Bextra

(Valdecoxib)

ApprovedSmall molecule

Bextra is a small molecule that works as a Cyclooxygenase-2 Inhibitor.[2] It is being used across 9 indications, with its most advanced program in Approved.[1]

Bextra is one of 213 small molecule programs targeting Low back pain. It is currently in Approved.

Indications

Total Trials

Active Trials

212

Competitors

FDA Application

NDA/BLA/ANDA regulatory filings

Pipeline

Status by Indication[3][1]

Indication

Low Back PainActive, not recruiting

Rheumatic DiseaseActive, not recruiting

DysmenorrheaActive, not recruiting

Chronic PainActive, not recruiting

Rheumatoid ArthritisActive, not recruiting

Osteoarthritis, KneeApproved

SprainActive, not recruiting

PharyngitisApproved

Low Back PainApproved

Active, not recruiting

Rheumatic DiseaseApproved

Active, not recruiting

DysmenorrheaApproved

Active, not recruiting

Chronic PainPreclinical

Active, not recruiting

Rheumatoid ArthritisApproved

Active, not recruiting

Osteoarthritis, KneeApproved

Approved

SprainApproved

Active, not recruiting

PharyngitisApproved

Approved

Competition

Competitive Landscape

176 competitors in Rheumatoid Arthritis

#DrugCompanyPhaseTrials

Bextra

TThe Searle Company Limited Pakistan

Approved

1 2

Actos

Takeda

Preclinical

2 3

Celexa

AbbVie

Preclinical

1 4

Voltaren

Plaquenil

Vibramycin

PPfizer's Upjohn has merged with Mylan to form Viatris Inc.

Preclinical

2 7

Velcade

SShilpa Grover, MD, MPH

Preclinical

2 8

Vancocin

HHikma Pharmaceuticals LLC

Preclinical

1 9

Disalcid

JJoslin Diabetes Center

Preclinical

—10

Solu-Medrol

MMassachusetts Eye and Ear Infirmary

Preclinical

—

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Clinical

Trials by Indication[1]

Efficacy and Safety4 trials

Analgesic Efficacy And Safety of Valdecoxib For Treatment Of Post-Surgical Pain From Bunionectomy Surgery

Completed· Pfizer logo

Pfizer·Phase 3·NCT00683137·450 enrolled

A Randomized, Double-Blind Study of the Efficacy and Safety of Valdecoxib Compared to Placebo for Treatment of Post- Cholecystectomy Surgery Pain

Completed· Pfizer logo

Pfizer·Phase 3·NCT00661635·490 enrolled

Double-Blind, Randomized Study Of The Analgesic Efficacy And Safety Of Valdecoxib 20 Mg Daily And Valdecoxib 20 Mg Twice Daily Compared To Placebo For Management Of Acute Postsurgical Pain In Anterior Cruciate Ligament (ACL) Reconstruction

Completed· Pfizer logo

Pfizer·Phase 3·NCT00650039·488 enrolled

Show 1 more trial

A Multicentre, Double-Blind, Double-Dummy, Randomised Study of the Analgesic Efficacy and Safety of Valdecoxib Compared to Diclofenac Sodium in Patients Undergoing Knee Arthroscopy for Anterior Cruciate Ligament (ACL) Reconstruction

Completed· Pfizer logo

Pfizer·Phase 4·NCT00650598·328 enrolled

Osteoarthritis3 trials

A Double-Blind, Double Dummy, Randomized Comparison Study Of The Efficacy And Safety Of Valdecoxib 10mg Once Daily And Naproxen 500mg Twice Daily In Treating The Signs And Symptoms Of Osteoarthritis Of The Knee Or Hip In Taiwan

Completed· Pfizer logo

Pfizer·Phase 3·NCT00648258·130 enrolled

Double-Blind, Double Dummy, Randomized Comparison Study to Evaluate the Efficacy and Safety of Valdecoxib 10 mg Once Daily and Naproxen 500 mg Twice Daily in Treating the Signs and Symptoms of Osteoarthritis of the Knee

Completed· Pfizer logo

Pfizer·Phase 3·NCT00652808·265 enrolled

A Dose-Ranging Study Of Valdecoxib 5 Mg, 10 Mg, And 20 Mg Once Daily Versus Placebo In Patients With Osteoarthritis Of The Knee (Japan)

Completed· Pfizer logo

Pfizer·Phase 2·NCT00650624·416 enrolled

Sprain2 trials

A Double-blind, Double-dummy, Multicenter, Randomized Study of the Efficacy and Tolerability of Valdecoxib 40 mg Versus Rofecoxib 50 mg in Treating the Symptoms of Ankle Sprain

Terminated· Pfizer logo

Pfizer·Phase 4·NCT00657449·45 enrolled

A Multi-Center, Randomized, Double-Blind, Parallel Group Study To Compare The Efficacy And Tolerability Of Valdecoxib And Diclofenac In Patients With A Sprained Ankle

Completed· Pfizer logo

Pfizer·Phase 4·NCT00671320·202 enrolled

Acute Pain1 trial

Genetic Basis For Variation In NSAID Analgesia In A Clinical Model Of Acute Pain

Completed·NNational Institute of Nursing Research (NINR)·Phase 2·NCT00115752·96 enrolled

Pancreatitis1 trial

Efficacy Study of Glyceryl-Trinitrate Patch and Parecoxib (Valdecoxib) for the Prevention of Pancreatitis After Endoscopic Retrograde Cholangiopancreatography (ERCP)

Terminated·—·Phase 2/3·NCT00419549·371 enrolled

8 more indications

Rheumatoid Arthritis1 trial

Efficacy and Safety of Valdecoxib and Naproxen in Treating the Signs and Symptoms of Rheumatoid Arthritis (RA) in a Severe Rheumatoid Arthritis Patients

Completed· Pfizer logo

Pfizer·Phase 4·NCT00650455·489 enrolled

Low back pain1 trial

Randomized, Double Blind, Multicenter Study of the Safety and Efficacy of Valdecoxib 40 mg Once Daily Compared With Diclofenac 75 mg Twice Daily in Acute Low Back Pain

Completed· Pfizer logo

Pfizer·Phase 4·NCT00649610·340 enrolled

Analgesic Efficacy1 trial

Analgesic Efficacy Of Valdecoxib In Patients Following Bunion Surgery

Completed· Pfizer logo

Pfizer·Phase 3·NCT00653354·360 enrolled

Chronic pain1 trial

Valdecoxib in Treating Chronic Pain in Cancer Patients

Completed·—·N/A·NCT00021996

Inflammation1 trial

Perioperative Inflammation and Cyclooxygenase 2 (COX-2)

Completed·UUniversity of Washington·Phase 4·NCT00122096·30 enrolled

Sore Throat1 trial

A Comparison Of Valdecoxib 20 Mg Twice Daily and 40 Mg Daily and Placebo In The Treatment Of Sore Throat

Completed· Pfizer logo

Pfizer·Phase 3·NCT00647829·197 enrolled

Dysmenorrhea1 trial

A Double Blind, Double Dummy, Randomized, Comparative Study Of The Efficacy And Safety Of Valdecoxib 40 Mg Twice Daily, As Needed In The First Menstrual Cycle Day And Then Once A Day, And Piroxicam 40 Mg Once A Day In The Treatment Of Patients With Primary Dysmenorrhea

Completed· Pfizer logo

Pfizer·Phase 4·NCT00649415·154 enrolled

Hyperalgesia1 trial

Effect of Valdecoxib Pretreatment on Pain and Secondary Hyperalgesia in Healthy Volunteers

Completed·PPenn State University·Phase 4·NCT00260325·20 enrolled

Regulatory

FDA Approval Timeline[4]

Nov 16, 2001

BEXTRA

NDA NDA021341

Sources

References

[1]
ClinicalTrials.gov — 19 trial records for Valdecoxib. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Valdecoxib compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Valdecoxib. EMBL-EBI & Wellcome Sanger Institute.
[4]
OpenFDA — FDA approval records (NDA NDA021341). U.S. Food & Drug Administration.
[5]
SEC EDGAR — The Searle Company Limited Pakistan company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: Cyclooxygenase-2 Inhibitor[2]
Modality: Small molecule[2]
Highest Phase: Approved[1]
Company: TThe Searle Company Limited Pakistan

Bextra

Status by Indication[3][1]

Competitive Landscape

Trials by Indication[1]

Efficacy and Safety4 trials

Osteoarthritis3 trials

Sprain2 trials

Acute Pain1 trial

Pancreatitis1 trial

Rheumatoid Arthritis1 trial

Low back pain1 trial

Analgesic Efficacy1 trial

Chronic pain1 trial

Inflammation1 trial

Sore Throat1 trial

Dysmenorrhea1 trial

Hyperalgesia1 trial

FDA Approval Timeline[4]

References

Drug Info

Quick Facts

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