Candidiasis Clinical Trials Analysis 2025: Oral Agents, Next-Generation Echinocandins, and Broad-Spectrum Antifungals Targeting Recurrent and Invasive Disease | DelveInsight

DelveInsight's "Candidiasis - Clinical Trials Analysis, 2025" examines an active clinical landscape addressing both mucosal (vulvovaginal) and invasive candidiasis. Unmet needs for safe, oral, and resistance-resilient therapies have driven the development of therapies across multiple modalities - new oral triterpenoids and azoles for recurrent vulvovaginal candidiasis (RVVC), next-generation echinocandins for candidemia/invasive candidiasis, and first-in-class broad-spectrum agents for drug-resistant and systemic infections. Regulatory progress and late-stage trials over the past few years have validated several novel approaches and accelerated the commercial availability of alternatives to legacy azoles.

Clinically meaningful approvals and label expansions have reshaped standards of care for mucosal candidiasis. BREXAFEMME (ibrexafungerp), an oral glucan synthase inhibitor, received FDA approval for vulvovaginal candidiasis (VVC) in June 2021 and later gained a second U.S. indication for reducing recurrences, bringing a non-azole oral option to outpatient care. Vivjoa (oteseconazole), a highly selective oral azole for recurrent VVC, was FDA-approved in April 2022 and has since been adopted as a targeted option for RVVC patients. For invasive disease, REZZAYO (rezafungin), a once-weekly next-generation echinocandin, received FDA approval in March 2023 for the treatment of candidemia and invasive candidiasis - providing a new dosing paradigm and supporting stewardship against resistant Candida species.

The clinical pipeline continues to advance with promising late-stage and registration-enabling programs. Fosmanogepix (the prodrug of manogepix), a first-in-class Gwt1 inhibitor with broad activity against Candida and molds, entered Phase III development for candidemia and invasive candidiasis in September 2024 - reflecting strong industry momentum toward novel mechanisms for treating difficult-to-treat systemic infections. Rezafungin's global Phase III ReSTORE program produced pivotal data supporting its approval and remains a benchmark for once-weekly echinocandin therapy. Several companies - including SCYNEXIS, Mycovia, Cidara/Mundipharma, and Basilea - are competing across indications from RVVC to bloodstream infections, making the next 24 months critical for approval readouts, label expansions, and real-world uptake.

Explore the full pipeline analysis for candidiasis and uncover key opportunities @ https://www.delveinsight.com/report-store/candidiasis-pipeline-insight?utm_source=openpr&utm_medium=pressrelease&utm_campaign=jpr

Key Takeaways from the Candidiasis Pipeline Report
• DelveInsight's candidiasis pipeline analysis depicts a strong space with 15+ active players working to develop 15+ pipeline drugs for Candidiasis treatment.
• The leading candidiasis companies include Cidara Therapeutics, MATINAS BIOPHARMA HOLDINGS, ProFem GmbH, CelaCare Technologies, Inc., SCYNEXIS, NovaDigm Therapeutics, NovaBiotics Ltd, Stadius Biopharma, Mycovia Pharmaceuticals, ORYN THERAPEUTICS, Biocidium Biopharmaceuticals, Hyloris Pharmaceuticals, and others are evaluating their lead assets to improve the Candidiasis treatment landscape.
• Key candidiasis pipeline therapies in various stages of development include Rezafungin, MAT2203, Prof-001, CelAgace, SCY 078, NDV 3, NP339, MSC Candida, VT-1598, BCM-0882, BCM-0915, MCZ-DB, and others.
• In May 2025, SCYNEXIS, Inc. announced the resumption of patient dosing in its Phase III MARIO study, evaluating oral ibrexafungerp as a step-down therapy after IV echinocandin for invasive candidiasis, a serious and life-threatening fungal infection.
• In March 2025, a novel antifungal drug, mandimycin, showed promising results against drug-resistant Candida species. The compound demonstrates a unique mechanism of action and low kidney toxicity, potentially offering a new option for treating severe fungal infections.
• In March 2025, the FDA approved DiaSorin Molecular's Simplexa® C. auris Direct assay, the first molecular test for detecting Candida auris DNA directly from skin swabs. This approval is expected to improve early diagnosis and infection control significantly.
• In March 2023, Cidara Therapeutics (Nasdaq: CDTX) and Melinta Therapeutics announced that the FDA approved REZZAYOTM (rezafungin for injection) for treating candidemia and invasive candidiasis in adults with limited treatment options. It is the first new treatment for these conditions in over a decade.

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Candidiasis Overview
Candidiasis is a fungal infection primarily caused by Candida albicans, a yeast that normally resides harmlessly in the body. However, when the immune system is weakened or the normal microbial balance is disrupted-due to factors like antibiotic use, chemotherapy, pregnancy, or diabetes-Candida can overgrow and lead to infection. It most commonly affects the skin, mouth (oral thrush), gut, and vagina, but in severe cases, especially in immunocompromised individuals, it can spread to the bloodstream (candidemia), heart, or brain, becoming potentially life-threatening. Symptoms range from localized irritation to severe systemic illness, depending on the severity and location of the infection.

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Candidiasis Treatment Analysis: Drug Profile
HRS9432: Jiangsu Hengrui Medicine
HRS9432 is a long-acting echinocandin antifungal developed to treat invasive fungal infections, especially invasive candidiasis. Early-stage clinical trials, including randomized, double-blind, dose-escalation studies in healthy volunteers, have demonstrated the drug's safety and tolerability, with mostly manageable side effects reported. HRS9432 is currently undergoing Phase II clinical development for candidiasis treatment.

MAT2203: Matinas Biopharma Holdings
MAT2203 is an oral, encochleated formulation of amphotericin B (CAmB) that uses Matinas BioPharma's proprietary lipid nanocrystal (LNC) technology. Designed to be non-toxic and systemically targeted, it offers broad-spectrum, fungicidal activity-killing fungi rather than merely inhibiting growth. MAT2203 delivers the drug directly to infection sites while minimizing systemic exposure and toxicity, making it a promising alternative for immunocompromised patients. The drug is currently in Phase II clinical trials for the treatment of candidiasis.

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

Candidiasis 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
• Inhalation
• Inhalation/Intravenous/Oral
• Intranasal
• Intravenous
• Intravenous/ Subcutaneous
• NA
• Oral
• Oral/intranasal/subcutaneous
• Parenteral
• Subcutaneous

By Molecule Type
• Antibody
• Antisense oligonucleotides
• Immunotherapy
• Monoclonal antibody
• Peptides
• Protein
• Recombinant protein
• Small molecule
• Stem Cell
• Vaccine

Scope of the Candidiasis Pipeline Report
• Coverage: Global
• Key Candidiasis Companies: Cidara Therapeutics, MATINAS BIOPHARMA HOLDINGS, ProFem GmbH, CelaCare Technologies, Inc., SCYNEXIS, NovaDigm Therapeutics, NovaBiotics Ltd, Stadius Biopharma, Mycovia Pharmaceuticals, ORYN THERAPEUTICS, Biocidium Biopharmaceuticals, Hyloris Pharmaceuticals, and others.
• Key Candidiasis Pipeline Therapies: Rezafungin, MAT2203, Prof-001, CelAgace, SCY 078, NDV 3, NP339, MSC Candida, VT-1598, BCM-0882, BCM-0915, MCZ-DB, and others.

Dive deep into rich insights for drugs used for candidiasis treatment; visit @ https://www.delveinsight.com/report-store/candidiasis-pipeline-insight?utm_source=openpr&utm_medium=pressrelease&utm_campaign=jpr

Table of Contents
1. Introduction
2. Executive Summary
3. Candidiasis Pipeline: Overview
4. Analytical Perspective In-depth Commercial Assessment
5. Candidiasis Pipeline Therapeutics
6. Candidiasis Pipeline: Late-Stage Products (Phase III)
7. Candidiasis Pipeline: Mid-Stage Products (Phase II)
8. Candidiasis 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
https://www.delveinsight.com/consulting-services

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This release was published on openPR.