Tavanta’s portfolio connects proven pharmacology with patient-focused innovation, delivering better clinical outcomes and simpler treatment regimens. By leveraging proprietary formulation platforms, Tavanta addresses critical unmet needs in two key areas:

Colorectal (TAVT-119)

A first-in-class topical amlodipine gel for chronic anal fissure, designed to replace inconsistent compounded alternatives with a standardized, FDA-regulated treatment.

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Oncology (TAVT-45)

A Phase 3-validated oral suspension of abiraterone acetate for prostate cancer, optimized for patients with dysphagia and variable drug absorption.

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TAVT-119: Targeted Relief for Chronic Anal Fissure

Tavanta Therapeutics is advancing TAVT-119, a proprietary amlodipine besylate gel designed to break the cycle of pain and ischemia in chronic anal fissure—a condition affecting more than 700,000 diagnosed patients in the U.S. each year.

The Clinical Challenge

Anal fissures trigger internal sphincter spasms that reduce blood flow, preventing the tear from healing. This causes excruciating pain and significantly impairs quality of life. Current first-line pharmacologic treatments remain suboptimal:

  • Topical Nitrates (Rectiv®): Limited by poor adherence; up to 60% of patients experience debilitating headaches, resulting in high discontinuation rates.
  • Compounded CCBs: No calcium channel blocker (CCB) is currently FDA-approved for this indication. Physicians must rely on off-label compounded diltiazem or nifedipine, which often have inconsistent quality, variable potency, and limited insurance coverage.

TAVT-119: A New Standard of Care

TAVT-119 leverages amlodipine’s pharmacokinetic profile, a long-acting CCB, to achieve potent muscle relaxation and local vasodilation. Designed as a standardized, stable, and regulated alternative to compounded agents, TAVT-119 aims to provide:

  • Predictable Pain Management: Directly targeting moderate-to-severe pain.
  • Regulated Consistency: An FDA-cleared alternative to variable compounded formulations.
  • Enhanced Adherence: Optimizing the patient experience to ensure treatment completion.

If approved, TAVT-119 will be the first FDA-indicated calcium channel blocker for anal fissure management, offering a much-needed standardized therapy for patients and providers.

1 Davids JS, et al. Dis Colon Rectum. 2023; 66(2):190–199.

2 Wald A, et al. Am J Gastroenterol. 2021; 116(10):1987–2008.

3 RECTIV® (nitroglycerin) Ointment 0.4% – Prescribing Information.

4 Hyman NH, Cataldo PA. Dis Colon Rectum. 1999; 42(3):383–385.

5 Sellers S, Utian WH. Drugs. 2012; 72(16):2043–2050.

6 Shah M, et al. World J Gastroenterol. 2013; 19(34):5645–5650.

7 NORVASC® (amlodipine besylate) Tablets – Prescribing Information.

PROSTATE CANCER
TAVT-45: Optimized Delivery of Abiraterone for Advanced Prostate Cancer

Tavanta Therapeutics is developing TAVT-45, a novel oral suspension of abiraterone acetate designed to enhance the treatment experience for men with metastatic prostate cancer by resolving the physical and pharmacological limitations of existing therapies.

The Clinical Challenge

Abiraterone acetate is the global 1st-line standard of care for metastatic prostate cancer, with over 250,000 annual U.S. prescriptions. However, the original tablet formulation (Zytiga®) presents significant hurdles for an aging patient population:

  • Dysphagia (Swallowing Difficulty): Many oncology patients struggle with the “pill burden” of multiple large tablets, leading to stress and non-compliance.
  • Strict Fasting Requirements: Traditional tablets must be taken on an empty stomach to avoid unpredictable absorption spikes—a regimen difficult for patients to maintain.
  • High Exposure Variability: Inconsistent plasma concentrations can result in suboptimal hormonal responses and clinical outcomes.

TAVT-45: Precision Engineering for Patient-Centric Care

TAVT-45 is a sophisticated granular formulation that rapidly reconstitutes into a liquid. By optimizing the delivery of a proven 1st-line therapy, TAVT-45 provides:

  • Ease of Administration: A liquid format specifically designed for patients with dysphagia, ensuring they can access gold-standard treatment without difficulty.
  • Mealtime Flexibility: Significantly mitigates the “food effect,” allowing for dosing without regard to meals and simplifying the daily routine.
  • Consistent Bioavailability: Demonstrated a more predictable absorption profile in clinical studies, reducing exposure variability compared to the reference tablet.

Clinical Progress & Regulatory Path

TAVT-45 has successfully completed a pivotal Phase 3 trial, meeting its primary objective of demonstrating therapeutic equivalence to Zytiga® in patients with mCRPC and mCSPC. With a comparable safety profile confirmed, an NDA is currently under preparation to bring this essential, easy-to-swallow formulation to the global oncology market.

    1 NIH – National Cancer Institute. SEER Program Stat Facts: Prostate Cancer.

    2 ZYTIGA® (abiraterone acetate) – Prescribing Information.

    3 Carton E, et al. Eur J Cancer. 2017; 72:54–61.

    4 van Nuland M, et al. Prostate Cancer Prostatic Dis. 2020; 23(2):244–251.

    5 Frowen J, et al. Support Care Cancer. 2020; 28(3):1141–1150.

    6 Drumond N, Stegemann S. Pharmaceutics. 2020; 13(1):32.

    7 Tavanta Therapeutics Press Release. Positive Top-Line Results from Pivotal Phase 3 Trial of TAVT-45.