CLINICAL TRIALS

At Protara, we work tirelessly to accelerate the development of therapies for patients with cancer and rare diseases. Clinical studies are critical to the development and delivery of transformative therapies. At Protara, we advance our investigational therapies, TARA-002 and IV Choline Chloride, by continuing to study them in clinical trials designed to evaluate potential efficacy, safety, and tolerability.

TARA-002 in Non-Muscle Invasive Bladder Cancer (NMIBC)

TARA-002 is currently being studied in NMIBC patients with high-grade carcinoma in situ:

Disease
Phase
Study Focus
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High-Grade NMIBC

Phase 2

Open-label study to investigate the safety and anti-tumor activity of intravesical instillation of TARA-002 in adults 18 years of age or older with high-grade CIS (± Ta/T1) NMIBC who are BCG-unresponsive or BCG-naive.

Clinicaltrials.gov

TARA-002 in Lymphatic Malformations (LMs)

TARA-002 is currently being studied in a for the treatment of macrocystic and mixed cystic LMs in pediatric patients:

Disease
Phase
Study Focus
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Macrocystic and mixed cystic LMs

Phase 2a/b

Open-label study to evaluate the safety and efficacy of intracystic injection of TARA-002 in participants 6 months to less than 18 years of age for the treatment of macrocystic and mixed cystic lymphatic malformations.

Clinicaltrials.gov

Choline for Parenteral Support (PS) Patients

IV Choline Chloride is planned to be studied in adolescents and adults on long-term PS when oral or enteral nutrition is not possible, insufficient, or contraindicated:

Disease
Phase
Study Focus
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Long-term PS

Phase 2b/3

Seamless registrational trial with dose confirmation followed by a double-blinded, randomized, placebo-controlled trial in adolescents and adults receiving PS.
Initiating in first quarter of 2025
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