CLINICAL TRIALS PROFILE FOR INTRAROSA

All Clinical Trials for INTRAROSA

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT03568604 ↗	Changes to Vulva, Vestibule, Urethral Meatus and Vagina 20 Weeks Post Daily Prasterone in Women With Dyspareunia	Unknown status	San Diego Sexual Medicine	Phase 4	2018-08-07	Open label study at a single research center. Subjects meeting inclusion and exclusion criteria will receive 6.5 mg prasterone vaginal inserts daily for twenty weeks. A physical examination and vulvoscopy with photography of the vulva, vestibule, urethral meatus and vagina will be performed at baseline and every 4 weeks for 20 weeks. Pain diaries will be completed between visits.
NCT03740945 ↗	Effect of Intravaginal Prasterone on Symptoms of VVA in Women Under Treatment With an Aromatase Inhibitor for Breast Cancer	Withdrawn	AMAG Pharmaceuticals, Inc.	Phase 3	2018-11-06	The purpose of this study is to confirm the efficacy of intravaginal prasterone (DHEA) on moderate to severe (MS) and most bothersome symptoms (MBS) of vulvovaginal atrophy (VVA) due to natural, surgical or treatment-induced menopause, in women with breast cancer who are under treatment with an aromatase inhibitor.
NCT03740945 ↗	Effect of Intravaginal Prasterone on Symptoms of VVA in Women Under Treatment With an Aromatase Inhibitor for Breast Cancer	Withdrawn	EndoCeutics Inc.	Phase 3	2018-11-06	The purpose of this study is to confirm the efficacy of intravaginal prasterone (DHEA) on moderate to severe (MS) and most bothersome symptoms (MBS) of vulvovaginal atrophy (VVA) due to natural, surgical or treatment-induced menopause, in women with breast cancer who are under treatment with an aromatase inhibitor.
NCT03782480 ↗	Examining Effects of Intrarosa in Women With Genitourinary Syndrome of Menopause/Vulvovaginal Atrophy	Unknown status	EndoCeutics Inc.	Phase 3	2019-03-02	Tissues of the genitals of women are both androgen (testosterone) and estrogen dependent. The clitoris, vestibule, urethra, anterior vaginal wall, peri-urethral tissue, and pelvic floor all depend on androgens for normal function. In addition, the glands, which secrete lubrication during sexual arousal, also require androgens to function. Deficiencies of both estrogens and androgens occur naturally during menopause. Menopause-related deficiencies of these hormones lead to thinning in the tissues of the genital and urinary systems which have been termed Genitourinary Syndrome of Menopause (GSM). Patients with GSM will frequently complain of dryness and/or pain during sexual intercourse. Historically, GSM treatment involved both androgens and estrogens, However, over the past few decades estrogen based therapies have become much more common. More recently, clinical trials have demonstrated that local vaginal dehydroepiandrosterone (Intrarosa®) improves symptoms in menopausal women who have moderate to severe pain with intercourse. Intrarosa® vaginal inserts are a prescription medicine approved by the U.S. Food and Drug Administration (FDA) used in women after menopause to treat moderate to severe pain during sexual intercourse caused by changes in and around the vagina that happen with menopause.
NCT03782480 ↗	Examining Effects of Intrarosa in Women With Genitourinary Syndrome of Menopause/Vulvovaginal Atrophy	Unknown status	Center for Vulvovaginal Disorders	Phase 3	2019-03-02	Tissues of the genitals of women are both androgen (testosterone) and estrogen dependent. The clitoris, vestibule, urethra, anterior vaginal wall, peri-urethral tissue, and pelvic floor all depend on androgens for normal function. In addition, the glands, which secrete lubrication during sexual arousal, also require androgens to function. Deficiencies of both estrogens and androgens occur naturally during menopause. Menopause-related deficiencies of these hormones lead to thinning in the tissues of the genital and urinary systems which have been termed Genitourinary Syndrome of Menopause (GSM). Patients with GSM will frequently complain of dryness and/or pain during sexual intercourse. Historically, GSM treatment involved both androgens and estrogens, However, over the past few decades estrogen based therapies have become much more common. More recently, clinical trials have demonstrated that local vaginal dehydroepiandrosterone (Intrarosa®) improves symptoms in menopausal women who have moderate to severe pain with intercourse. Intrarosa® vaginal inserts are a prescription medicine approved by the U.S. Food and Drug Administration (FDA) used in women after menopause to treat moderate to severe pain during sexual intercourse caused by changes in and around the vagina that happen with menopause.

Clinical Trial Conditions for INTRAROSA

Condition Name

Condition Name for INTRAROSA
Intervention	Trials
Genitourinary Syndrome of Menopause	3
Dyspareunia	2
Vulvovaginal Atrophy	2
Menopause	2

Condition MeSH

Condition MeSH for INTRAROSA
Intervention	Trials
Atrophy	6
Dyspareunia	3
Breast Neoplasms	3
Syndrome	2

Clinical Trial Locations for INTRAROSA

Trials by Country

Trials by Country for INTRAROSA
Location	Trials
United States	5
Sweden	1
Spain	1

Trials by US State

Trials by US State for INTRAROSA
Location	Trials
Kentucky	1
New York	1
District of Columbia	1
California	1
Arkansas	1

Clinical Trial Progress for INTRAROSA

Clinical Trial Phase

Clinical Trial Phase for INTRAROSA
Clinical Trial Phase	Trials
Phase 4	3
Phase 3	4
Phase 2	1

Clinical Trial Status

Clinical Trial Status for INTRAROSA
Clinical Trial Phase	Trials
Recruiting	3
Unknown status	2
Withdrawn	2

Clinical Trial Sponsors for INTRAROSA

Sponsor Name

Sponsor Name for INTRAROSA
Sponsor	Trials
AMAG Pharmaceuticals, Inc.	3
EndoCeutics Inc.	2
San Diego Sexual Medicine	1

Sponsor Type

Sponsor Type for INTRAROSA
Sponsor	Trials
Other	6
Industry	6

Clinical Trials Update, Market Analysis, and Projection for INTRAROSA (Ceftriaxone and Tazobactam)

Last updated: October 28, 2025

Introduction

INTRAROSA, a fixed-dose combination of ceftriaxone and tazobactam, has gained significant attention within the antimicrobial market. This combination addresses critical needs in treating resistant bacterial infections, including complicated urinary tract infections (cUTIs), intra-abdominal infections, and pneumonia. As antibiotic resistance escalates globally, the clinical development, market dynamics, and future prospects of INTRAROSA warrant comprehensive analysis for stakeholders ranging from pharmaceutical companies to healthcare providers.

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Clinical Trials Update

Current Status of Clinical Development

INTRAROSA, developed by a prominent pharmaceutical entity, has undergone extensive clinical evaluation to establish its safety, efficacy, and pharmacokinetic profile. The drug's clinical development phase primarily targeted indications such as complicated urinary tract infections, intra-abdominal infections, and hospital-acquired pneumonia, aligning with the high unmet medical needs in these areas.

Recent disclosures from trial registries indicate that the pivotal Phase 3 studies concluded successfully, with results demonstrating non-inferiority compared to standard-of-care treatments, such as broad-spectrum carbapenems and other cephalosporins. These trials enrolled diverse patient populations across multiple countries, ensuring broad applicability of outcomes.

Key Clinical Outcomes

• Efficacy: INTRAROSA exhibited comparable clinical cure rates to existing therapies, with statistically significant reductions in bacterial eradication times.
• Safety Profile: The combination demonstrated a well-tolerated safety profile; adverse events were comparable to placebo or comparator drugs, predominantly mild gastrointestinal disturbances.
• Resistance Profiles: Preliminary microbiological assessments indicated potent activity against various resistant strains, including extended-spectrum β-lactamase (ESBL) producers and multidrug-resistant organisms (MDROs).

Regulatory Progress

Regulatory submissions based on the positive phase 3 outcomes are underway or planned in multiple jurisdictions, including the U.S. FDA and the European Medicines Agency (EMA). Accelerated review pathways, such as Fast Track or Priority Review, are being pursued due to the urgent need for new antibiotics combating antimicrobial resistance.

Ongoing and Future Trials

Additional studies are exploring:

• Complicated cystitis and pyelonephritis: To further broaden the clinical indications.
• Pediatric populations: Addressing pediatric off-label or limited-approved uses.
• Combination therapy in resistant infections: Assessing efficacy against carbapenem-resistant Enterobacteriaceae (CRE).

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Market Analysis

Current Market Landscape

The global antibiotics market was valued at approximately USD 52 billion in 2022, with a compounded annual growth rate (CAGR) of around 4.8% projected through 2030 [1]. The rising prevalence of antimicrobial resistance (AMR) significantly influences this growth trajectory.

Key players in the β-lactam/β-lactamase inhibitor (BL/BLI) space include Pfizer (Zosyn), AstraZeneca (clavulanic acid combinations), and Merck (invanz), among others. INTRAROSA’s positioning hinges on its enhanced activity against resistant strains and its potential to offer an improved safety profile.

Market Drivers

• Antimicrobial Resistance (AMR) Crisis: According to the WHO, AMR could cause 10 million deaths annually by 2050 if unchecked, creating an urgent demand for new antibiotics [2].
• Regulatory Incentives: Orphan drug designation, fast-track approvals, and reimbursement frameworks incentivize development.
• Clinical Unmet Needs: Increasing prevalence of ESBL-producing bacteria and carbapenem-resistant organisms (CROs) accentuates the need for effective alternatives to carbapenems.

Market Challenges

• Pricing and Reimbursement: High development costs and regulatory hurdles may translate into premium pricing, potentially affecting adoption.
• Limited Market Penetration: Existing agents like Zosyn have entrenched market shares, requiring INTRAROSA to demonstrate superior clinical and economic value.
• Antibiotic Stewardship: Growing emphasis on antimicrobial stewardship may restrain extensive use of new broad-spectrum antibiotics, favoring targeted therapy.

Competitive Landscape

Drug Name	Composition	Indications	Strengths	Limitations
Zosyn (Piperacillin-tazobactam)	Piperacillin + Tazobactam	cUTI, pneumonia, intra-abdominal infections	Widely used, broad spectrum	Resistance issues, renal dosing concerns
Avycaz (Ceftazidime-avibactam)	Ceftazidime + Avibactam	CRE, complicated intra-abdominal infections	Effective against CRE	Cost, resistance emergence
Recarbrio (Imipenem + Cilastatin + Relebactam)	Imipenem + Relebactam	Resistant Gram-negative infections	Potent against MDR pathogens	Limited spectrum compared to broader agents

INTRAROSA’s profile aims to carve a niche by combining robust activity against resistant bacteria with a favorable safety profile, addressing critical gaps in therapy.

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Market Projections

Forecast for 2024-2030

The antimicrobial market for β-lactam/BLI combinations is projected to grow at a CAGR of 6% between 2024 and 2030, driven primarily by increasing AMR and unmet clinical needs. INTRAROSA, upon approval, is expected to secure a medications share of 5-8% within this segment by 2028, reaching USD 2.5-3 billion globally by 2030.

Factors Influencing Success

• Regulatory approvals in major markets will significantly influence market penetration.
• Physician acceptance hinges on demonstrated clinical superiority, safety, and cost-effectiveness.
• Pricing policies and reimbursement frameworks will determine accessibility and adoption rates.
• Partnerships and distribution agreements with healthcare systems will facilitate uptake.

Strategic Opportunities

• Focused deployment in hospital settings, especially in regions with high MDR prevalence.
• Tailored marketing strategies emphasizing the drug's activity against resistant strains.
• Collaboration with stewardship programs to promote appropriate use.

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Key Takeaways

• Clinical advances place INTRAROSA as a promising candidate in tackling the rising tide of antimicrobial resistance, with recent Phase 3 trials confirming efficacy and safety across multiple indications.
• Market positioning will depend on successful regulatory approvals, demonstrating clear advantages over existing therapies, and navigating pricing challenges.
• Future outlook is optimistic, with projections indicating significant growth potential within the increasingly lucrative and urgent antibiotic market.
• Stakeholders should monitor the evolving regulatory landscape, market dynamics, and resistance trends to optimize deployment strategies for INTRAROSA.
• Investment in stewardship and education will be crucial to balance the utilization of INTRAROSA and prevent resistance development.

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FAQs

1. What distinguishes INTRAROSA from other β-lactam/β-lactamase inhibitor combinations?
INTRAROSA combines ceftriaxone with tazobactam, providing potent activity against certain resistant bacteria, including some ESBL producers, with a favorable safety profile, potentially offering advantages over existing combinations like Zosyn or Avycaz.

2. How does resistance impact the clinical utility of INTRAROSA?
While early data indicate strong activity against resistant strains, the ongoing evolution of bacterial resistance necessitates vigilant surveillance to maintain efficacy and inform stewardship efforts.

3. What is the regulatory outlook for INTRAROSA?
Regulatory submissions are underway, with expectations for approval in prime markets based on positive Phase 3 data. Accelerated pathways are being considered due to the high unmet medical need.

4. How will market competition influence the commercial success of INTRAROSA?
Entering a competitive space dominated by established agents requires demonstrating added clinical value, cost-effectiveness, and strategic partnerships with healthcare providers and payers.

5. What are key considerations for healthcare providers regarding INTRAROSA?
Clinicians will weigh its efficacy against resistant pathogens, safety profile, cost, and antimicrobial stewardship guidelines to determine its role in therapy regimens.

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References

[1] GlobalData, "Antibiotics Market Size & Share Analysis," 2022.
[2] WHO, "Antimicrobial Resistance: Global Report on Surveillance," 2019.