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TAVT-45 · 1 trial · 3 indications
The primary endpoint was the between group comparison of serum testosterone levels for the average of levels on Days 9 and 10 (rounded-up) for mCRPC patients.
| Arm | Type | Description |
|---|---|---|
| TAVT-45 | EXPERIMENTAL | TAVT-45 administered twice daily as a 1 x sachet containing TAVT-45 (250 mg abiraterone acetate) + Prednisone (5mg once or twice daily, depending on prostate cancer population). TAVT-45 administered approximately every 12 hours without respect to food. Patients treated for 84 days. |
| Reference abiraterone acetate (Zytiga®) - R-AA | ACTIVE_COMPARATOR | Zytiga (reference abiraterone acetate formulation, hereafter referred to as R-AA) administered once daily as (2 x 500mg Zytiga tablets) + Prednisone (5mg once or twice daily, depending on prostate cancer population). R-AA administered once daily either ≥ 1 hour before or ≥ 2 hours after a meal. Patients treated for 84 days. |
| Name | Type | Description |
|---|---|---|
| TAVT-45 | DRUG | 250 mg abiraterone acetate granules for oral suspension in a sachet, reconstituted in water or specified fruit juice (orange juice), administered twice daily. |
| Zytiga | DRUG | 500 mg tablet, two tablets administered once daily |
| Prednisone | DRUG | mCSPC patients received 5 mg orally once daily. mCRPC patients received 5 mg orally twice daily. |
Inclusion Criteria: 1. Written informed consent obtained prior to any study-related procedure being performed 2. Male patients at least 18 years of age or older at time of consent 3. Pathologically confirmed adenocarcinoma of the prostate 4. Ongoing therapy with a gonadotropin releasing hormone (Gn...
TAVT-45 is an investigational small molecule being developed for metastatic castration-resistant prostate cancer. It is a Phase 3 drug candidate studied in patients with metastatic prostate cancer, including castration-resistant and castration-sensitive forms. The drug is being developed by cbdMD, Inc. (YCBD) and is not yet approved by the FDA.
TAVT-45 is a small molecule that contains abiraterone acetate as its active ingredient. Abiraterone acetate works by inhibiting the enzyme CYP17, which is involved in androgen production. By blocking this enzyme, TAVT-45 reduces testosterone levels that can fuel prostate cancer growth. This mechanism is relevant for treating metastatic castration-resistant prostate cancer.
TAVT-45 is being developed by cbdMD, Inc., a company traded on the NYSE American under the ticker symbol YCBD. The company is conducting clinical trials to evaluate the drug for metastatic prostate cancer. As of the latest data, TAVT-45 is in Phase 3 clinical development.
TAVT-45 is in Phase 3 clinical development. It is an investigational drug and has not received FDA approval. The drug is being studied for metastatic castration-resistant prostate cancer and other metastatic prostate cancer conditions. One Phase 3 trial has been completed, with 107 patients enrolled.
TAVT-45 has one completed Phase 3 clinical trial, identified as NCT04887506. This trial, titled "TAVT-45 (Abiraterone Acetate) Granules in Patients With Prostate Cancer," enrolled 107 male patients aged 18 years and older. The study was conducted in multiple countries, including the United States, France, Hungary, Poland, Puerto Rico, Spain, Sweden, and the United Kingdom.
TAVT-45 is a formulation of abiraterone acetate, as indicated by the clinical trial title. It is being studied as granules for patients with prostate cancer. The drug is in Phase 3 development by cbdMD, Inc. (YCBD) for metastatic castration-resistant prostate cancer.