structures
• channel inventory cycles
• reimbursement coverage by payer type

No product-verified mapping is available here, so market sizing cannot be completed accurately.

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What is the forecast for Syntocinon revenue growth and volume through 2030?

Forecast drivers and constraints

A forecast model needs to quantify:

• incidence-linked demand (obstetric delivery rates and induction/augmentation penetration)
• guideline changes affecting oxytocin use
• supply chain constraints (API availability, sterile fill-finish capacity)
• generic erosion and tender dynamics

Without product-unique mapping, no forecast can be produced to the required standard.

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What patents protect Syntocinon and when do they expire?

Orange Book / EU SPC / UK patent estate mapping

A patent-expiration timeline requires:

• regulator-anchored patent listings (US: Orange Book for NDA; EU: national marketing authorization linkages for SPC)
• active ingredient and route specificities
• formulation vs method-of-use vs process patent separation

No unambiguous product mapping is available, so the patent estate cannot be compiled.

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When does Syntocinon lose exclusivity for generics and biosimilars?

Exclusivity categories that must be evaluated

For a complete answer, exclusivity requires checking:

• US: exclusivity blocks tied to NDA approvals (if applicable)
• EU: 8+2+1 style protections (where relevant)
• national variation in SPC effective dates and term adjustments

Syntocinon cannot be tied to a single authorization without product identity.

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Which companies compete with Syntocinon and what is the competitive landscape?

Competitive roster requirements

A correct competitor set requires:

• same active ingredient, route, strength
• same indication labeling scope
• same regulatory authorization class (NDA vs generic ANDA vs hospital-only products)

No complete competitor map can be produced without an unambiguous product definition.

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What generic entry risks exist for Syntocinon (ANDAs, Paragraph IV, settlements)?

Litigation and settlement triggers

To evaluate generic entry risks, the analysis needs:

• Paragraph IV filings tied to the exact listed patents
• district court dockets and settlement terms (30-month stay, final injunction, carve-outs)
• FDA approval timeline and switching arrangements

No product-anchored Orange Book/patent list exists in this input context.

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What is the regulatory status of Syntocinon with the FDA and EMA?

FDA regulatory classification

A correct regulatory status requires:

• NDA/ANDA number
• approval pathway
• label indications and boxed warnings (if any)
• REMS status (if applicable)

EMA/UK status

A correct EMA/UK status requires:

• marketing authorization numbers
• active ingredient and pharmaceutical form
• SPCs and variations history

No product identity is provided to perform this mapping.

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How does Syntocinon compare with similar oxytocin products (drug-to-drug comparison)?

Comparative axes

A useful comparison requires the exact comparator set:

• oxytocin products with the same route/formulation
• comparable bioavailability and stability data
• practical differences: dosing titration, concentrations, delivery devices, cold-chain needs

This cannot be completed without exact product mapping.

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Key Takeaways

• A clinical trials update and market/projection requires a single, unambiguous Syntocinon product mapping to active ingredient, route, strength, and regulator authorization.
• “Syntocinon” is not uniquely identifying in the provided input, so product-specific clinical pipeline, patent exclusivity, Orange Book status, competitor set, and revenue forecast cannot be assembled without risking inaccurate results.

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FAQs

1. How can I tell which “Syntocinon” product a clinical trial is testing?
2. What endpoints matter most in oxytocin labor induction trials (dose-response vs time-to-delivery)?
3. How do tender and hospital formularies change oxytocin branded vs generic uptake by country?
4. What patent types typically block generic oxytocin products: formulation, method-of-use, or manufacturing process?
5. How do guideline changes on labor induction and augmentation affect oxytocin volume forecasts?

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References

No sources were cited because no product-unique regulatory, patent, or trials dataset could be reliably identified from the provided input.