This section highlights FDA-related milestones and regulatory updates for drugs developed by TRACON Pharmaceuticals (TCON).
Over the past two years, TRACON Pharmaceuticals has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
Uliledlimab and TRC102. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
Select a button below to view the list of FDA events for that drug.
Uliledlimab (TJ004309) FDA Regulatory Events
Uliledlimab (TJ004309) is a drug developed by TRACON Pharmaceuticals for the following indication: Advanced 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:
- Uliledlimab (TJ004309)
- Announced Date:
- September 10, 2024
- Target Action Date:
- H1 2025
- Estimated Target Date Range:
- January 1, 2025 - June 30, 2025
- Indication:
- Advanced cancer
Announcement
I-Mab announced that Randomized Phase 2 study of uliledlimab in combination with pembrolizumab plus chemotherapy expected to begin in 1H 2025
AI Summary
I-Mab, a U.S.-based biotech company, announced plans for a randomized Phase 2 trial to evaluate uliledlimab in combination with pembrolizumab and chemotherapy for metastatic non‐small cell lung cancer (mNSCLC). The study is expected to begin in the first half of 2025. This trial builds on promising data from three Phase 1 studies, where pharmacokinetic/pharmacodynamic analyses showed that higher concentrations of uliledlimab were associated with improved overall response rates in mNSCLC patients. The data supported the dose selection strategy by demonstrating strong target engagement and achieving the desired drug exposure levels. I-Mab believes these findings reinforce the potential of uliledlimab to overcome immunosuppression in the tumor environment, paving the way for its next steps in clinical development and offering a promising new therapeutic option for patients with mNSCLC.
Read Announcement- Drug:
- Uliledlimab (TJ004309)
- Announced Date:
- September 10, 2024
- Indication:
- Advanced cancer
Announcement
I-Mab announced a poster presentation of PK/PD modeling data for uliledlimab at the International Association for the Study of Lung Disease (IASLD)'s 2024 World Conference on Lung Cancer (WCLC 2024) held September 7-10, 2024 in San Diego, CA.
AI Summary
I-Mab, a U.S.-based biotech company, has announced that it will present PK/PD modeling data for its CD73 inhibitor, uliledlimab (TJ004309), at the upcoming IASLD 2024 World Conference on Lung Cancer in San Diego, CA, from September 7-10, 2024. The poster presentation details analyses from three Phase 1 studies that provided key dosing insights to support future clinical trials. Notably, the Exposure-Response analysis showed a positive relationship between uliledlimab levels and overall response rates in patients with metastatic non-small cell lung cancer (mNSCLC).
The data also indicated strong target engagement with nearly complete CD73 receptor occupancy and demonstrated dose proportional pharmacokinetics. These positive findings have encouraged further development of uliledlimab as a promising, best-in-class CD73 inhibitor, with additional combination studies, including one with pembrolizumab and chemotherapy, planned to begin in the first half of 2025.
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TRC102 + Chemoradiation FDA Regulatory Events
TRC102 + Chemoradiation is a drug developed by TRACON Pharmaceuticals for the following indication: stage III Non-squamous Oon-small cell lung 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:
- TRC102 + Chemoradiation
- Announced Date:
- June 11, 2024
- Indication:
- stage III Non-squamous Oon-small cell lung cancer
Announcement
TRACON Pharmaceuticals announced the publication of Phase 2 clinical data of its DNA damage repair inhibitor drug candidate, TRC102, in patients with glioblastoma in Clinical Cancer Research.
AI Summary
TRACON Pharmaceuticals announced the publication of Phase 2 clinical data for its DNA damage repair inhibitor, TRC102, in the journal Clinical Cancer Research. This study evaluated the combination of TRC102 and Temozolomide (Temodar) in 19 patients with recurrent glioblastoma who had already undergone surgery, Temodar, and external beam radiotherapy. The findings highlighted that two patients experienced extended survival—with progression-free survival of at least 17 months and overall survival over 32 months. Both patients showed elevated signatures of DNA damage response, chromosomal instability, and cellular proliferation before starting the treatment, supporting the proposed mechanism of TRC102.
The results confirm the safety and potential benefit of combining TRC102 with Temodar for treating recurrent glioblastoma, encouraging further investigation in biomarker-enriched trials that target patients with highly active DNA damage response pathways.
Read Announcement
