CLINICAL TRIALS PROFILE FOR MAKENA

All Clinical Trials for Makena

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT01004029 ↗	Confirmatory Study of 17P vs Vehicle for Prevention of Preterm Birth in Women w/ Previous Spontaneous Preterm Delivery	Completed	AMAG Pharmaceuticals, Inc.	Phase 3	2009-10-01	As part of the continuing effort to study the benefit and risks of 17P and preterm delivery, this study is designed as a multi-center, randomized, double-blind, vehicle-controlled clinical trial of 17P for the prevention of preterm birth prior to 35 weeks, 0 days of gestation in women with a singleton pregnancy, aged 18 years or older, with a previous singleton spontaneous preterm delivery. The study also includes a population pharmacokinetic (PK) substudy to assess the hydroxyprogesterone caproate (HPC) exposure-response relationship and the effect of body mass index (BMI) on the PK of 17P.
NCT01004029 ↗	Confirmatory Study of 17P vs Vehicle for Prevention of Preterm Birth in Women w/ Previous Spontaneous Preterm Delivery	Completed	ResearchPoint Global	Phase 3	2009-10-01	As part of the continuing effort to study the benefit and risks of 17P and preterm delivery, this study is designed as a multi-center, randomized, double-blind, vehicle-controlled clinical trial of 17P for the prevention of preterm birth prior to 35 weeks, 0 days of gestation in women with a singleton pregnancy, aged 18 years or older, with a previous singleton spontaneous preterm delivery. The study also includes a population pharmacokinetic (PK) substudy to assess the hydroxyprogesterone caproate (HPC) exposure-response relationship and the effect of body mass index (BMI) on the PK of 17P.
NCT01004029 ↗	Confirmatory Study of 17P vs Vehicle for Prevention of Preterm Birth in Women w/ Previous Spontaneous Preterm Delivery	Completed	Lumara Health, Inc.	Phase 3	2009-10-01	As part of the continuing effort to study the benefit and risks of 17P and preterm delivery, this study is designed as a multi-center, randomized, double-blind, vehicle-controlled clinical trial of 17P for the prevention of preterm birth prior to 35 weeks, 0 days of gestation in women with a singleton pregnancy, aged 18 years or older, with a previous singleton spontaneous preterm delivery. The study also includes a population pharmacokinetic (PK) substudy to assess the hydroxyprogesterone caproate (HPC) exposure-response relationship and the effect of body mass index (BMI) on the PK of 17P.
NCT01119963 ↗	Progesterone (17P, Makena®) for Prolongation of Pregnancy in Women With Preterm Rupture of the Membranes (PROM)	Completed	Obstetrix Medical Group	Phase 2/Phase 3	2011-10-01	The objective of the study is to determine if a weekly dose of 17 hydroxyprogesterone caproate (17P, Makena®) given to women with preterm rupture of the membranes will: 1. increase the probability of continuing the pregnancy until a favorable gestational age. 2. increase the interval between randomization and delivery. 3. decrease neonatal morbidity.

Clinical Trial Conditions for Makena

Condition Name

Condition Name for Makena
Intervention	Trials
Preterm Delivery	1
Assessing Injection Pain of Makena® (Hydroxyprogesterone Caproate Injection, 250 mg/mL) in Healthy Post-menopausal Women	1
Comparing Bioavailability When Makena® is Administered in Healthy Post-menopausal Women	1
Pregnancy	1

Condition MeSH

Condition MeSH for Makena
Intervention	Trials
Premature Birth	3
Rupture	1

Clinical Trial Locations for Makena

Trials by Country

Trials by Country for Makena
Location	Trials
United States	48
Canada	3
Czechia	3
Czech Republic	3
Hungary	2

Trials by US State

Trials by US State for Makena
Location	Trials
California	4
Florida	3
Wisconsin	2
Washington	2
Texas	2

Clinical Trial Progress for Makena

Clinical Trial Phase

Clinical Trial Phase for Makena
Clinical Trial Phase	Trials
Phase 4	1
Phase 3	2
Phase 2/Phase 3	1

Clinical Trial Status

Clinical Trial Status for Makena
Clinical Trial Phase	Trials
Completed	5
Terminated	1

Clinical Trial Sponsors for Makena

Sponsor Name

Sponsor Name for Makena
Sponsor	Trials
AMAG Pharmaceuticals, Inc.	4
Lumara Health, Inc.	2
ResearchPoint Global	1

Sponsor Type

Sponsor Type for Makena
Sponsor	Trials
Industry	7
Other	6

Clinical Trials Update, Market Analysis, and Projection for MAKENA

Last updated: February 6, 2026

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What is the current status of MAKENA's clinical development?

MAKENA (hydroxyprogesterone caproate) was approved by the FDA in 2011 as a prophylactic treatment for recurrent preterm birth in women with a history of spontaneous preterm birth. The drug's approval was based on a pivotal trial involving 463 women, demonstrating a significant reduction in preterm delivery before 37 weeks.

Recent updates indicate no ongoing or planned large-scale phase III trials for MAKENA, as the drug has been marketed since 2011. The focus has shifted to post-approval studies and real-world evidence collection to support its safety and efficacy profile.

Key Points:

• No recent phase III trials launched for MAKENA.
• Ongoing registry-based studies assess safety and long-term outcomes.
• Regulatory agencies have not announced restrictions or recalls recently.

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How has MAKENA's market landscape evolved?

Market Size and Share:

The global market for preterm birth prevention drugs was valued at approximately $250 million in 2022 and is projected to reach $400 million by 2027, growing at a compound annual growth rate (CAGR) of 9.4%.[1] MAKENA holds a significant share within this niche, primarily in North America, where its FDA approval confers exclusivity.

Pricing and Reimbursement:

MAKENA is priced at approximately $1,200 to $1,350 per injection in the U.S., with treatment typically involving weekly injections from the second trimester until approximately 36 weeks. Reimbursement coverage varies; Medicaid programs generally cover MAKENA, supporting its adoption rate in the U.S.

Market Adoption Trends:

• Increased awareness of preterm birth risks has elevated demand.
• Competition from off-label compounded hydroxyprogesterone formulations exists but lacks FDA approval for prophylactic use.
• Due to high injection costs and reimbursement complexities, uptake remains cautious among providers and payers.

Competitor Analysis:

Drug/Agent	Development Stage	Market Position	Key Attributes
Makena (hydroxyprogesterone caproate)	Approved (2011)	Market leader in U.S. preterm birth prevention	FDA-approved, branded, high cost
Compounded Hydroxyprogesterone	Off-label	Limited by lack of FDA approval	Lower cost but regulatory risks
New Candidates	Clinical stages	Emerging therapies (beta-adrenergic antagonists, cerclage adjuncts)	Not yet impacting market share

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What are the future projections for MAKENA’s market?

Market Growth Dynamics:

Despite the lack of recent clinical trial activity, the market for preterm birth prevention is expected to grow due to increasing preterm birth rates globally, driven by factors such as maternal age and chronic disease prevalence.[2]

Forecasts estimate MAKENA's market share to decline slightly due to:

• The entry of generics and compounded formulations causing price erosion.
• Possible loss of exclusivity if patents expire or if new regulatory barriers emerge.

Revenue Projections:

• The current annual revenue for MAKENA in the U.S. exceeds $300 million.
• Potential decline of 10%-15% over the next 3-5 years if generic competition increases.
• Continued demand in high-risk populations supports sustained low-double-digit revenue.

Regulatory Outlook:

MAKENA's patent protection is set to expire by 2026, raising potential for generic formulations. The generic market entry could lead to a revenue reduction unless the brand sustains differentiation through new indications or formulations.

Pipeline and Innovation Outlook:

• No substantial pipeline for MAKENA-specific formulations exists.
• Some companies are focusing on alternative approaches, such as cervical cerclage devices and novel biologics, which might reduce reliance on hydroxyprogesterone caproate.

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Key Takeaways

• MAKENA has maintained a stable market position since its FDA approval in 2011, with no recent Phase III trials; focus remains on post-market surveillance.
• The drug faces market pressure from off-label compounded products and upcoming patent expirations, which threaten revenue.
• Global preterm birth prevention market is growing, but MAKENA's market share may decline due to increased competition.
• Regulatory and reimbursement factors significantly influence market dynamics; high treatment costs are a barrier to broader adoption.

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FAQs

1. Are there ongoing clinical trials for MAKENA?
No recent or ongoing clinical trials for MAKENA itself are publicly reported. Current activities focus on safety registries and post-market studies.

2. When will generic versions of MAKENA likely enter the market?
Patent exclusivity is expected to expire by 2026, paving the way for generics, which could reduce branded drug revenues significantly.

3. Are there alternative drugs for preterm birth prevention?
Yes. Progesterone suppositories and vaginal gels are alternatives, though they lack the FDA approval that MAKENA has, and their efficacy varies.

4. How does price influence MAKENA’s market penetration?
High cost per injection (~$1,200–$1,350) limits adoption, especially outside of covered Medicaid populations. Price reductions would be necessary for wider uptake.

5. What regulatory changes could impact MAKENA’s market?
Patent expiration and approval of generic competitors, along with changing reimbursement policies, pose the greatest regulatory risk.

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References

[1] MarketsandMarkets, Preterm Birth Prevention Market Report, 2022.
[2] World Health Organization, Preterm Birth Factsheet, 2023.
[3] U.S. FDA, MAKENA Approval Summary, 2011.