This section highlights FDA-related milestones and regulatory updates for drugs developed by Protara Therapeutics (TARA).
Over the past two years, Protara Therapeutics has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
TARA-002 and THRIVE-1. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
TARA-002 - FDA Regulatory Timeline and Events
TARA-002 is a drug developed by Protara Therapeutics for the following indication: Non-Muscle Invasive Bladder Cancer.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- TARA-002
- Announced Date:
- April 26, 2025
- Indication:
- Non-Muscle Invasive Bladder Cancer
Announcement
Protara Therapeutics, Inc. announced updated results from its ongoing Phase 2 open-label ADVANCED-2 trial assessing intravesical TARA-002, the Company's investigational cell-based therapy, in high-risk Non-Muscle Invasive Bladder Cancer (NMIBC) patients with carcinoma in situ, or CIS (± Ta/T1), who are Bacillus Calmette-Guérin (BCG)-Unresponsive or BCG-Naïve.
AI Summary
Protara Therapeutics announced updated results from its ongoing Phase 2 open-label ADVANCED-2 trial. The trial is testing TARA-002, an investigational cell-based therapy, in high-risk non-muscle invasive bladder cancer patients with carcinoma in situ (CIS) who are either Bacillus Calmette-Guérin (BCG)-Unresponsive or BCG-Naïve.
For the BCG-Unresponsive group, the complete response rate reached 100% at any time, with 67% maintaining a complete response at 12 months. In the BCG-Naïve group, 76% achieved a complete response at any time, with 43% sustaining it at 12 months. The therapy showed a favorable safety profile with no Grade 3 or higher treatment-related adverse events, and it was easily integrated into the current clinical workflow. The company plans to update the trial data at the end of 2025 with additional evaluable patients.
Read Announcement- Drug:
- TARA-002
- Announced Date:
- April 23, 2025
- Indication:
- Non-Muscle Invasive Bladder Cancer
Announcement
Protara Therapeutics announced it will host a conference call and live webcast at 8:30 a.m. ET on Monday, April 28, 2025, to review updated safety and efficacy data from the ongoing Phase 2 open-label ADVANCED-2 trial of TARA-002 in patients with non-muscle invasive bladder cancer (NMIBC), including data from patients who have reached the 12-month evaluation timepoint.
AI Summary
Protara Therapeutics, Inc. announced that it will host a conference call and live webcast at 8:30 a.m. ET on Monday, April 28, 2025. During the event, the company will review updated safety and efficacy data from its ongoing Phase 2 open-label ADVANCED-2 trial of TARA-002. This trial focuses on treating non-muscle invasive bladder cancer (NMIBC) and includes data from patients who have reached the 12-month evaluation timepoint.
The live session will provide an overview of how TARA-002 is performing in terms of safety and its potential effectiveness in reducing tumor activity. Participants can register to receive dial-in details for the conference call or follow the webcast on the company’s website, offering an interactive way to gain more insight into the trial’s progress.
Read Announcement- Drug:
- TARA-002
- Announced Date:
- April 10, 2025
- Indication:
- Non-Muscle Invasive Bladder Cancer
Announcement
Protara Therapeutics, Inc. announced that two presentations and a panel discussion highlighting the ongoing Phase 2 open-label ADVANCED-2 trial of TARA-002 in patients with non-muscle invasive bladder cancer (NMIBC) will be featured at the upcoming American Urological Association (AUA) 2025 Annual Meeting taking place from April 26, 2025 to April 29, 2025 in Las Vegas.
AI Summary
Protara Therapeutics, Inc. announced it will feature two presentations and a panel discussion on its Phase 2 open-label ADVANCED-2 trial at the American Urological Association (AUA) 2025 Annual Meeting in Las Vegas. The trial evaluates the investigational cell therapy TARA-002 in patients with non‐muscle invasive bladder cancer (NMIBC) who are either unresponsive or naïve to Bacillus Calmette-Guérin (BCG) therapy. One presentation will share preliminary results showing anti-tumor activity and safety data, while the other will further discuss safety and efficacy findings from the trial. Additionally, an interactive poster session on the updated data, including results from patients reaching the 12-month evaluation, is scheduled for Saturday, April 26, 2025. This program underlines Protara’s ongoing commitment to advancing innovative treatments for bladder cancer patients.
Read Announcement- Drug:
- TARA-002
- Announced Date:
- March 5, 2025
- Indication:
- Non-Muscle Invasive Bladder Cancer
Announcement
Protara Therapeutic provided a business update
AI Summary
Protara Therapeutics provided a business update outlining key milestones and progress across its development programs. The company reported positive six‐month data from its Phase 2 ADVANCED-2 trial of TARA-002 in patients with non-muscle invasive bladder cancer (NMIBC). CEO Jesse Shefferman emphasized that TARA-002 has shown promise as both a stand-alone treatment and in combination with other therapies. The company expects to share initial data from 12-month evaluable patients in the ADVANCED-2 trial by mid-2025. Protara is also preparing to start its pivotal THRIVE-3 trial of IV Choline Chloride for patients reliant on parenteral support in the first half of 2025, while an interim update from its Phase 2 STARBORN-1 trial in pediatric lymphatic malformations is anticipated by the end of the first half of 2025.
Additionally, the company reported robust financials, with $170 million in cash and investments as of December 31, 2024, supporting operations into 2027.
Read Announcement- Drug:
- TARA-002
- Announced Date:
- January 13, 2025
- Indication:
- Non-Muscle Invasive Bladder Cancer
Announcement
Protara Therapeutics, Inc. today highlighted recent updates and anticipated 2025 milestones.
AI Summary
Protara Therapeutics, Inc. recently shared updates on its upcoming milestones for 2025 while emphasizing its progress in developing new treatments for cancer and rare diseases. The company expects to report 12‐month data from its ADVANCED-2 trial of TARA-002 for non-muscle invasive bladder cancer by mid‑2025, following promising interim results from the six-month evaluable patients. In addition, a futility analysis for approximately 25 six‑month evaluable BCG-Unresponsive patients is anticipated by the end of 2025.
Protara also plans to initiate the pivotal THRIVE‑3 trial of IV Choline Chloride in the first half of next year, which aims to support patients on parenteral nutrition. Moreover, further data from the Phase 2 STARBORN‑1 trial of TARA‑002 in pediatric lymphatic malformations is expected by the end of the first half of 2025. The company’s recent successful financing has extended its operational runway into 2027.
Read Announcement - Drug:
- TARA-002
- Announced Date:
- December 5, 2024
- Indication:
- Non-Muscle Invasive Bladder Cancer
Announcement
Protara Therapeutics, Inc announced results from its ongoing Phase 2 open-label ADVANCED-2 trial. The trial is assessing intravesical TARA-002, the Company's investigational cell-based therapy, in high-risk Non-Muscle Invasive Bladder Cancer (NMIBC) patients with carcinoma in situ or CIS (± Ta/T1) who are Bacillus Calmette-Guérin (BCG)-Unresponsive or BCG-Naïve.
Read Announcement- Drug:
- TARA-002
- Announced Date:
- December 3, 2024
- Indication:
- Non-Muscle Invasive Bladder Cancer
Announcement
Protara Therapeutics, announced it will host a conference call and live webcast at 8:30 a.m. ET on Thursday, December 5, 2024, to review new data from an interim analysis of the ongoing Phase 2 open-label ADVANCED-2 trial of TARA-002 in patients with non-muscle invasive bladder cancer (NMIBC).
AI Summary
Protara Therapeutics announced that it will host a live conference call and webcast at 8:30 a.m. ET on December 5, 2024. During the call, the company will review new data from an interim analysis of the ongoing Phase 2 open-label ADVANCED-2 trial of its cell-based therapy, TARA-002, which is being tested for non-muscle invasive bladder cancer (NMIBC). This trial includes patients who have either not responded to or have never received Bacillus Calmette-Guérin (BCG) therapy.
The latest study results will also be highlighted during a poster session at the 25th Annual Meeting of the Society of Urologic Oncology later that day. Interested viewers are invited to register on the company’s website to participate in the live call or access the webcast, with a replay available for a limited time after the event.
Read Announcement- Drug:
- TARA-002
- Announced Date:
- April 5, 2024
- Estimated Event Date Range:
- July 1, 2024 - December 31, 2024
- Target Action Date:
- 2024-H2
- Indication:
- Non-Muscle Invasive Bladder Cancer
Announcement
Protara Therapeutics announced that Preliminary data from six-month evaluable patients in ADVANCED-2 trial of TARA-002 in NMIBC expected in 2H 2024
AI Summary
Protara Therapeutics recently announced promising clinical updates for TARA-002, an investigational cell-based therapy for high-risk non-muscle invasive bladder cancer (NMIBC). In its ongoing ADVANCED-2 Phase 2 trial, TARA-002 demonstrated encouraging three-month complete response rates in diverse patient groups, including those with carcinoma in situ (CIS) and patients who are BCG-unresponsive, BCG-experienced, or BCG-naïve. The therapy also exhibited a favorable safety and tolerability profile with no Grade 3 or higher treatment-related adverse events. Enrollment continues as the trial incorporates reinduction and maintenance dosing to potentially enhance response rates further. Importantly, Protara anticipates presenting preliminary data from six-month evaluable patients in the ADVANCED-2 trial during the second half of 2024. These upcoming findings could provide crucial insights into TARA-002’s potential role in offering new treatment options for NMIBC patients.
Read Announcement- Drug:
- TARA-002
- Announced Date:
- April 5, 2024
- Indication:
- Non-Muscle Invasive Bladder Cancer
Announcement
Protara Therapeutics, announced positive data from three-month evaluable carcinoma in situ (CIS) patients treated across its ongoing clinical program of TARA-002, the Company's investigational cell-based therapy, in high-risk Non-Muscle Invasive Bladder Cancer (NMIBC), including Bacillus Calmette-Guérin (BCG)-Unresponsive, BCG-Experienced and BCG-Naïve patient populations.
AI Summary
Protara Therapeutics shared positive three‐month data from its NMIBC clinical program with TARA-002, an investigational cell-based therapy aimed at treating high-risk non-muscle invasive bladder cancer. The results focused on carcinoma in situ (CIS) patients, including those who are BCG-Unresponsive, BCG-Experienced, and BCG-Naïve. In patients with CIS only, the complete response (CR) rate was 63%, while the overall CR rate across varying disease stages was 38%. These encouraging findings suggest that TARA-002 could benefit NMIBC patients who currently have limited treatment options. Researchers also noted a favorable safety profile, as no Grade 3 or higher treatment-related adverse events were observed. The study investigators believe that reinduction therapy could further enhance response rates, building on what is known from other immune therapies used for bladder cancer.
Read Announcement
THRIVE-1 - FDA Regulatory Timeline and Events
THRIVE-1 is a drug developed by Protara Therapeutics for the following indication: Evaluating the prevalence of choline deficiency and liver injury in patients dependent on parenteral support (PS).
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- THRIVE-1
- Announced Date:
- March 19, 2025
- Indication:
- Evaluating the prevalence of choline deficiency and liver injury in patients dependent on parenteral support (PS).
Announcement
Protara Therapeutics, Inc. announced that data from THRIVE-1, a prospective, observational study evaluating the prevalence of choline deficiency and liver injury in patients dependent on parenteral support (PS), will be featured during an oral session at the American Society for Parenteral and Enteral Nutrition (ASPEN) 2025 Nutrition Science & Practice Conference, taking place March 22 through March 25, 2025 in Columbus, Ohio.
AI Summary
Protara Therapeutics, Inc. announced that data from its THRIVE-1 study will be featured during an oral session at the ASPEN 2025 Nutrition Science & Practice Conference in Columbus, Ohio, from March 22 to 25, 2025. The THRIVE-1 study is a prospective, observational trial that examined the prevalence of choline deficiency and liver injury in patients who depend on parenteral support for nutrition.
The study found that 78% of patients were choline deficient, and 63% of those deficient showed signs of liver dysfunction. These findings highlight a significant unmet need for choline supplementation in this vulnerable group. Protara is developing an intravenous (IV) Choline Chloride formulation to address this gap, providing an alternative route for choline delivery when oral or enteral feeding is not an option.
Read Announcement- Drug:
- THRIVE-1
- Announced Date:
- September 9, 2024
- Estimated Event Date Range:
- January 1, 2025 - March 31, 2025
- Target Action Date:
- Q1 - 2025
- Indication:
- Evaluating the prevalence of choline deficiency and liver injury in patients dependent on parenteral support (PS).
Announcement
Protara Therapeutics, Inc announced that Company expects to dose first patient in pivotal PK trial for IV Choline Chloride in Q1 2025
AI Summary
Protara Therapeutics, Inc. announced that the company expects to dose the first patient in its pivotal pharmacokinetic trial for IV Choline Chloride in the first quarter of 2025. This investigational therapy is a phospholipid substrate replacement developed to help patients who depend on parenteral support. The upcoming trial is a significant step forward in Protara’s ongoing efforts to advance innovative treatments for serious conditions, aligning with its strategy to enhance therapeutic options. The clinical trial is designed to assess the drug’s metabolism and effectiveness, with the potential to provide a new treatment avenue for patients in need. Protara’s commitment to transforming patient care continues to be reflected in its robust research and development pipeline, and the company looks forward to sharing more insights as the trial progresses.
Read Announcement- Drug:
- THRIVE-1
- Announced Date:
- September 9, 2024
- Indication:
- Evaluating the prevalence of choline deficiency and liver injury in patients dependent on parenteral support (PS).
Announcement
Protara Therapeutics, Inc. announced the results of THRIVE-1, a prospective, observational study evaluating the prevalence of choline deficiency and liver injury in patients dependent on parenteral support (PS).
AI Summary
Protara Therapeutics, Inc. recently announced key results from its THRIVE-1 study—a prospective, observational project that assessed the prevalence of choline deficiency and liver injury among patients dependent on parenteral support. The study highlights that choline deficiency may be an underrecognized issue in this vulnerable population and underscores the potential link to liver injury, offering important insights for future treatment strategies.
The THRIVE-1 findings add to Protara’s robust pipeline, which also includes development of novel therapies such as TARA-002 for pediatric patients with lymphatic malformations. The company’s expanding research efforts aim to address unmet medical needs in rare diseases and complex conditions. Protara’s work reflects its commitment to improving patient outcomes by exploring innovative approaches to both therapeutic intervention and supportive care in medically challenging groups.
Read Announcement
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