CLINICAL TRIALS PROFILE FOR DINOPROSTONE

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All Clinical Trials for dinoprostone

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00140114 ↗	Sublingual Versus Vaginal Misoprostol for Labor Induction at Term	Completed	American University of Beirut Medical Center	Phase 3	2004-01-01	Misoprostol (Cytotec®) is a synthetic prostaglandin E1 analog that has been marketed in the United States since 1988 as a gastric cytoprotective agent. In contradistinction to prostaglandin E2 preparations (dinoprostone, Prepidil, Cervidil), misoprostol is inexpensive and available in scored tablets that can be broken and inserted vaginally. Despite a focused campaign by the manufacturer to curtail its use in obstetric practice, misoprostol has, over the past several years, gained widespread acceptance as both a labor induction and a cervical ripening agent. Such off-label indication has been endorsed by the American College of Obstetricians and Gynecologists and other medical bodies. Recently, FDA approved a new label for the use of cytotec during pregnancy which removed pregnancy as a contraindication for its use. Vaginal administration seems to be more efficacious than when given orally, although there is the worry of uterine tachysystole and hyperstimulation with vaginal doses > 50-µg. The use of sublingual misoprostol for cervical ripening at term was recently investigated in two studies that compared it to the oral route, on the assumption that the sublingual route would have the higher efficacy of the vaginal route by avoiding the first pass effects of the gastrointestinal and hepatic systems, while having lower hyperstimulation rates by avoiding the direct effects on the cervix. In addition, the sublingual route would combine an easier administration with the added advantage of no restriction of mobility after administration. There has been no previous report in the literature comparing the use of misoprostol given sublingually to that given vaginally for the induction of labor at term. Our aim is to compare efficacy, safety and patient satisfaction with misoprostol given vaginally (the current standard) to that given sublingually.
NCT00148473 ↗	Oral Versus Vaginal Misoprostol for Induction of Labor	Completed	Bangkok Metropolitan Administration Medical College and Vajira Hospital	Phase 2/Phase 3	2000-03-01	The purpose of this study is to compare the efficacy between a single dose of oral misoprostol 100 microgram and vaginal misoprostol 50 microgram for induction of labor.
NCT00299754 ↗	Trial Of Misoprostol And Dinoprostone Vaginal Pessaries for Cervical Priming (TROMAD Study)	Completed	National Healthcare Group, Singapore	Phase 3	2003-01-01	Most studies of labour induction with misoprostol used doses higher than 25mg and intervals of 3-4 hours. We studied a low-dose regime of 25mg misoprostol and compared its efficacy as single dose or double dose with dosing interval of 6 hours to our current regime of 3 mg dinoprostone pessary.
NCT00299754 ↗	Trial Of Misoprostol And Dinoprostone Vaginal Pessaries for Cervical Priming (TROMAD Study)	Completed	KK Women's and Children's Hospital	Phase 3	2003-01-01	Most studies of labour induction with misoprostol used doses higher than 25mg and intervals of 3-4 hours. We studied a low-dose regime of 25mg misoprostol and compared its efficacy as single dose or double dose with dosing interval of 6 hours to our current regime of 3 mg dinoprostone pessary.
NCT00308711 ↗	Safety/Efficacy Study Comparing the Misoprostol Vaginal Insert to Cervidil for Cervical Ripening and Induction of Labor	Completed	Ferring Pharmaceuticals	Phase 3	2006-04-01	The purpose of this study is to determine whether the misoprostol vaginal insert (50 mcg and 100 mcg) can safely and effectively speed time to vaginal delivery compared to Cervidil (R) in women who need to have cervical ripneing and induction of labor.

Clinical Trial Conditions for dinoprostone

Condition Name

Condition Name for dinoprostone
Intervention	Trials
Cervical Ripening	16
Induction of Labor	12
Induction of Labor Affected Fetus / Newborn	6
Labor, Induced	6

Condition MeSH

Condition MeSH for dinoprostone
Intervention	Trials
Fetal Membranes, Premature Rupture	8
Rupture	7
Premature Birth	2
Infertility	2

Clinical Trial Locations for dinoprostone

Trials by Country

Trials by Country for dinoprostone
Location	Trials
United States	47
Egypt	22
Japan	13
Korea, Republic of	5
France	4

Trials by US State

Trials by US State for dinoprostone
Location	Trials
Utah	3
Ohio	2
North Carolina	2
New York	2
New Mexico	2

Clinical Trial Progress for dinoprostone

Clinical Trial Phase

Clinical Trial Phase for dinoprostone
Clinical Trial Phase	Trials
PHASE4	2
PHASE1	1
Phase 4	23

Clinical Trial Status

Clinical Trial Status for dinoprostone
Clinical Trial Phase	Trials
Completed	45
Unknown status	15
Not yet recruiting	12

Clinical Trial Sponsors for dinoprostone

Sponsor Name

Sponsor Name for dinoprostone
Sponsor	Trials
Cairo University	18
Ferring Pharmaceuticals	8
Seoul National University Hospital	5

Sponsor Type

Sponsor Type for dinoprostone
Sponsor	Trials
Other	100
Industry	9

Last updated: July 30, 2026

DINOPROSTONE clinical trials update and market projection: what’s in the pipeline, who’s winning, and when demand grows

What is dinoprostone and what products drive the market today?

Dinoprostone is a prostaglandin E2 (PGE2) product used in obstetrics for cervical ripening and induction of labor, typically via vaginal inserts, gels, or other locally delivered formulations.

What dosage forms are typically marketed?

Most commercial dinoprostone brands focus on local delivery for obstetric workflows:

• Vaginal insert systems (controlled-release)
• Vaginal gel and similar topical vaginal dosage forms
• Delivery-system variants designed to standardize release kinetics and reduce dosing variability

How is the market usually segmented?

• Indication: cervical ripening and labor induction (delivery setting)
• Setting: hospital labor and delivery departments
• Country/regulatory market: US, EU5, UK, Canada, LatAm, select Asia markets

What does the clinical trial landscape for dinoprostone look like right now?

DINOPROSTONE clinical development is generally characterized by:

• Reformulation and delivery-system improvements
• Bioavailability/release-rate studies for locally administered PGE2 products
• Comparative trials versus other labor-induction agents, including oxytocin and mechanical or pharmacologic cervical ripening alternatives

What kinds of studies get run for dinoprostone?

• Controlled clinical trials evaluating cervical ripening outcomes (time to active labor, Bishop score change, delivery timing)
• Safety monitoring focused on uterine tachysystole, fetal heart rate effects, and labor complications
• Pharmacokinetic and pharmacodynamic release profiling for device-like vaginal insert systems

What endpoints tend to dominate the readouts?

• Time to onset of active labor
• Proportion achieving vaginal delivery within a defined window
• Cervical change metrics (Bishop score)
• Maternal and fetal safety endpoints (uterine activity abnormalities, fetal distress events)

Which companies are developing or commercializing dinoprostone globally?

Dinoprostone is marketed through branded and generic routes in multiple regions, with competition often concentrated in:

• Obstetric brands that maintain tender presence in hospitals
• Generic entrants tied to local regulatory approvals and distribution contracts
• Manufacturers that differentiate via delivery systems and supply reliability

How do market leaders usually defend share?

• Hospital formulary access and procurement contracts
• Stable supply and consistent product performance
• Clinical support programs focused on labor and delivery protocols

How does dinoprostone compare with competing labor-induction options?

Dinoprostone is used against a set of common competitors in obstetric cervical ripening and induction:

• Oxytocin: widely used for labor induction; lacks the same cervical-ripening mechanism
• Mechanical methods (eg, balloon catheters): used for cervical ripening with different safety and workflow profiles
• Other prostaglandins: vary by formulation, dosing, and safety profile

Where does dinoprostone typically fit in protocols?

• When clinicians target cervical ripening prior to oxytocin or augmentation
• When hospitals follow guideline pathways that list PGE2 options as standard cervical ripening agents

What is the market size and growth outlook for dinoprostone?

DINOPROSTONE market dynamics typically track:

• Birth volumes
• Uptake of guideline-driven cervical ripening protocols
• Hospital procurement practices and price pressure from generics
• Availability constraints and supply continuity

Key drivers for demand growth

• Increasing institutional delivery rates
• Clinical adoption of standardized cervical ripening approaches
• Product availability and formulary stability

Key headwinds

• Generic substitution and price erosion
• Protocol shifts toward competitor modalities in certain settings
• Competition intensity in markets with faster regulatory generic approvals

When does dinoprostone face exclusivity and generic entry risks?

Exclusivity risk for dinoprostone products is usually driven by:

• Patent expiration for specific branded formulations and delivery systems
• Market exclusivity tied to specific NDA/ANDAs
• Device-like product performance claims that can be protected through formulation and release kinetics patents

What to watch for in the exclusivity timeline?

• Patent expirations for branded delivery systems in each geography
• Any Paragraph IV filings if the formulation is protected under Orange Book-listed patents
• Settlement agreements that delay generic launch dates in specific jurisdictions

What is the FDA and Orange Book status of dinoprostone products?

US exclusivity and generic entry risk is determined by:

• Whether the product is listed in FDA’s Orange Book (active listings and expiring patents)
• The specific NDA/ANDA product(s) and the patent categories (drug substance, drug product, method of use)
• Suit status for any Paragraph IV challenges

What submissions typically matter for US risk?

• ANDAs tied to dinoprostone products with bioequivalence data
• Any amendments to ensure product sameness for approval and to overcome formulation differences
• Litigation affecting launch timing

How do clinical outcomes and safety profiles affect market uptake?

Market adoption in labor and delivery is highly protocol-driven and procurement-sensitive, but safety and workflow outcomes drive clinician preference.

What safety signals matter most commercially?

• Uterine tachysystole incidence
• Maternal side effects and need for intervention
• Fetal heart rate changes and monitoring burden
• Overall labor outcomes and rates of successful delivery within target time frames

What benefits translate into procurement decisions?

• Predictable cervical ripening performance
• Reduced labor management complexity
• Consistency across patient populations seen in routine obstetric care

What are the most likely 2025 to 2030 market scenarios for dinoprostone?

Given typical obstetric product dynamics, three scenarios usually play out in mature markets:

1. Base case: slow growth with steady unit volume, declining price with generic mix
2. Downside: accelerated generic substitution plus protocol shifts to competitors in some geographies
3. Upside: stable pricing in tender-led markets plus incremental volume growth from guideline adherence

Market projection framework (high-level)

Projections typically use:

• Birth/admission volumes by geography
• Market penetration rates of cervical ripening protocols
• Product conversion rates among PGE2, mechanical, and oxytocin pathways
• Pricing assumptions based on generic erosion and tender outcomes

What is the clinical trial update you should track next?

For dinoprostone, the highest-signal pipeline updates typically include:

• Comparative clinical studies with other induction and ripening agents
• Updated evidence on delivery-device performance and release kinetics
• New regulatory approvals tied to reformulated or device-adapted versions
• Trial readouts that can shift protocol guidelines or hospital formulary decisions

How strong is the patent estate for dinoprostone formulations and methods of use?

Patent strength for dinoprostone products is usually concentrated in:

• Drug product and delivery system patents (specific formulations, release control, insert/gels design)
• Method-of-use claims tied to cervical ripening or induction protocols
• Process/manufacturing patents that support product performance

What determines enforceability and settlement leverage?

• Scope and claim construction for drug product and method-of-use patents
• Strength of evidence that a generic product design avoids infringement
• Orange Book patent coverage tied to the exact approved formulation

Key Takeaways

• Dinoprostone demand is driven by cervical ripening and labor induction workflows, with growth tied to institutional delivery volumes and guideline use.
• Clinical development is typically dominated by formulation and delivery-system improvements and comparative efficacy/safety studies versus standard obstetric induction approaches.
• Market outlook is likely modest growth in mature settings with pricing pressure from generics, unless delivery-system differentiation sustains premium pricing via formulary access.
• Exclusivity and generic entry risk are determined by Orange Book-listed patent coverage by specific NDA/ANDA products and any Paragraph IV litigation or settlements that delay launch.

FAQs

1. Which dinoprostone dosage forms face the fastest generic substitution risk?
2. What clinical endpoints most influence hospital adoption of dinoprostone cervical ripening products?
3. How do uterine tachysystole and fetal monitoring outcomes affect dinoprostone protocol selection?
4. What does Orange Book patent category coverage (drug substance vs drug product vs method of use) mean for dinoprostone generics?
5. How do tender procurement and hospital formulary policies change dinoprostone pricing across countries?

References

1. FDA Orange Book (HHS/NB). Drugs@FDA / Orange Book database. US Food and Drug Administration.
2. FDA (HHS/NB). Drugs@FDA database. US Food and Drug Administration.