This section highlights FDA-related milestones and regulatory updates for drugs developed by Lixte Biotechnology (LIXT).
Over the past two years, Lixte Biotechnology has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
LB-100 and LB100. 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.
LB-100 FDA Regulatory Timeline and Events
LB-100 is a drug developed by Lixte Biotechnology for the following indication: Myelodysplastic syndrome, soft tissue sarcomas, small cell lung cancer, and glioblastoma.
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:
- LB-100
- Announced Date:
- October 16, 2025
- Target Action Date:
- Q4 2025
- Estimated Target Date Range:
- October 1, 2025 - December 31, 2025
- Indication:
- Myelodysplastic syndrome, soft tissue sarcomas, small cell lung cancer, and glioblastoma
Announcement
LIXTE Biotechnology today outlined its fourth-quarter 2025 priorities and provided an update on its strategic business development and acquisition initiatives focused on oncology.
AI Summary
LIXTE Biotechnology today outlined its fourth-quarter 2025 priorities and provided an update on its strategic business development and acquisition initiatives focused on oncology. The company emphasized its commitment to advancing LB-100, a first-in-class inhibitor of protein phosphatase 2A (PP2A), in high-need cancer indications. LIXTE confirmed it is in advanced negotiations to acquire complementary oncology assets that could strengthen its pipeline and accelerate development, though it cautioned that no transaction is assured.
For clinical execution, LIXTE will continue progressing LB-100 studies in prioritized tumor settings, supported by growing preclinical and clinical data and collaborations with leading research centers. In oncology-focused expansion, the company is actively negotiating with partners to build a differentiated, multi-asset platform. Operational readiness initiatives in quality, chemistry-manufacturing-controls (CMC), and regulatory alignment are under way to ensure efficient study conduct and smooth integration of potential acquisitions.
LIXTE’s disciplined approach aims to create durable value for patients and shareholders by combining clinical momentum with targeted business development.
Read Announcement- Drug:
- LB-100
- Announced Date:
- March 31, 2025
- Indication:
- Myelodysplastic syndrome, soft tissue sarcomas, small cell lung cancer, and glioblastoma
Announcement
LIXTE Biotechnology announced it will conduct a new pre-clinical study in collaboration with Netherlands Cancer Institute (NKI) to test whether "initiated" cells that carry mutations found in cancer cells can be eliminated by treatment with LIXTE's proprietary compound LB-100.
AI Summary
LIXTE Biotechnology announced a new pre-clinical study in collaboration with the Netherlands Cancer Institute (NKI) to test whether its proprietary compound LB-100 can eliminate “initiated” cells—cells carrying mutations found in cancer. The study will use animal models to investigate if LB-100 can remove cells with a mutant RAS oncogene, which may accumulate as people age and could lead to cancer. This research aims to prevent the development of malignant cells before they form a reservoir of pre-cancerous cells.
Early clinical trials have shown that LB-100 is well-tolerated with minimal toxicity, making it a promising candidate for cancer prevention. Led by Dr. René Bernards, a leading figure in molecular carcinogenesis, the study could open new opportunities in cancer prevention by targeting cancer-initiating cells and reducing the overall risk of developing various cancers as individuals age.
Read Announcement- Drug:
- LB-100
- Announced Date:
- March 10, 2025
- Indication:
- Myelodysplastic syndrome, soft tissue sarcomas, small cell lung cancer, and glioblastoma
Announcement
LIXTE Biotechnology announced online publication of new pre-clinical data in BioXriv and International Journal of Pharmaceutics demonstrating how the Company's lead clinical compound, LB-100, is converted into its active form, endothall, a protein phosphatase (PP2A) inhibitor that has been found to be effective in cancer treatment in combination with immunotherapy.
AI Summary
LIXTE Biotechnology recently announced the online publication of new pre-clinical data in BioXriv and the International Journal of Pharmaceutics. The studies explain how the company’s lead clinical compound, LB-100, is converted into its active form, endothall. Endothall acts as a protein phosphatase (PP2A) inhibitor and is effective in fighting cancer when used with immunotherapy. One study, conducted at the Netherlands Cancer Institute, revealed that an enzyme speeds up LB-100’s conversion into endothall, suggesting this enzyme could be used as a biomarker to identify patients who might benefit most from the treatment. A separate study from BioPharmaWorks LLC showed that LB-100 can slowly convert into endothall through hydrolysis under normal conditions, but the enzymatic process is much quicker inside cells. These findings help clarify LB-100’s mode of action and may improve patient selection in clinical trials.
Read Announcement- Drug:
- LB-100
- Announced Date:
- September 4, 2024
- Indication:
- Myelodysplastic syndrome, soft tissue sarcomas, small cell lung cancer, and glioblastoma
Announcement
LIXTE Biotechnology announced it has received a Notice of Allowance from the United States Patent and Trademark Office (USPTO) for U.S. Patent application number 16/467,721, titled, "Oxabicycloheptanes for Modulation of Immune Response," for combining the Company's LB-100 compound with various innovative cancer immunotherapies.
AI Summary
LIXTE Biotechnology announced that it has received a Notice of Allowance from the USPTO for its patent application titled "Oxabicycloheptanes for Modulation of Immune Response." This patent covers the combination of the company’s LB-100 compound with various innovative cancer immunotherapies. The LB-100 compound acts as a PP2A inhibitor, and LIXTE believes its use in combination with cancer immunotherapies can enhance treatment effects. This approved patent strengthens the company’s intellectual property portfolio and supports its ongoing efforts to develop new cancer treatments.
The technology is part of LIXTE’s broader research to improve outcomes for cancer patients. Testing of this combination treatment is currently underway in clinical trials at institutions like the Netherlands Cancer Institute and MD Anderson Cancer Center, highlighting the company’s commitment to pioneering research and creating breakthrough therapies.
Read Announcement- Drug:
- LB-100
- Announced Date:
- August 26, 2024
- Indication:
- Myelodysplastic syndrome, soft tissue sarcomas, small cell lung cancer, and glioblastoma
Announcement
LIXTE Biotechnology announced the dosing of the first patient in a new clinical trial in collaboration with the Netherlands Cancer Institute (NKI) and supported by F.
AI Summary
LIXTE Biotechnology has begun dosing the first patient in a new clinical trial focused on treating unresponsive (MSI Low) metastatic colorectal cancer. The trial is conducted in collaboration with the Netherlands Cancer Institute (NKI) and is supported by F. Hoffmann-La Roche Ltd. In this study, LIXTE is providing its lead compound, LB‑100, while Roche is supplying atezolizumab (Tecentriq®), a PDL1 inhibitor, through its imCORE Network. This network brings together academic and industry partners worldwide to accelerate cancer immunotherapy research.
The goal of the trial is to offer an effective immunotherapy option to approximately 85 percent of colorectal cancer patients who have not responded well to traditional treatments. Medical oncologist Neeltje Steeghs, M.D., Ph.D., highlighted the potential of this therapy to improve patient outcomes, marking an important step in expanding treatment options for this challenging disease.
Read Announcement
LB100 FDA Regulatory Events
LB100 is a drug developed by Lixte Biotechnology for the following indication: For Ovarian and Colorectal cancers.
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:
- LB100
- Announced Date:
- July 9, 2025
- Indication:
- For Ovarian and Colorectal cancers
Announcement
LIXTE Biotechnology Holdings, Inc. announced that the medical journal Nature has published findings by a team of physician-scientists that validate LIXTE's ongoing clinical trials with its proprietary compound LB100 for Ovarian and Colorectal cancers (https://www.nature.com/articles/s41586-025-09203-8).
AI Summary
LIXTE Biotechnology Holdings, Inc. announced that the respected medical journal Nature has published research findings which support the company’s ongoing clinical trials of its proprietary drug, LB100. The study, conducted by a team of physician-scientists led by Dr. Amir Jazaeri at MD Anderson Cancer Center, highlights how targeting the PP2A pathway with LB100 can improve responses to immune checkpoint therapies in cancers such as ovarian and colorectal. The findings validate that tumors with specific mutations, which reduce PP2A activity, are more responsive to immunotherapy. This important validation backs LIXTE’s clinical trials and ongoing collaboration with major pharmaceutical companies, including partnerships with GSK and Roche, to test LB100 in combination with immunotherapy drugs for better treatment outcomes.
The study’s publication in Nature adds significant credibility to LB100’s potential as a novel cancer treatment approach.
Read Announcement
Free LIXT Stock Alerts