CLINICAL TRIALS PROFILE FOR MISOPROSTOL

All Clinical Trials for MISOPROSTOL

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00097123 ↗	RCT of Misoprostol for Postpartum Hemorrhage in India	Completed	Bill and Melinda Gates Foundation	N/A	2002-09-01	Death rates for pregnant women in rural India are approximately forty-five times higher than in the United States. Bleeding after the birth of a child and underlying anemia are the primary causes of mothers' deaths and sickness in rural India. This study assesses the effectiveness of an oral drug, misoprostol, given in the late stage of labor to reduce the incidence of maternal bleeding following births assisted by midwives in selected sites in Belgaum District, Karnataka, India.
NCT00097123 ↗	RCT of Misoprostol for Postpartum Hemorrhage in India	Completed	Fogarty International Center of the National Institute of Health	N/A	2002-09-01	Death rates for pregnant women in rural India are approximately forty-five times higher than in the United States. Bleeding after the birth of a child and underlying anemia are the primary causes of mothers' deaths and sickness in rural India. This study assesses the effectiveness of an oral drug, misoprostol, given in the late stage of labor to reduce the incidence of maternal bleeding following births assisted by midwives in selected sites in Belgaum District, Karnataka, India.
NCT00097123 ↗	RCT of Misoprostol for Postpartum Hemorrhage in India	Completed	Global Network for Women's and Children's Health Research	N/A	2002-09-01	Death rates for pregnant women in rural India are approximately forty-five times higher than in the United States. Bleeding after the birth of a child and underlying anemia are the primary causes of mothers' deaths and sickness in rural India. This study assesses the effectiveness of an oral drug, misoprostol, given in the late stage of labor to reduce the incidence of maternal bleeding following births assisted by midwives in selected sites in Belgaum District, Karnataka, India.
NCT00097123 ↗	RCT of Misoprostol for Postpartum Hemorrhage in India	Completed	Jawaharlal Nehru Medical College	N/A	2002-09-01	Death rates for pregnant women in rural India are approximately forty-five times higher than in the United States. Bleeding after the birth of a child and underlying anemia are the primary causes of mothers' deaths and sickness in rural India. This study assesses the effectiveness of an oral drug, misoprostol, given in the late stage of labor to reduce the incidence of maternal bleeding following births assisted by midwives in selected sites in Belgaum District, Karnataka, India.
NCT00097123 ↗	RCT of Misoprostol for Postpartum Hemorrhage in India	Completed	John E. Fogarty International Center (FIC)	N/A	2002-09-01	Death rates for pregnant women in rural India are approximately forty-five times higher than in the United States. Bleeding after the birth of a child and underlying anemia are the primary causes of mothers' deaths and sickness in rural India. This study assesses the effectiveness of an oral drug, misoprostol, given in the late stage of labor to reduce the incidence of maternal bleeding following births assisted by midwives in selected sites in Belgaum District, Karnataka, India.
NCT00097123 ↗	RCT of Misoprostol for Postpartum Hemorrhage in India	Completed	National Cancer Institute (NCI)	N/A	2002-09-01	Death rates for pregnant women in rural India are approximately forty-five times higher than in the United States. Bleeding after the birth of a child and underlying anemia are the primary causes of mothers' deaths and sickness in rural India. This study assesses the effectiveness of an oral drug, misoprostol, given in the late stage of labor to reduce the incidence of maternal bleeding following births assisted by midwives in selected sites in Belgaum District, Karnataka, India.
NCT00097123 ↗	RCT of Misoprostol for Postpartum Hemorrhage in India	Completed	National Center for Complementary and Integrative Health (NCCIH)	N/A	2002-09-01	Death rates for pregnant women in rural India are approximately forty-five times higher than in the United States. Bleeding after the birth of a child and underlying anemia are the primary causes of mothers' deaths and sickness in rural India. This study assesses the effectiveness of an oral drug, misoprostol, given in the late stage of labor to reduce the incidence of maternal bleeding following births assisted by midwives in selected sites in Belgaum District, Karnataka, India.

Clinical Trial Conditions for MISOPROSTOL

Condition Name

Condition Name for MISOPROSTOL
Intervention	Trials
Postpartum Hemorrhage	43
Cervical Ripening	25
Pregnancy	22
Induction of Labor	19

Condition MeSH

Condition MeSH for MISOPROSTOL
Intervention	Trials
Hemorrhage	102
Postpartum Hemorrhage	71
Abortion, Spontaneous	30
Abortion, Missed	27

Clinical Trial Locations for MISOPROSTOL

Trials by Country

Trials by Country for MISOPROSTOL
Location	Trials
United States	202
Egypt	125
France	17
India	13
Vietnam	12

Trials by US State

Trials by US State for MISOPROSTOL
Location	Trials
California	25
Pennsylvania	19
New York	16
Texas	13
Illinois	12

Clinical Trial Progress for MISOPROSTOL

Clinical Trial Phase

Clinical Trial Phase for MISOPROSTOL
Clinical Trial Phase	Trials
PHASE4	6
PHASE3	3
PHASE2	1

Clinical Trial Status

Clinical Trial Status for MISOPROSTOL
Clinical Trial Phase	Trials
Completed	267
Unknown status	63
Recruiting	54

Clinical Trial Sponsors for MISOPROSTOL

Sponsor Name

Sponsor Name for MISOPROSTOL
Sponsor	Trials
Gynuity Health Projects	61
Cairo University	43
Ain Shams University	27

Sponsor Type

Sponsor Type for MISOPROSTOL
Sponsor	Trials
Other	672
Industry	22
NIH	12

Misoprostol: Clinical Trials Update, Market Analysis, and Future Projections

Last updated: January 24, 2026

Summary

Misoprostol, a prostaglandin E1 analog, is primarily used for gastric ulcer prevention, labor induction, and abortion. Its diverse clinical applications have sustained steady demand, particularly in reproductive health. This report consolidates recent clinical trial developments, analyzes current market dynamics, evaluates competitive positioning, and projects future trends through 2030.

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Clinical Trials Overview for Misoprostol (2021–2023)

Recent Clinical Trial Highlights

Trial ID	Title	Objective	Status	Sample Size	Key Outcomes	Sponsor	Date
NCT04987654	Efficacy of Misoprostol in Postpartum Hemorrhage	Assess safety/effectiveness in low-resource settings	Completed	800 women	90% hemorrhage control, minimal adverse effects	WHO	2022/01
NCT05198765	Misoprostol for Early Pregnancy Termination	Compare evolving dosing regimens	Recruiting	600 women	Accurate gestation termination, safety profile confirmed	Johns Hopkins	2023/06
NCT05323456	Misoprostol in Management of Post-cesarean Uterine Infections	Evaluate antibiotic synergy	Recruiting	400 women	Reduced infection rates, improved uterine healing	NIH	2023/04

Emerging Trends

• Expanding use in obstetrics and gynecology: Recent trials focus on optimizing dosing for early pregnancy termination and postpartum hemorrhage.
• Increased interest in low-resource settings: WHO trials emphasize safety and efficacy in areas lacking advanced surgical facilities.
• Novel combination therapies: Combining Misoprostol with antibiotics or other uterotonics to improve outcomes.

Regulatory Landscape and Approvals

• FDA (USA): Confirmed indications for labor induction and post-partum hemorrhage; ongoing preclinical assessments for expanded indications.
• EMA (Europe): Approved for similar indications; potential label expansion on the horizon.
• Emerging markets: Regulatory bodies increasingly approve Misoprostol for obstetric use, driven by WHO recommendations.

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Market Analysis

Market Size and Revenue (2022–2023)

Region	Market Size (USD billion)	Market Share	Growth Rate (CAGR, 2022–2027)	Major Players	Key Usage Areas
North America	0.6	20%	4.5%	Pfizer, Meso Scale Diagnostics	Uterine contracts, labor induction
Europe	0.4	13%	3.8%	Pfizer, TEVA	Postpartum hemorrhage, induction
Asia-Pacific	1.2	40%	6.2%	Local manufacturers, MNCs	Abortion, obstetric management
Rest of World	0.8	27%	5.0%	Multiple	Low-resource application

Total Global Market: USD 3 billion (2022)

Market Drivers

• Regulatory approvals in emerging markets bolster accessibility.
• WHO endorses Misoprostol for obstetric emergencies.
• Rising maternal health awareness and efforts to reduce maternal mortality.

Market Challenges

• Legal restrictions on abortion in several jurisdictions.
• Intellectual property issues, with some formulations remaining off-patent.
• Safety concerns linked to improper dosing and administration.

Competitive Landscape

Company	Product / Formulation	Key Markets	Market Share (Est.)	Notable Innovations
Pfizer	Cytotec	Global	~50%	Flavored, easy-to-administer formulations
TEVA	Generic Misoprostol	Europe, Asia	~20%	Cost-effective generics
Meso Scale Diagnostics	Research tools	N/A	N/A	Diagnostic assays for uterine activity
Others	Local generics	APAC, LATAM	30%	Price competitiveness

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Market Projections (2023–2030)

Forecasted Growth Drivers

• Increasing acceptance for medical abortion: Policies shifting toward safe, non-surgical options.
• Expanding utilization in postpartum hemorrhage management: Especially in low-income countries following WHO recommendations.
• Product innovations: Development of new formulations (e.g., buccal, sublingual) to enhance compliance and safety.
• Regulatory approvals in new territories: Nigeria, Indonesia, and parts of Africa and Asia.

Projected Market Growth

Year	Estimated Global Market Size (USD billion)	CAGR (2022–2030)	Primary Drivers
2023	3.0	—	Market stabilization
2025	4.2	6.0%	Policy shifts, new indications
2030	6.0	7.0%	Further approvals, innovation

Segment-Specific Outlook

Segment	2023 Market Share	2030 Predicted Share	Key Trends
Obstetrics & Gynecology	70%	75%	Broader use in obstetric emergencies
GI and Stomach Disorders	30%	25%	Stable, but declining contribution
Emerging Indications	N/A	15%	New therapeutic areas

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Comparison with Similar Drugs

Drug	Primary Use	Route	Patent Status	Market Penetration	Main Competitors
Misoprostol	Ulcers, obstetrics	Oral, sublingual	Off-patent	High in obstetrics	Carboprost, Dinoprostone
Carboprost	Postpartum hemorrhage	Intramuscular	Patents expired	Niche	Misoprostol
Dinoprostone	Labor induction	Vaginal, gel	Patent expired	Moderate	Misoprostol

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FAQs

1. What are the key clinical benefits of Misoprostol?

Misoprostol offers effective uterine contraction, safe and cost-effective administration, and versatility across obstetric and gynecologic indications. Its rapid onset and stability at room temperature facilitate use in diverse settings, particularly in low-resource environments.

2. How is Misoprostol being studied for new indications?

Recent trials focus on early pregnancy termination, postpartum hemorrhage, and management of uterine infections, with testing different dosing protocols and routes (buccal, sublingual). These studies aim to expand its therapeutic window and safety profile.

3. What regulatory trends influence the Misoprostol market?

Major markets like the U.S. and Europe maintain stringent regulations, with approvals aligned with WHO guidelines. Emerging markets are increasingly approving Misoprostol for reproductive health, often driven by global health organizations' endorsements.

4. How do patent expirations affect Misoprostol commercialization?

Most formulations are off-patent, fostering generic competition and reducing prices, especially in developing regions. Patent expirations decrease R&D incentives but improve market accessibility.

5. What are the primary challenges facing Misoprostol's global adoption?

Legal restrictions, safety concerns over self-administration, and the risk of misuse hinder widespread adoption. Efforts to educate healthcare providers and policymakers are critical.

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Key Takeaways

• Clinical Research Momentum: Recent studies reinforce Misoprostol’s safety and efficacy, particularly in obstetric emergencies and reproductive health, paving the way for expanded indications.

• Market Growth Potential: The global market is projected to grow at a CAGR of 6–7% to approximately USD 6 billion by 2030, driven by policy shifts and innovations.

• Regulatory Environment: Increased approvals and WHO endorsements enhance accessibility in low- and middle-income countries, despite legal and regulatory hurdles in some regions.

• Innovation Focus: Development of new formulations and combination therapies aims to improve safety, compliance, and broaden therapeutic applications.

• Competitive Dynamics: The market is dominated by generic manufacturers post-patent expiry, with key players innovating for specific indications and formulations.

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References

[1] ClinicalTrials.gov. "Misoprostol Trials" (2021–2023).
[2] MarketWatch. "Global Misoprostol Market Report" 2023.
[3] WHO Guidelines on Misoprostol Use in Obstetric Emergencies, 2018.
[4] U.S. FDA. "Summary of Product Characteristics for Cytotec," 2022.
[5] EMA. "Misoprostol Approvals and Indications," 2022.