What Protara Therapeutics does

Protara Therapeutics, Inc. is a clinical-stage biotechnology company developing two investigational therapies for cancer and rare diseases with limited treatment options. The company's lead asset, TARA-002, is a cell-based immunotherapy developed from the same Streptococcus pyogenes master cell bank as OK-432 (Picibanil) — an immunopotentiator approved in Japan and Taiwan for multiple oncologic indications and lymphatic malformations. TARA-002 is being evaluated in U.S. clinical trials for non-muscle invasive bladder cancer (NMIBC), including BCG-unresponsive and BCG-naïve populations, and for pediatric macrocystic and mixed cystic lymphatic malformations. The second asset, IV Choline Chloride, is an investigational intravenous phospholipid substrate replacement therapy targeting choline deficiency in patients on long-term parenteral support, where approximately 80% of long-term PS patients are choline deficient and no FDA-approved IV choline formulation currently exists.

The company's addressable patient populations include approximately 84,000 people newly diagnosed with bladder cancer annually in the U.S. (with NMIBC representing roughly 75% of diagnoses, or ~65,000 cases), a pediatric lymphatic malformation population with no approved therapies, and approximately 30,000 U.S. patients on long-term parenteral support. The combined NMIBC market in the 7MM was estimated by DelveInsight at approximately $3 billion in 2025 with 1.56 million prevalent cases. Protara's products have received multiple FDA designations including Breakthrough Therapy, Rare Pediatric Disease, Fast Track, and Orphan Drug for TARA-002 in lymphatic malformations, and Orphan Drug plus Fast Track for IV Choline Chloride, with patents on the choline composition and method of treatment extending to 2041.

Protara is a pre-revenue company that does not currently sell any approved product and generates no licensing or collaboration revenue. Its go-to-market approach centers on completing Phase 2 and Phase 2b/3 clinical trials (ADVANCED-2, ADVANCED-3, STARBORN-1, THRIVE-3), pursuing regulatory approvals, and building a U.S. commercial organization in advance of launch. The company presents at scientific conferences (ASCO, EHA, Society of Urologic Oncology) and engages investors through virtual fireside chats and SEC filings. Founded in 2017 by Jesse Shefferman and Jacqueline Zummo, Protara listed on NASDAQ under ticker TARA in early 2020 and is headquartered in New York City's Flatiron District.

Name

Protara Therapeutics

Legal name

Protara Therapeutics, Inc.

Website

https://protaratx.com

Company type

Public

Founded year

2017

Operating status

Operating

Headcount range

11–50 employees

Short description

Protara Therapeutics is a clinical-stage biotechnology company developing TARA-002, an OK-432-based cell therapy for non-muscle invasive bladder cancer and pediatric lymphatic malformations, and IV Choline Chloride for choline deficiency in long-term parenteral support patients.

Ownership category

akta.pro rank

Product category

Clinical-stage Biopharmaceuticals

NAICS

Biological Product (except Diagnostic) Manufacturing (325414), Research and Development in Biotechnology (except Nanobiotechnology) (541714)

SIC

Pharmaceutical Preparations (2834), Biological Products, (No Disgnostic Substances) (2836)

akta.pro primary industry

Nephrology & Urology Specialty Pharmaceuticals (HLAIACAH)

akta.pro secondary industry

Gastroenterology Specialty Pharmaceuticals (HLAIACAE)

Keywords

• Cell therapy oncology
• Rare disease therapeutics
• Bladder cancer treatment
• Parenteral nutrition therapy
• Clinical stage biopharmaceuticals

Headquarters

HQ city

New York

HQ country

United States

HQ region

North America

Offices1 record

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

Technology or R&D, Personnel, Operations, Marketing or Sales, Infrastructure

Revenue model

1. Pharmaceutical Product Revenue: Pre-revenue clinical stage company. Not yet commercialized. Future revenue expected from sale of TARA-002 and IV Choline Chloride upon regulatory approval.

Go-to-market motion2 records

Distribution channels1 record

Marketing channels6 records

Core offering

Protara Therapeutics is a clinical-stage biotechnology company developing two investigational therapies: TARA-002, an investigational cell-based immunotherapy derived from the same master cell bank of Streptococcus pyogenes as OK-432 (Picibanil), being developed for non-muscle invasive bladder cancer (NMIBC) and pediatric lymphatic malformations; and IV Choline Chloride, an investigational intravenous phospholipid substrate replacement therapy designed to address choline deficiency in patients receiving long-term parenteral support. Both products are pre-commercial and currently advancing through Phase 2/2b/3 clinical trials with the intent of obtaining FDA approval.

Product overview

Protara Therapeutics is a clinical-stage biotechnology company developing a portfolio of therapies for cancer and rare diseases. The company has two lead investigational products: TARA-002, an immunopotentiator cell therapy derived from the same master cell bank as OK-432 (Picibanil), being developed for non-muscle invasive bladder cancer and lymphatic malformations; and IV Choline Chloride, an intravenous phospholipid replacement therapy for patients on parenteral support who are choline deficient.

Differentiator

Problem solved

Functional benefit

Products and services

• TARA-002 TARA-002 is an investigational cell-based immunotherapy developed from the same master cell bank of Streptococcus pyogenes as OK-432 (Picibanil). When administered, it activates innate and adaptive immune cells to produce pro-inflammatory cytokines (TNF-alpha, IFN-gamma, IL-1b, IL-6, IL-12, GM-CSF) and natural killer cells, directly killing tumor cells and triggering immunogenic cell death. It is being developed for the treatment of high-grade non-muscle invasive bladder cancer (NMIBC) in BCG-unresponsive and BCG-naive patients, and for macrocystic and mixed cystic lymphatic malformations in pediatric patients. The therapy has received FDA Rare Pediatric Disease, Breakthrough Therapy, Fast Track, and Orphan Drug designations.
• IV Choline Chloride IV Choline Chloride is an investigational intravenous phospholipid substrate replacement therapy for patients receiving parenteral support (PS) who are choline deficient. Choline is essential for phospholipid synthesis critical for healthy liver function and modulates gene expression, cell membrane signaling, brain development, neurotransmission, muscle function, and bone health. The therapy restores normal physiologic levels of choline to reverse steatosis by playing a role in VLDL synthesis to move fat out of the liver. It has the potential to become the first FDA-approved IV choline formulation for PS patients and is covered by U.S. patents claiming choline composition and methods for treating choline deficiency (expiring 2041), with FDA Orphan Drug and Fast Track designations.

Quantifiable outcome

• 68% complete response rate at 6 months in BCG-unresponsive NMIBC patients (ADVANCED-2 trial)
• +5 more outcomes

Named customers3 records

Segments3 records

Ideal customer profiles3 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature2 records

Partnerships

One partnership is on record.

• Chugai Pharmaceutical Co., Ltd.coreTechnology or IntegrationTARA-002 was developed from the same master cell bank of Streptococcus pyogenes as OK-432, which is marketed as Picibanil in Japan by Chugai Pharmaceutical. OK-432 is approved in Japan and Taiwan for multiple oncologic indications and lymphatic malformations.

Scale indicators9 records

Recent moves7 records

Expansion highlights5 records

Direct peers

• CG Oncology: Clinical-stage immuno-oncology company developing cretostimogene (an oncolytic adenovirus) for BCG-unresponsive NMIBC. Most directly comparable to Protara's TARA-002 program in patient population, indication, and mechanism class.
• ImmunityBio: Developed Anktiva (nogapendekin alfa), an IL-15 superagonist approved for BCG-unresponsive NMIBC. Directly competes with TARA-002 in the same indication with similar mechanism (intravesical immunotherapy).
• Ferring Pharmaceuticals: Markets Adstiladrin (nadofaragene firadenovec) for BCG-unresponsive NMIBC. Established bladder cancer franchise and competing directly with TARA-002 for the same patient population.

Broad incumbents

• Baxter International: Major manufacturer of parenteral nutrition products including IV lipid and amino acid solutions. Comparable to Protara's IV Choline Chloride program targeting choline-deficient parenteral support patients.
• Travere Therapeutics: Public clinical-stage biotech with a focus on rare disease and specialty therapeutics, including therapies with Orphan Drug and Breakthrough Therapy designations. Comparable business model and clinical-stage profile.
• BridgeBio Pharma: Clinical-stage rare disease biotech with similar small-cap, multi-asset, FDA-designation-heavy profile. Comparable as a public clinical-stage rare disease platform developing transformative therapies.
• Merck & Co. Has Keytruda (pembrolizumab) approved for BCG-unresponsive NMIBC and broader bladder cancer portfolio. As a large incumbent in NMIBC and oncology broadly, competes with TARA-002 in the same indication.
• B. Braun Medical: Global manufacturer of parenteral nutrition solutions and IV pharmaceuticals. Relevant comparable for Protara's IV Choline Chloride parenteral support franchise from a commercialization and channel perspective.
• Johnson & Johnson: Markets Balversa (erdafitinib) for FGFR-altered bladder cancer and has a broad urology/oncology portfolio. Relevant incumbent competitor in bladder cancer treatment space.

Regional players

• Tara Biosystems (replaced conceptually by Chugai): Chugai Pharmaceutical markets Picibanil (OK-432) in Japan and Taiwan for lymphatic malformations and multiple oncologic indications — the originator compound from which TARA-002 is derived. Regional competitor with overlapping mechanism.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat3 records

Key risks6 records

Key highlights7 records

Customer concentration

• LinkedInlinkedin.com/company/protara-therapeutics

Compliance5 records

Revenue estimate

Valuation estimate

Number of profiles

Profiles9 records

Funding overview

Funding rounds5 records

Investors9 records

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A1 record

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about Protara Therapeutics