CLINICAL TRIALS PROFILE FOR VALDECOXIB

All Clinical Trials for valdecoxib

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00021996 ↗	Valdecoxib in Treating Chronic Pain in Cancer Patients	Completed	Dana-Farber Cancer Institute	N/A	2001-01-01	RATIONALE: Valdecoxib may be effective in relieving chronic pain in cancer patients. It is not yet known if valdecoxib is effective in treating chronic pain. PURPOSE: Randomized clinical trial to study the effectiveness of valdecoxib in relieving chronic pain in cancer patients.
NCT00092300 ↗	A Study of Two Approved Drugs in the Treatment of Postoperative Dental Pain (0966-181)(COMPLETED)	Completed	Merck Sharp & Dohme Corp.	Phase 3	2002-05-01	The purpose of this study is to compare the safety and effectiveness of two approved drugs in the treatment of pain following dental surgery.
NCT00092339 ↗	A Study of Two Approved Drugs in the Treatment of Postoperative Dental Pain (0966-190)(COMPLETED)	Completed	Merck Sharp & Dohme Corp.	Phase 3	2002-08-01	The purpose of this study is to compare the safety and effectiveness of two approved drugs in the treatment of pain following dental surgery.
NCT00115752 ↗	Genetic Basis For Variation In NSAID Analgesia In A Clinical Model Of Acute Pain	Completed	National Institute of Nursing Research (NINR)	Phase 2	2005-06-20	This study will evaluate how genetic makeup contributes to the variation in people regarding their sensitivity to and experience of pain. Scientists believe that differences in information found in genes may explain why an analgesic drug, that is, one that treats pain, works effectively for some people but not for others. The study will explore pain that is acute (fast and short period). Knowledge gained from this ongoing study may permit development of an individualized analgesic drug prescription. Patients ages 16 to 35 who are in good health and have been referred for removal of impacted wisdom teeth; who are not allergic to aspirin or other nonsteroidal anti-inflammatory drugs (known as NSAIDs), sulfites, or certain anesthetics; who are not pregnant or nursing; and who are willing to have a biopsy before and after dental surgery are eligible for this study. Patients will come to the clinic for one test visit and one treatment visit. During the first visit, a questionnaire will evaluate patients' psychological state, including mood and depression. There will be a clinical examination of their wisdom teeth. A blood sample of 10 milliliters (about 0.4 ounces) will be collected from the forearm to provide DNA material containing genes stored in cells. The primary genetic analysis will be done at NIH, although the DNA collected might also be sent to a laboratory outside NIH. DNA samples will be coded so that names of patients cannot be traced. During the second visit, two of the patients' lower wisdom teeth will be removed. Patients will be given a local anesthetic in the mouth and a sedative given through a vein in the arm. While the mouth is numb, a small piece of tissue will be removed from inside the cheek, near the wisdom tooth. It is the first biopsy. After the two wisdom teeth are removed, a small piece of tubing will be placed into both sides of the mouth where the teeth were removed. Every 20 minutes, for the next 3 hours, the researchers will collect inflammatory fluid from the tubing, to measure the chemicals thought to cause pain and swelling. Also every 20 minutes, patients will rate the pain they feel by answering questions. If there is pain before 3 hours following surgery, they will receive a dose of fentanyl to relieve moderate to severe pain. A second biopsy will occur 3 hours after surgery, to measure changes in chemicals produced in response to surgery. Immediately afterward, patients will receive 30 mg of ketorolac (Toradol) whether or not pain is felt. They will answer questionnaires about pain for 3 hours after receiving the drug, to rate how well it works. They will stay at the clinic up to 6 hours after the surgery. If pain is not relieved with ketorolac, patients will receive a one-time dose of tramadol, a pain medication for moderate to severe pain. After the study procedures are completed, patients will receive pain medication for pain after surgery. Patients will be monitored closely, because all drugs have side effects. Ketorolac is a nonsteroidal anti-inflammatory drug, one that may cause gastrointestinal upset. Fentanyl is a powerful narcotic drug that is safe at the dosage used in this study, but stomach upset, dizziness, and breathing trouble may occur. Also, risks from the biopsy include discomfort from injecting the numbing medicine, infection, and bleeding. There may be discomfort from the sedative injected into the vein, and there may be bruising. Benefits from participating are having wisdom teeth removed at no cost as well as close monitoring before and after surgery. There are no plans to give patients the results of genetic tests or questionnaires. Years of research may be needed before such information has the chance to become meaningful.

Clinical Trial Conditions for valdecoxib

Condition Name

Condition Name for valdecoxib
Intervention	Trials
Pain	10
Osteoarthritis	2
Postoperative Pain	2
Sprains and Strains	2

Condition MeSH

Condition MeSH for valdecoxib
Intervention	Trials
Pain, Postoperative	7
Signs and Symptoms	3
Osteoarthritis, Knee	3
Osteoarthritis	3

Clinical Trial Locations for valdecoxib

Trials by Country

Trials by Country for valdecoxib
Location	Trials
United States	114
Brazil	22
Canada	12
Colombia	11
Japan	9

Trials by US State

Trials by US State for valdecoxib
Location	Trials
Pennsylvania	7
California	6
Arizona	6
Maryland	6
Texas	6

Clinical Trial Progress for valdecoxib

Clinical Trial Phase

Clinical Trial Phase for valdecoxib
Clinical Trial Phase	Trials
Phase 4	13
Phase 3	11
Phase 2/Phase 3	1

Clinical Trial Status

Clinical Trial Status for valdecoxib
Clinical Trial Phase	Trials
Completed	24
Terminated	4
Active, not recruiting	1

Clinical Trial Sponsors for valdecoxib

Sponsor Name

Sponsor Name for valdecoxib
Sponsor	Trials
Pfizer	20
Merck Sharp & Dohme Corp.	3
Fundação de Amparo à Pesquisa do Estado de São Paulo	2

Sponsor Type

Sponsor Type for valdecoxib
Sponsor	Trials
Industry	23
Other	12
NIH	3

Valdecoxib Market Analysis and Financial Projection

Last updated: February 13, 2026

Clinical Trials Update

Valdecoxib, marketed as Bextra, was withdrawn from the U.S. market in 2005 following safety concerns related to cardiovascular risks[1]. Current clinical trials involving valdecoxib are virtually nonexistent, reflecting the drug’s market discontinuation and regulatory withdrawal. No active Phase I-III trials are documented in major databases such as ClinicalTrials.gov since 2005.

However, interest persists in derivatives or similar COX-2 inhibitors with improved safety profiles. Investigational studies focus on modified formulations or additional indications. Existing research, primarily in preclinical stages, explores potential applications in conditions like osteoarthritis and rheumatoid arthritis, but these remain experimental efforts rather than progressing toward new approvals.

Market Analysis

Historical Market Context

Valdecoxib was once part of the NSAID and selective COX-2 inhibitor markets. Prior to withdrawal, Bextra had annual sales exceeding $700 million at its peak, representing approximately 4% of the NSAID segment[2].

Market Size and Segmentation

Activity in the NSAID space is dominated by drugs like celecoxib (Celebrex) and diclofenac. The global NSAID market size was valued at around $12 billion in 2021, with COX-2 inhibitors accounting for roughly 35% of the segment[3].

Competitive Landscape

In the wake of valdecoxib’s withdrawal, celecoxib remains the leading COX-2 inhibitor. Other alternatives include non-selective NSAIDs and emerging biologicals for inflammatory diseases. The market has shifted toward drugs with better safety profiles and longer approval histories.

Current Regulatory Stance

Regulatory agencies, including the FDA, withdrew Bextra citing increased cardiovascular risk[1]. This caution influences development directions, making approval of similar agents a high bar without significant safety modifications.

Future Outlook and Projections

Market Penetration

Given the regulatory history and safety concerns, the likelihood of reintroducing valdecoxib as is seems low. Development efforts, if any, are directed toward analogs or compounds with a similar mechanism but lower cardiovascular risk.

R&D Investment

Biotech firms and pharmaceutical companies have scaled back investment in new COX-2 inhibitors, favoring drugs with proven safety profiles. Small ventures explore targeted delivery systems or combination therapies, but these are in early stages.

Market Forecast (2023–2030)

The NSAID market is projected to grow at 4% annually, reaching approximately $16.5 billion by 2030[3]. COX-2 inhibitor share will likely remain stable or decline, given safety concerns. No significant market growth is expected for valdecoxib itself; focus shifts toward safer, innovative anti-inflammatory therapies.

Regulatory Trends

Regulators continue emphasizing cardiovascular safety in NSAID and COX-2 inhibitor approvals, discouraging the reintroduction of drugs with prior safety issues[1]. This regulatory environment serves as a barrier for any re-entry of valdecoxib or its analogs.

Key Takeaways

• Valdecoxib was withdrawn in 2005 due to cardiovascular risks; no ongoing clinical trials suggest active development.
• The NSAID market is $12 billion, with COX-2 inhibitors holding approximately 35%, but valdecoxib’s market is effectively closed.
• Future drugs in this class face stringent safety hurdles; efforts target safer modifications or novel anti-inflammatory mechanisms.
• Market growth prospects for valdecoxib are minimal; focus centers on innovative therapies with improved safety profiles.

FAQs

1. Is valdecoxib available for any new clinical trials? No. The drug was withdrawn from the market in 2005, and no active trials are registered.

2. Could valdecoxib be reintroduced someday? Reintroduction is unlikely unless significant safety enhancements are demonstrated, given past safety concerns.

3. What alternatives are used for conditions valdecoxib targeted? Celecoxib remains the primary COX-2 inhibitor, alongside non-selective NSAIDs.

4. Are there new COX-2 inhibitors under development? Few are in late-stage development; most efforts focus on drugs with improved safety profiles or alternative mechanisms.

5. How does the safety issue impact the NSAID market? Regulatory caution emphasizes safety, limiting re-entry prospects for older drugs like valdecoxib and shaping future R&D priorities.

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Citations

[1] U.S. Food and Drug Administration. "Bextra (valdecoxib) label," 2005.

[2] IMS Health. "NSAID Market Analysis," 2015.

[3] MarketsandMarkets. "NSAID Market by Application," 2022.