This section highlights FDA-related milestones and regulatory updates for drugs developed by vTv Therapeutics (VTVT).
Over the past two years, vTv Therapeutics has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
Azeliragon and Cadisegliatin. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
Azeliragon - FDA Regulatory Timeline and Events
Azeliragon is a drug developed by vTv Therapeutics for the following indication: For the treatment of brain metastasis, metastatic pancreatic cancer, glioblastoma, and neoadjuvant therapy of breast 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:
- Azeliragon
- Announced Date:
- December 9, 2024
- Indication:
- For the treatment of brain metastasis, metastatic pancreatic cancer, glioblastoma, and neoadjuvant therapy of breast cancer.
Announcement
Cantex Pharmaceuticals, Inc., a announced today that the U.S. Food and Drug Administration (FDA) granted Orphan Drug Designation to Cantex's azeliragon for the treatment of brain metastasis from breast cancer.
AI Summary
Cantex Pharmaceuticals announced that the FDA has granted its azeliragon an Orphan Drug Designation for treating brain metastasis from breast cancer. This designation is an important milestone for the company, as it highlights the need for new treatment options in managing this life-threatening complication, particularly for aggressive subtypes like triple-negative breast cancer. Azeliragon works by inhibiting the receptor for advanced glycation end products (RAGE), a protein involved in cancer cell resistance to radiation, disease progression, and metastasis. The drug is well-tolerated, taken orally once a day, and represents a promising candidate in the fight against cancer spread to the brain. FDA Orphan Drug Designation provides benefits such as marketing exclusivity and support in the drug development process, reinforcing Cantex’s commitment to advancing innovative therapies for patients with limited treatment options.
Read Announcement- Drug:
- Azeliragon
- Announced Date:
- May 28, 2024
- Indication:
- For the treatment of brain metastasis, metastatic pancreatic cancer, glioblastoma, and neoadjuvant therapy of breast cancer.
Announcement
Cantex Pharmaceuticals announced today that Cantex's azeliragon, a well-tolerated once-a-day pill that inhibits "RAGE" (the receptor for advanced glycation end products), will be featured in four abstracts at this year's 2024 ASCO Annual Meeting to be held in Chicago.
AI Summary
Cantex Pharmaceuticals announced that its once-a-day pill, azeliragon, will be featured in four abstracts at the 2024 ASCO Annual Meeting in Chicago. Azeliragon works by blocking RAGE (the receptor for advanced glycation end products) and has shown a strong safety profile in studies of more than 2,000 individuals. The abstracts will cover research on azeliragon’s use in tough-to-treat cancers such as metastatic pancreatic cancer, newly diagnosed glioblastoma, early breast cancer, and brain metastases. This prominent placement at ASCO highlights ongoing clinical studies and the drug’s potential to change cancer treatment. Cantex’s CEO, Stephen G. Marcus, M.D., emphasized the opportunity the meeting provides to connect with top oncology researchers globally, as the company continues to advance clinical trials aimed at providing new hope for patients with life-threatening conditions.
Read Announcement- Drug:
- Azeliragon
- Announced Date:
- May 20, 2024
- Indication:
- For the treatment of brain metastasis, metastatic pancreatic cancer, glioblastoma, and neoadjuvant therapy of breast cancer.
Announcement
Cantex Pharmaceuticals, Inc. announced today that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation to Cantex' azeliragon, a well-tolerated once-a-day pill, for the treatment of pancreatic cancer.
Read Announcement
Cadisegliatin - FDA Regulatory Timeline and Events
Cadisegliatin is a drug developed by vTv Therapeutics for the following indication: For Type 1 Diabetes.
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:
- Cadisegliatin
- Announced Date:
- May 15, 2025
- Indication:
- For Type 1 Diabetes
Announcement
vTv Therapeutics Inc. announced that screening has been reinitiated in the Company's CATT1 Phase 3 trial investigating cadisegliatin as an adjunctive treatment of type 1 diabetes (T1D).
AI Summary
vTv Therapeutics Inc. has recently reinitiated screening in its CATT1 Phase 3 trial, which is exploring cadisegliatin as an adjunctive treatment for type 1 diabetes (T1D). The company amended the trial protocol to reduce its overall duration from 12 months to 6 months. This change is expected to speed up the collection of topline data and allow faster progress toward larger pivotal studies needed for a future New Drug Application submission.
The trial will evaluate the effectiveness and safety of cadisegliatin, an oral, liver-selective glucokinase activator that may help improve glycemic control by enhancing liver glucose uptake and glycogen storage. Continuous glucose monitors will be provided to all participants to track key outcomes, such as hypoglycemic events. Topline data from the trial are anticipated in the second half of 2026.
Read Announcement- Drug:
- Cadisegliatin
- Announced Date:
- March 20, 2025
- Indication:
- For Type 1 Diabetes
Announcement
vTv Therapeutics Inc. Provides Corporate Update
AI Summary
vTv Therapeutics Inc. recently provided a corporate update on its late-stage cadisegliatin program, offering new details on the upcoming Phase 3 CATT1 trial for type 1 diabetes. The company revealed plans to resume the trial in the second quarter of 2025, following a protocol amendment that reduces the trial duration from 12 months to 6 months. This change is designed to speed up the availability of topline data and allow pivotal studies to start sooner, without altering the study’s main endpoints.
Additionally, vTv Therapeutics has strengthened its commercial team with the appointment of Martin Lafontaine as Chief Commercial Officer. With over 27 years of experience in diabetes-related pharmaceuticals, Mr. Lafontaine’s leadership is expected to drive the advancement of the cadisegliatin program and support the company’s growth as it moves forward with its registrational efforts.
Read Announcement- Drug:
- Cadisegliatin
- Announced Date:
- March 17, 2025
- Indication:
- For Type 1 Diabetes
Announcement
vTv Therapeutics Inc. announced that the United States Food and Drug Administration (FDA) has lifted the clinical hold on the cadisegliatin clinical program, which includes the CATT1 Phase 3 trial in type 1 diabetes (T1D).
AI Summary
vTv Therapeutics Inc. announced that the FDA has lifted the clinical hold on its cadisegliatin program, which includes the CATT1 Phase 3 clinical trial in type 1 diabetes (T1D). The company plans to resume the trial after submitting a protocol amendment that shortens the study duration from 12 months to 6 months. This change is designed to speed up the process for obtaining topline data, ultimately helping to initiate larger pivotal Phase 3 studies needed for a future New Drug Application submission.
Cadisegliatin is an oral, liver-selective glucokinase activator being examined as a potential first-in-class oral adjunct therapy to insulin for T1D. With more than 500 subjects treated so far in previous studies, the treatment has shown promise and safety, further strengthening vTv’s commitment to advancing glycemic control and reducing hypoglycemia when used alongside insulin.
Read Announcement- Drug:
- Cadisegliatin
- Announced Date:
- July 26, 2024
- Indication:
- For Type 1 Diabetes
Announcement
vTv Therapeutics Inc. announced that the United States Food and Drug Administration (FDA) has placed a clinical hold on the cadisegliatin clinical program which includes the ongoing CATT1 Phase 3 trial in type 1 diabetes. Cadisegliatin is an oral, liver selective, glucokinase activator that has been well-tolerated in over 500 subjects to date with up to six months of treatment.
AI Summary
vTv Therapeutics Inc. announced that the FDA has placed a clinical hold on its cadisegliatin program, which includes the ongoing CATT1 Phase 3 trial for type 1 diabetes. This decision came after an unexpected chromatographic signal was detected in a recent human ADME study of cadisegliatin. The signal could not be explained with standard mass spectroscopy techniques, so the FDA requires an additional in vitro study to characterize it before the program can resume. Cadisegliatin, an oral, liver-selective glucokinase activator, has been well-tolerated in over 500 subjects with treatment durations of up to six months. No patients were dosed in the CATT1 trial at the time of the clinical hold. The company remains hopeful about the drug’s future after resolving the current issues.
Read Announcement- Drug:
- Cadisegliatin
- Announced Date:
- June 24, 2024
- Indication:
- For Type 1 Diabetes
Announcement
vTv Therapeutics Inc announced that the first patient has been screened in the Company's CATT1 pivotal trial evaluating cadisegliatin as an adjunct treatment of type 1 diabetes (T1D).
AI Summary
vTv Therapeutics Inc. recently made an important announcement for its cadisegliatin program. The company has screened the first patient in its CATT1 pivotal trial. This study is designed to evaluate the safety and effectiveness of cadisegliatin as an additional treatment for type 1 diabetes (T1D) alongside insulin. Cadisegliatin is a new, oral medication that works by activating liver glucokinase, a key enzyme in regulating blood sugar levels. The trial is a registrational study, aiming to gather the data needed for a future regulatory submission. Researchers hope that cadisegliatin will help improve blood sugar control and reduce hypoglycemic events, which are a common challenge for the nearly 8 million people living with T1D worldwide.
The initiation of the CATT1 trial marks a major milestone for vTv Therapeutics in its mission to deliver novel treatments for diabetes patients.
Read Announcement
