➤ Get the DrugPatentWatch Daily Briefing

Get Daily Updates on Generic Entry, Litigation, Biosimilars, and more …

Serving leading biopharmaceutical companies globally:

Baxter
Johnson and Johnson
Colorcon
AstraZeneca
Express Scripts
McKesson

Last Updated: September 21, 2021

DrugPatentWatch Database Preview

CLINICAL TRIALS PROFILE FOR APIXABAN

➤ Get the DrugPatentWatch Daily Briefing

« Back to Dashboard

505(b)(2) Clinical Trials for Apixaban

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials
Trial Type Trial ID Title Status Sponsor Phase Start Date Summary
OTC NCT04550338 ↗ Antiviral Effects of TXA as a Preventative Treatment Following COVID-19 Exposure Not yet recruiting University of Alabama at Birmingham Phase 3 2020-12-01 A recent report in Physiolological Reviews proposed that the endogenous protease plasmin acts on SARS-CoV-2 by cleaving a newly inserted furin site in the S protein portion of the virus resulting in increased infectivity and virulence. A logical treatment that might blunt this process would be the inhibition of the conversion of plasminogen to plasmin. Fortunately, there is an inexpensive, commonly used drug, tranexamic acid, TXA, which suppresses this conversion and could be re-purposed for the treatment of COVID-19. TXA is a synthetic analog of the amino acid lysine which reversibly binds four to five lysine receptor sites on plasminogen. This reduces conversion of plasminogen to plasmin, and is normally used to prevent fibrin degradation. TXA is FDA approved for the outpatient treatment of heavy menstrual bleeding (typical dose 1300 mg p.o. TID x 5 days) and off-label use for many other indications. TXA is used perioperatively as a standard-of-care at UAB for orthopedic and cardiac bypass surgeries. It has a long track record of safety such that it is used over-the-counter in other countries as an antiviral and for the treatment of cosmetic dermatological disorders. Given the potential benefit and limited toxicity of TXA it would appear warranted to perform randomized, double-blind placebo controlled exploratory trial at UAB as a prophylactic antiviral treatment following exposure to COVID-19 in order to determine whether it reduces infectivity and virulence of the SARS-CoV-2 virus as hypothesized. Involvement of each patient is only for 7 days before primary endpoints and 30 days for final data collection.
>Trial Type >Trial ID >Title >Status >Phase >Start Date >Summary

All Clinical Trials for Apixaban

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00097357 ↗ BMS-562247 in Subjects Undergoing Elective Total Knee Replacement Surgery Completed Bristol-Myers Squibb Phase 2/Phase 3 2004-10-01 The purpose of this study is to learn if BMS-562247 can prevent blood clots in the legs and lungs in men and women following unilateral total knee replacement surgery. The safety of this treatment will also be studied.
NCT00252005 ↗ Oral Direct Factor Xa-inhibitor Apixaban in Patients With Acute Symptomatic Deep-vein Thrombosis-The Botticelli DVT Study Completed Bristol-Myers Squibb Phase 2 2005-11-01 The purpose of this clinical research study is to assess efficacy and safety of 3 doses of apixaban 5 mg twice a day, 10 mg twice a day and 20 mg once daily versus conventional treatment with low molecular weight heparin or fondaparinux and vitamin K antagonist in the treatment of subjects with acute symptomatic deep-vein thrombosis.
NCT00313300 ↗ Safety Study of Apixaban in Recent Acute Coronary Syndrome Completed Bristol-Myers Squibb Phase 2 2006-05-01 The purpose of this clinical research study is to determine whether apixaban will be safe in people who have recently had unstable angina or a heart attack.
NCT00320255 ↗ A Phase 2 Pilot Study of Apixaban for the Prevention of Thromboembolic Events in Patients With Advanced (Metastatic) Cancer Completed Ontario Clinical Oncology Group (OCOG) Phase 2 2006-06-01 The purpose of this study is to learn whether apixaban is well-tolerated and acceptable as anticoagulant therapy, when administered to patients with advanced or metastatic cancer and at increased risk for venous thromboembolic events. Demonstration of a favorable benefit:risk profile could lead to significant reduction in this serious and sometimes fatal complication of ongoing cancer and its treatment.
NCT00320255 ↗ A Phase 2 Pilot Study of Apixaban for the Prevention of Thromboembolic Events in Patients With Advanced (Metastatic) Cancer Completed Bristol-Myers Squibb Phase 2 2006-06-01 The purpose of this study is to learn whether apixaban is well-tolerated and acceptable as anticoagulant therapy, when administered to patients with advanced or metastatic cancer and at increased risk for venous thromboembolic events. Demonstration of a favorable benefit:risk profile could lead to significant reduction in this serious and sometimes fatal complication of ongoing cancer and its treatment.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Apixaban

Condition Name

Condition Name for Apixaban
Intervention Trials
Atrial Fibrillation 38
Venous Thromboembolism 27
Pulmonary Embolism 15
Deep Vein Thrombosis 13
[disabled in preview] 0
This preview shows a limited data set
Subscribe for full access, or try a Trial

Condition MeSH

Condition MeSH for Apixaban
Intervention Trials
Atrial Fibrillation 54
Thrombosis 37
Thromboembolism 34
Venous Thromboembolism 29
[disabled in preview] 0
This preview shows a limited data set
Subscribe for full access, or try a Trial

Clinical Trial Locations for Apixaban

Trials by Country

Trials by Country for Apixaban
Location Trials
United States 570
United Kingdom 116
Canada 113
Mexico 93
Japan 80
This preview shows a limited data set
Subscribe for full access, or try a Trial

Trials by US State

Trials by US State for Apixaban
Location Trials
California 28
Texas 26
Pennsylvania 24
Florida 22
North Carolina 21
This preview shows a limited data set
Subscribe for full access, or try a Trial

Clinical Trial Progress for Apixaban

Clinical Trial Phase

Clinical Trial Phase for Apixaban
Clinical Trial Phase Trials
Phase 4 43
Phase 3 48
Phase 2/Phase 3 7
[disabled in preview] 37
This preview shows a limited data set
Subscribe for full access, or try a Trial

Clinical Trial Status

Clinical Trial Status for Apixaban
Clinical Trial Phase Trials
Recruiting 68
Not yet recruiting 62
Completed 36
[disabled in preview] 13
This preview shows a limited data set
Subscribe for full access, or try a Trial

Clinical Trial Sponsors for Apixaban

Sponsor Name

Sponsor Name for Apixaban
Sponsor Trials
Bristol-Myers Squibb 73
Pfizer 30
Assistance Publique - Hôpitaux de Paris 5
[disabled in preview] 10
This preview shows a limited data set
Subscribe for full access, or try a Trial

Sponsor Type

Sponsor Type for Apixaban
Sponsor Trials
Other 198
Industry 124
NIH 5
[disabled in preview] 1
This preview shows a limited data set
Subscribe for full access, or try a Trial

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

Dow
AstraZeneca
McKesson
Express Scripts
Medtronic
Merck

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.