Cystitis Clinical Trials Analysis 2025: Novel Antimicrobials, Non-antibiotic Preventives, and Local Delivery Strategies Targeting Recurrent and Resistant Disease | DelveInsight

DelveInsight's "Cystitis - Clinical Trials Analysis, 2025" reviews an active pipeline addressing both uncomplicated and complicated urinary tract infections (UTIs)/cystitis, with emphasis on recurrent cystitis and antimicrobial resistance. Developers are pursuing next-generation oral and bladder-instilled antimicrobials, vaccines and immunotherapies to prevent recurrence, and non-antibiotic strategies (microbiome modulation, bacteriophages, intravesical agents) to reduce antibiotic exposure and resistance selection.

Late-stage programs include novel oral antibiotics with optimized Gram-negative activity and improved urinary exposure designed to treat multidrug-resistant uropathogens while minimizing systemic toxicity. Parallel efforts focus on prophylaxis: bacterial lysate vaccines, UTI-specific vaccine candidates, and live biotherapeutic products aiming to restore a protective urogenital microbiome and lower recurrence rates. Device-oriented approaches-improved urinary catheters with anti-biofilm coatings and intravesical sustained-release formulations-are advancing to reduce catheter-associated cystitis and recurrent lower-tract infections.

Trials increasingly incorporate patient-reported outcomes (symptom resolution and quality of life), rapid pathogen-guided enrollment, and antimicrobial stewardship endpoints (time to clinical cure and need for rescue antibiotics). Combination strategies pairing short, targeted antibiotic courses with prophylactic microbiome or immunomodulatory therapies are common in Phase II/III programs, reflecting a shift toward prevention-plus-precision treatment for high-risk patients.

The clinical landscape includes academic networks, specialty biotech firms, and established pharma sponsors running randomized trials across uncomplicated recurrent cystitis, catheter-associated UTI, and complicated lower tract infections. Key near-term readouts from vaccine, bacteriophage, and novel oral antimicrobial trials will influence guideline updates and stewardship practices, shaping next-generation cystitis management.

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Key Takeaways from the Cystitis Pipeline Report
• DelveInsight's cystitis pipeline analysis depicts a strong space with 15+ active players working to develop 15+ pipeline drugs for cystitis treatment.
• The leading cystitis companies include Seikagaku Corporation, Lipella Pharmaceuticals, AlloVir, Ironwood Pharmaceuticals, Paratek Pharmaceuticals, Alivio Therapeutics, Vaneltix Pharma, Qu Biologics, Imbrium Therapeutics, MIRAE CELL BIO, and others are evaluating their lead assets to improve the cystitis treatment landscape.
• Key cystitis pipeline therapies in various stages of development include SI 722, Tacrolimus liposomal, Posoleucel, IW-3300, Omadacycline, IMB 150, VNX 002, QBECP, Sunobinop, MR-MC-01, and others.
• In October 2024, Iterum Therapeutics announced that the FDA approved its oral antibiotic, ORLYNVAH, for treating uncomplicated urinary tract infections (UTIs) in adult women who have limited oral antibacterial treatment options. The approval follows successful late-stage trials showing the drug's safety and efficacy. Orlynvah is expected to be commercially available by mid-2025. ​
• In June 2024, Orchid Pharma announced the launch of its new drug, Cefepime-Enmetazobactam, for treating complicated urinary tract infections (cUTI), hospital-acquired pneumonia (HAP), and ventilator-associated pneumonia (VAP). The company has partnered with Cipla Ltd for the distribution of this drug, which aims to address antimicrobial resistance by targeting resistant bacterial strains. ​

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Cystitis Overview
Cystitis is a urinary bladder infection classified as either uncomplicated or complicated. Uncomplicated cystitis commonly affects healthy, non-pregnant women, while complicated cystitis occurs in individuals with risk factors such as catheter use, structural abnormalities, or immune compromise, making treatment more challenging. Most cases are caused by Escherichia coli (E. coli), which ascends from the periurethral area to infect the bladder. Typical symptoms include painful urination, urgency, frequent urination, and suprapubic discomfort, though these may also signal other urological conditions like bladder cancer. Diagnosis usually involves urine analysis and, in some cases, imaging or cystoscopy to exclude other pathologies. Treatment primarily relies on antibiotics, but chronic or interstitial forms may require anti-inflammatory medications or, rarely, surgery. While generally manageable, complicated cystitis demands tailored interventions and specialized care.

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Cystitis Treatment Analysis: Drug Profile
SI-722: Seikagaku Corporation
SI-722 is an innovative chemical compound where a steroid is conjugated with chondroitin sulfate through Seikagaku's proprietary glycosaminoglycan modification technology and drug delivery systems. Although the Phase I/II clinical trial in the U.S. faced delays due to COVID-19, subject enrollment was completed in January 2021, and tolerability was confirmed. Seikagaku Corporation is now moving forward with the next phase of trials based on the collected data.

Tacrolimus Liposomal: Lipella Pharmaceuticals
Lipella Pharmaceuticals' lead product, LP-10, is designed for the treatment of hemorrhagic cystitis and is currently undergoing a Phase II multi-center clinical trial. Lipella has also received U.S. FDA Orphan Drug Designation for this product.

Posoleucel: AlloVir
Posoleucel is designed to provide critical bridging immunity during the period between conditioning and immune system reconstitution. By restoring immunity during severe immune compromise, posoleucel may significantly reduce or prevent virus-associated morbidity and mortality, improving patient outcomes. The drug is currently in Phase II development for treating hemorrhagic cystitis.

Learn more about the novel and emerging cystitis pipeline therapies @ https://www.delveinsight.com/report-store/cystitis-pipeline-insight?utm_source=openpr&utm_medium=pressrelease&utm_campaign=jpr

Cystitis Therapeutics Assessment
By Product Type
• Mono
• Combination
• Mono/Combination.

By Stage
• Late-stage products (Phase III)
• Mid-stage products (Phase II)
• Early-stage product (Phase I) along with the details of
• Pre-clinical and Discovery stage candidates
• Discontinued & Inactive candidates

By Route of Administration
• Intra-articular
• Intraocular
• Intrathecal
• Intravenous
• Ophthalmic
• Oral
• Parenteral
• Subcutaneous
• Topical
• Transdermal

By Molecule Type
• Oligonucleotide
• Peptide
• Small molecule

Scope of the Cystitis Pipeline Report
• Coverage: Global
• Key Cystitis Companies: Seikagaku Corporation, Lipella Pharmaceuticals, AlloVir, Ironwood Pharmaceuticals, Paratek Pharmaceuticals, Alivio Therapeutics, Vaneltix Pharma, Qu Biologics, Imbrium Therapeutics, MIRAE CELL BIO, and others.
• Key Cystitis Pipeline Therapies: SI 722, Tacrolimus liposomal, Posoleucel, IW-3300, Omadacycline, IMB 150, VNX 002, QBECP, Sunobinop, MR-MC-01, and others.

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Table of Contents
1. Introduction
2. Executive Summary
3. Cystitis Pipeline: Overview
4. Analytical Perspective In-depth Commercial Assessment
5. Cystitis Pipeline Therapeutics
6. Cystitis Pipeline: Late-Stage Products (Phase III)
7. Cystitis Pipeline: Mid-Stage Products (Phase II)
8. Cystitis Pipeline: Early Stage Products (Phase I)
9. Therapeutic Assessment
10. Inactive Products
11. Company-University Collaborations (Licensing/Partnering) Analysis
12. Key Companies
13. Key Products
14. Unmet Needs
15. Market Drivers and Barriers
16. Future Perspectives and Conclusion
17. Analyst Views
18. Appendix

Contact Us:
Jatin Vimal
jvimal@delveinsight.com
+14699457679
Healthcare Consulting
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This release was published on openPR.