Drugs / Sabizabulin
Sabizabulin
also known as
VERU-111 · ABI-231 · APP-111 · SABIZABULIN HYDROCHLORIDE · Sabizatbulin hydrochloride · VERU-111 hydrochloride
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Rejected (CRL) | US (FDA) | — | COVID-19 | — | “the FDA declined to grant at this time an Emergency Use Authorization (EUA) for sabizabulin for hospitalized COVID-19 patients” verupharma.com ↗ |
Trials 6
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT03752099 | Jan 2019 → Mar 2023 | castration-resistant prostate carcinoma | Veru Inc. | Terminated | No outcome recorded |
| Phase 23 trials · 1 met primary | ||||||
| Phase 2 | NCT05079360 | Mar 2023 → Mar 2024 | breast cancer | Veru Inc. | Withdrawn | No outcome recorded |
| Phase 2 | NCT05008510 | Dec 2021 → Jul 2022 | triple-negative breast carcinoma | Veru Inc. | Withdrawn | No outcome recorded |
| Phase 2 | NCT04388826 | Jun → Dec 2020 | adult acute respiratory distress syndrome | Veru Inc. | Completed | Met primary |
| Phase 32 trials · 1 met primary | ||||||
| Phase 3 | NCT04844749 | Jun 2021 → May 2023 | castration-resistant prostate carcinoma, hormone-resistant prostate carcinoma | Veru Inc. | Terminated | No outcome recorded |
| Phase 3 | NCT04842747 | May 2021 → Jul 2022 | COVID-19 | Veru Inc. | Completed | Met primary |
News releases announcing trial results or a regulatory action · 36
| Date | Issuer | Release |
|---|---|---|
| 2023-04-11 | Veru Inc. | Results Veru Announces Preclinical Study Results that Demonstrate Sabizabulin Inhibits Poxviruses verupharma.com ↗
Sabizabulin inhibited the cell release and cell-to-cell spread of poxvirus in a preclinical study |
| 2023-04-04 | Veru Inc. | Results Veru Announces Preclinical Results from Expanded Sabizabulin Program into Influenza-Induced Severe Acute Respiratory Distress Syndrome and Provides Update on COVID-19 Program verupharma.com ↗
Sabizabulin treatment resulted in a statistically significant decrease in the total number of inflammatory cells (-53%) (p<0.01) in BAL fluid, including statistically significant reductions in both the innate and adaptive immune cells. |
| 2023-03-02 | Veru Inc. | Regulatory Veru Provides FDA Update on Request for Emergency Use Authorization for Sabizabulin for Hospitalized COVID-19 Patients at High Risk for ARDS verupharma.com ↗
Veru Inc. (NASDAQ: VERU), a biopharmaceutical company focused on developing novel medicines for COVID-19 and other viral ARDS-related diseases and for oncology, today announced that the U.S. Food and Drug Administration (FDA) has declined to grant at this time the Company’s request for Emergency Use Authorization (EUA) for sabizabulin, Veru’s novel microtubule disruptor, to treat hospitalized adult patients with moderate to severe COVID-19 who are at high risk for Acute Respiratory Distress Syndrome (ARDS). |
| 2022-11-09 | Veru Inc. | Regulatory Veru Provides Update on FDA Advisory Committee Meeting Regarding Emergency Use Authorization of Sabizabulin to Treat Hospitalized COVID-19 Patients at High Risk for Acute Respiratory Distress Syndrome verupharma.com ↗
The advisory committee voted 8-5 that the known and potential benefits of sabizabulin when used for the treatment of adult patients hospitalized with COVID-19 at high risk of ARDS do not outweigh the known and potential risks of sabizabulin. |
| 2022-10-24 | Veru Inc. | Results Veru Announces Late-Breaker Oral Presentation of Sabizabulin Treatment for Hospitalized Adults with COVID-19 on Supplemental Oxygen at Infectious Disease Week 2022 verupharma.com ↗
We are excited to present positive clinical data from the pivotal Phase 3 COVID-19 study subset analysis of hospitalized COVID-19 patients who required supplemental oxygen and had at least one comorbidity. |
| 2022-09-07 | Veru Inc. | Regulatory Veru Announces Date for FDA Advisory Committee Meeting to Review Emergency Use Authorization for Sabizabulin for Hospitalized COVID-19 Patients at High Risk for Acute Respiratory Distress Syndrome verupharma.com ↗ |
| 2022-08-22 | Veru Inc. | Regulatory Veru Granted Expedited Provisional Registration Regulatory Pathway for Sabizabulin Treatment in Hospitalized COVID-19 Patients by Australia’s Therapeutic Goods Administration verupharma.com ↗
“We are pleased that another tier 1 regulatory agency, Australia’s Therapeutics Goods Administration, has determined that sabizabulin qualifies for an expedited regulatory review pathway for the treatment of hospitalized COVID-19 patients at high risk for ARDS,” |
| 2022-08-09 | Veru Inc. | Results Veru Announces Presentation of Phase 3 Study of Sabizabulin for the Treatment of Hospitalized COVID-19 Patients at High Risk for Acute Respiratory Distress Syndrome at the 11th International Conference on Emerging Infectious Diseases (ICEID) on August 7-10, 2022 verupharma.com ↗
For the primary endpoint which was all cause mortality by Day 60, a clinically meaningful and statistically significant 55.2% relative reduction in deaths was observed in the intent-to-treat population (p=0.0041). |
| 2022-07-27 | Veru Inc. | Regulatory European Medicines Agency’s Emergency Task Force Has Initiated the Review of Veru's Sabizabulin Treatment for Hospitalized COVID-19 Patients for Emergency Use in European Union Countries verupharma.com ↗ |
| 2022-07-25 | Veru Inc. | Regulatory UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) Supports Expedited Review of Marketing Authorization Application for Sabizabulin Treatment in Hospitalized COVID-19 Patients verupharma.com ↗
MIAMI, July 25, 2022 (GLOBE NEWSWIRE) -- Veru Inc. (NASDAQ: VERU), a biopharmaceutical company focused on developing novel medicines for COVID-19 and other viral and ARDS-related diseases and for the management of breast and prostate cancers, today announced that the United Kingdom’s (UK’s) Medicines and Healthcare Products Regulatory Agency (MHRA) considers that the currently available safety and efficacy data will support an expedited review of the marketing authorization application for the Company’s sabizabulin treatment in hospitalized COVID-19 patients at high risk for Acute Respiratory Distress Syndrome (ARDS) when the application is submitted. |
| 2022-07-06 | Veru Inc. | Results Veru Announces New England Journal of Medicine Evidence Publication of Phase 3 Clinical Trial Results Demonstrating that Sabizabulin Treatment Significantly Reduced Deaths in High-Risk Hospitalized COVID-19 Patients verupharma.com ↗ |
| 2022-06-07 | Veru Inc. | Regulatory Veru Submits Emergency Use Authorization (EUA) Application to U.S. FDA for Sabizabulin, its Novel, Oral Antiviral and Anti-Inflammatory Drug Candidate for Hospitalized COVID-19 Patients at High Risk for ARDS verupharma.com ↗
Veru Inc. (NASDAQ: VERU), a biopharmaceutical company focused on developing novel medicines for COVID-19 and other viral and ARDS-related diseases and for the management of breast and prostate cancers, today announced that is has submitted an emergency use authorization (EUA) application to the U.S. Food and Drug Administration for its sabizabulin oral 9mg treatment of moderate to severe hospitalized COVID-19 patients at high risk for developing Acute Respiratory Distress Syndrome (ARDS). |
| 2022-06-06 | Veru Inc. | Results Veru Announces Presentation of Final Positive Phase 1b/2 Clinical Trial Results for Sabizabulin in Metastatic Castration Resistant Prostate Cancer at the 2022 American Society of Clinical Oncology Annual Meeting verupharma.com ↗
Sabizabulin administration resulted in both cytotoxic and cytostatic anticancer activity with PSA declines and objective and durable tumor responses. |
| 2022-05-11 | Veru Inc. | Regulatory FDA States that Veru Should Submit Request for Emergency Use Authorization (EUA) Based on Positive Efficacy and Safety Data from the Phase 3 Clinical Study of Sabizabulin in Hospitalized COVID-19 Patients verupharma.com ↗
FDA agreed that the Phase 3 COVID-19 study that was stopped by the Independent Data Monitoring Committee for overwhelming efficacy is sufficient to support the efficacy portion of a request for EUA submission and for an NDA submission. |
| 2022-05-02 | Veru Inc. | Regulatory FDA Has Granted Veru a Pre-Emergency Use Authorization (EUA) Meeting Date for Positive Sabizabulin Phase 3 COVID-19 Study verupharma.com ↗
today announced that the FDA has granted the Company a pre-Emergency Use Authorization (EUA) meeting on May 10, 2022, for the positive Phase 3 COVID-19 study for sabizabulin. |
| 2022-04-25 | Veru Inc. | Results Veru Announces Oral Late-Breaking Presentation of Phase 2 Data of Sabizabulin for the Treatment of Hospitalized Severe COVID-19 Patients at High Risk for Acute Respiratory Distress Syndrome at the 32nd European Congress of Clinical Microbiology & Infectious Diseases verupharma.com ↗
We are very excited about the clinically meaningful reduction in deaths in hospitalized COVID-19 patients at high risk for ARDS and death being presented from this Phase 2 study. |
| 2022-04-11 | Veru Inc. | Results Veru’s Novel COVID-19 Drug Candidate Reduces Deaths by 55% in Hospitalized Patients in Interim Analysis of Phase 3 Study; Independent Data Monitoring Committee Halts Study Early for Overwhelming Efficacy verupharma.com ↗
The Independent Data Safety Monitoring Committee unanimously recommended that the Phase 3 study be halted early due to efficacy, and they further remarked that no safety concerns were identified. |
| 2022-02-17 | Veru Inc. | Results Veru Announces the Presentation of Updated Data from the Phase 1b/2 Sabizabulin Study in Men with Metastatic Castration Resistant Prostate Cancer at the 2022 ASCO Genitourinary Cancers Symposium verupharma.com ↗
For patients with measurable disease at baseline (n=29), the overall response rate was 20.7%. |
| 2022-01-31 | Veru Inc. | Regulatory Veru Announces FDA Grant of Fast Track Designation for Sabizabulin for the Treatment of Hospitalized COVID-19 Patients at High Risk for Acute Respiratory Distress Syndrome verupharma.com ↗ |
| 2021-09-20 | Veru Inc. | Results Veru Announces Positive Updated Data from Phase 1b/2 Sabizabulin Study in Men with Metastatic Castration Resistant Prostate Cancer at the 2021 ESMO Congress verupharma.com ↗
Sabizabulin was well tolerated with no clinically relevant neutropenia or neurotoxicity. |
| 2021-06-07 | Veru Inc. | Results Veru Announces Positive Phase 1b/2 Clinical Study Update for Sabizabulin (VERU-111) in Men with Metastatic Castration Resistant Prostate Cancer Presented at the 2021 ASCO Annual Meeting verupharma.com ↗
Sabizabulin oral daily dosing was well tolerated, and the most common adverse events, being mostly Grade 1 and 2, were diarrhea, fatigue, nausea, and decrease in appetite. |
| 2021-03-01 | Veru Inc. | Regulatory Veru Receives FDA Agreement to Advance VERU-111 into Phase 3 Study in Hospitalized COVID-19 Patients at High Risk for Acute Respiratory Distress Syndrome (ARDS) verupharma.com ↗
FDA agrees to advance VERU-111 into Phase 3 clinical study in hospitalized high risk COVID-19 patients to confirm the potential benefit and risk |
| 2021-02-10 | Veru Inc. | Results Veru Sets Another Quarterly Record in Both Net Revenues and in Gross Profit for Fiscal 2021 First Quarter verupharma.com ↗
Company Reports Positive Results from Phase 2 Clinical Trial Evaluating VERU-111 for the Treatment of Hospitalized COVID-19 Patients at High Risk for ARDS |
| 2021-02-08 | Veru Inc. | Results Veru Reports Positive Phase 2 Clinical Results of VERU-111 in Hospitalized COVID-19 Patients at High Risk for Acute Respiratory Distress Syndrome verupharma.com ↗
Primary efficacy endpoint in hospitalized patients shows VERU-111 treatment had statistically significant 81% relative reduction in death or respiratory failure at Day 29 |
| 2020-12-14 | Veru Inc. | Results VERU-111, Cytoskeleton Disruptor, Demonstrates Efficacy in Preclinical Models of Human Triple Negative Breast Cancer verupharma.com ↗
Veru Inc. (NASDAQ: VERU), an oncology biopharmaceutical company with a focus on developing novel medicines for the management of prostate and breast cancer, announces the presentation of preclinical data demonstrating the efficacy of oral VERU-111 in the treatment of human derived animal models of triple negative breast cancer at the 2020 San Antonio Breast Cancer Symposium. |
| 2020-09-18 | Veru Inc. | Results Veru Announces ESMO Congress 2020 Oral Presentation of Positive Clinical Results from its VERU-111 Phase 1b Study in Metastatic Prostate Cancer verupharma.com ↗
today announced that positive clinical results from its Phase 1b study of VERU-111 were orally presented at the European Society for Medical Oncology (ESMO) Congress 2020. |
| 2020-08-04 | Veru Inc. | Results VERU-111 Suppresses Key Cytokines Responsible for Severe Acute Respiratory Distress Syndrome in COVID-19 verupharma.com ↗
VERU-111 significantly reduced key cytokines involved in Acute Respiratory Distress Syndrome in COVID-19 in a toxic shock model |
| 2020-05-12 | Veru Inc. | Regulatory Veru Secures FDA Agreement to Initiate Phase 2 Study of VERU-111, Novel Microtubule Depolymerization Drug to Combat COVID-19 verupharma.com ↗
today announced that it has received FDA permission to initiate a Phase 2 clinical trial to assess the efficacy of VERU-111, a microtubule depolymerization agent, in combating COVID-19, the global pandemic disease caused by the novel coronavirus SARS-CoV-2. |
| 2020-05-05 | Veru Inc. | Results Veru Reports Positive Clinical Results from VERU-111 Phase 1b/2 Trial in Men with Metastatic Castration-Resistant Prostate Cancer, Advancing to Pivotal Phase 3 Clinical Program verupharma.com ↗
VERU-111 Safe and Well Tolerated at Daily Doses 63 mg and Lower; No Significant Neutropenia or Neurotoxicity Observed |
| 2019-12-12 | Veru Inc. | Results Veru Reports Fiscal 2019 Full-Year Net Revenues Doubled, Gross Profit Up 147% verupharma.com ↗
I would like to highlight on the clinical development front, VERU-111 -- our proprietary, oral, next generation, first-in-class, selective antitubulin – as it continues to show antitumor activity and no dose related toxicity in men with metastatic castration resistant prostate cancer. |
| 2018-11-13 | Veru Inc. | Regulatory Veru Advances Novel, First-in-Class Oral Tubulin Inhibitor for Refractory Metastatic Prostate Cancer verupharma.com ↗
Veru Inc. (NASDAQ: VERU), an oncology and urology biopharmaceutical company, today announced that it has submitted an Investigational New Drug (IND) application with the U.S. Food and Drug Administration (FDA) for VERU-111 (bisindole), a first-in-class, next generation, proprietary, oral tubulin inhibitor for the treatment of refractory metastatic prostate cancer. |
| 2018-05-17 | Veru Inc. | Results Veru Announces Publication of Data on Oral VERU-111 in Prostate Cancer in Connection with the 2018 American Society of Clinical Oncology Annual Meeting verupharma.com ↗
Veru Inc. (NASDAQ: VERU), a urology and oncology biopharmaceutical company, today announced the publication of data from preclinical studies of VERU-111, a novel oral alpha and beta tubulin inhibitor, showing potent activity in a highly resistant model of human prostate cancer. |
| 2018-05-17 | Veru Inc. | Results Veru Announces Publication of Data from Three Cancer Studies as Part of the Upcoming American Society of Clinical Oncology Annual Meeting verupharma.com ↗
Veru Inc. (NASDAQ:VERU), a urology and oncology biopharmaceutical company, today announced the publication of data from preclinical studies of VERU-111, a novel oral alpha and beta tubulin inhibitor, that showed efficacy in chemotherapy resistant tumor types. |
| 2018-05-03 | Veru Inc. | Results Veru Announces Presentation of Data Demonstrating Efficacy of VERU-111 in a Taxane Resistant Human Prostate Cancer Model at the 2018 American Urological Association Meeting verupharma.com ↗
IV docetaxel had no impact on tumor growth whereas oral VERU-111 resulted in almost complete inhibition of tumor growth at 10 mg/kg (3 days/ week) as well as 20 mg/kg (1 day/week). |
| 2018-03-16 | Veru Inc. | Results Veru Announces Presentation of Data Demonstrating Efficacy of VERU-111 in a Taxane Resistant Human Prostate Cancer Model at the 2018 Annual EAU Congress verupharma.com ↗
IV docetaxel had no impact on tumor growth whereas oral VERU-111 resulted in almost complete inhibition of tumor growth at 10 mg/kg (3 days/week) as well as 20 mg/kg (1 day/week). |
| 2018-02-06 | Veru Inc. | Results Veru Announces Presentation of Data Demonstrating Efficacy of VERU-111 in a Taxane Resistant Human Prostate Cancer Model at the 2018 Genitourinary Cancers Symposium verupharma.com ↗
IV docetaxel had no impact on tumor growth whereas oral VERU-111 resulted in almost complete inhibition of tumor growth at 10 mg/kg (3 days/ week) as well as 20 mg/kg (1 day/week). |
All press releases naming this drug 54 releases
Evidence & citations 9 cited values
Every value below carries the sentence it was read from. 7 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Sabizabulin | ClinicalTrials.gov intervention name — accepted as the source's own label NCT05008510 ↗ |
| Known as | ABI-231 | ChEMBL registry synonym — accepted as the source's own label CHEMBL2163631 ↗ |
| Known as | APP-111 | ChEMBL registry synonym — accepted as the source's own label CHEMBL2163631 ↗ |
| Known as | SABIZABULIN HYDROCHLORIDE | ChEMBL registry synonym — accepted as the source's own label CHEMBL2163631 ↗ |
| Known as | Sabizatbulin hydrochloride | ChEMBL registry synonym — accepted as the source's own label CHEMBL2163631 ↗ |
| Known as | VERU-111 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT04842747 ↗ |
| Known as | VERU-111 hydrochloride | ChEMBL registry synonym — accepted as the source's own label CHEMBL2163631 ↗ |
| Modality | Small molecule | — CHEMBL2163631 ↗ |
| Route | Oral | “VERU-111 will be administered orally” NCT03752099 ↗ |