CLINICAL TRIALS PROFILE FOR ETODOLAC

All Clinical Trials for etodolac

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00151736 ↗	Safety and Efficacy of SDX-101 (R-Etodolac) in Combination With Chlorambucil, and That of Chlorambucil Alone, in Patients With Chronic Lymphocytic Leukemia (CLL)	Terminated	Cephalon	Phase 2	2004-09-01	This is a Phase 2, multi-center, open label, randomized clinical study to evaluate the safety and efficiency of SDX-101 in combination with chlorambucil (CLB) and chlorambucil alone in Chronic Lymphocytic Leukaemia (CLL) patients. The study treatment period will be approximately 24-26 weeks with a follow-up period of approximately 8 weeks. Following the end of treatment, patients with a confirmed complete response, partial response or stable disease will be followed for up to 2 years to assess time to disease progression. Approximately 80 patients with documented diagnosis of B-cell CLL by standard clinical and immunophenotyping criteria will be enrolled into the SDX-101-03 study. This study is being conducted in the following European countries: France, Germany, Poland, Sweden and the United Kingdom.
NCT00293111 ↗	Safety and Efficacy of SDX-101 (R-Etodolac) in Patients With Relapsed or Refractory Multiple Myeloma (MM)	Terminated	Cephalon	Phase 2	2002-02-01	An Open Label, Multi-Center, Phase II Study to Investigate the Safety and Efficacy of SDX-101 (R-Etodolac) in Patients with Relapsed or Refractory Multiple Myeloma (MM)
NCT00317447 ↗	The Efficacy of Oral Steroids in the Treatment of Acute Sciatica	Completed	Kaiser Permanente	Phase 3	2002-02-01	Sciatica (lumbosacral radiculopathy) is a common diagnosis in primary care, occurring in approximately one percent of all patients with acute low back pain. (1, 2) Traditional treatment generally involves pain control (acetominophen, NSAID's, or narcotics), activity as tolerated, and time. (1, 3-8 ) The general consensus is that fifty percent of patients with sciatica recover within six weeks, and that ninety percent are better in twelve weeks.(4, 8) Those patients with intractable pain or progressive neurologic symptoms usually receive epidural steroid injections and, if necessary, decompressive laminectomy or discectomy. (2, 8, 9) Low back pain and sciatica result in tremendous losses to our society in terms of decreased productivity and cost of treatment. (1, 12) Oral steroids are inexpensive and relatively safe medications that, if effective in reducing the pain and disability associated with sciatica, could improve the quality of patients' lives, and result in significant cost savings to society at large. We hypothesize that the use of oral steroids to treat acute sciatica will speed patients' recovery as measured by: changes in physical findings, rates of return to work and activities of daily living, pain and disability assessment scores, and decreases in the use of narcotic and non-steroidal anti-inflammatory drugs (NSAID's), and in the need for epidural injection or surgical intervention.
NCT00502684 ↗	Perioperative Administration of COX 2 Inhibitors and Beta Blockers to Women Undergoing Breast Cancer Surgery	Unknown status	Rabin Medical Center	N/A	2014-06-01	Surgery for breast cancer has a major role in enhancing long term survival and cure, but several physiological aspects associated with surgery are implicated as enhancing tumor spread and formation of distant metastases. These include: an increase in pro-angiogenic factors, direct spread of tumor cells, accumulation of grown factors, immune suppression and direct effects of anesthetics and opiate pain relievers on cancer cells. Some of these pro-metastatic mechanism may be blocked by the interventions proposed in this study, namely by administration of beta-adrenergic blockers and COX2 inhibitors around the time of surgery. Studies have shown that surgery increases levels of catecholamines and prostaglandins, which in turn may promote the release of pro-angiogenic factors such as VEGF, and enhance vascularization of micro metastases. Opiates given for pain relief during and after surgery have been reported to enhance tumor cell division and cause immune suppression. The immune system is significantly suppressed during surgery. This suppression has been shown to affect the systemic resistance to infection as well as neoplastic metastatic processes. Several studies have shown that increased levels of catecholamines and prostaglandins add to the immune suppression. Studies in rats found that peri-operative administration of the beta beta-blocker propranolol together with the COX2 inhibitor etodolac significantly reduced the suppression of NK cell activity as well as the risk for distant metastases. A recent retrospective clinical study found that among breast cancer patients treated with a combination of regional anesthesia and a COX inhibitor the recurrence rated were significantly less than among patients undergoing surgery without these two interventions. The purpose of the proposed prospective trial is to examine if peri-operative administration of the combination of a beta-blocker together with a COX2 inhibitor will prevent suppression of cellular immunity, decrease VEGF levels, and decrease cancer recurrence rates. In the proposed study breast cancer patients will be treated with a combination of a beta-blocker and COX2 inhibitor (or placebo) before, during and after surgery. (A control group of healthy women will serve as untreated controls). The variables which will be examined are: number and activity of NK cells, levels of Th1 and Th2 cytokines, serum stress hormones and angiogenic factors, and the ability of leukocytes to produce Th1 and Th2 cytokines as a result of in vitro stimulation. In addition to these immediate parameters, long term follow up will be conducted in order to determine the effect of the intervention on long term cancer recurrence over five years. Statistical analysis will be done using t-tests, ANOVA, and multivariate regressions, with regard to the known risk factors for recurrence such as tumor grade, lymph node involvement etc. Sample size for immunological parameters will be 40 patients in each group and 20 healthy women. Sample size for estimates of cancer recurrence at five years of follow up wiil be 460 women (230 in each group). This sample size provides a power of 80% to detect a 50% reduction in cancer recurrence at an α of 0.05.
NCT00502684 ↗	Perioperative Administration of COX 2 Inhibitors and Beta Blockers to Women Undergoing Breast Cancer Surgery	Unknown status	Sheba Medical Center	N/A	2014-06-01	Surgery for breast cancer has a major role in enhancing long term survival and cure, but several physiological aspects associated with surgery are implicated as enhancing tumor spread and formation of distant metastases. These include: an increase in pro-angiogenic factors, direct spread of tumor cells, accumulation of grown factors, immune suppression and direct effects of anesthetics and opiate pain relievers on cancer cells. Some of these pro-metastatic mechanism may be blocked by the interventions proposed in this study, namely by administration of beta-adrenergic blockers and COX2 inhibitors around the time of surgery. Studies have shown that surgery increases levels of catecholamines and prostaglandins, which in turn may promote the release of pro-angiogenic factors such as VEGF, and enhance vascularization of micro metastases. Opiates given for pain relief during and after surgery have been reported to enhance tumor cell division and cause immune suppression. The immune system is significantly suppressed during surgery. This suppression has been shown to affect the systemic resistance to infection as well as neoplastic metastatic processes. Several studies have shown that increased levels of catecholamines and prostaglandins add to the immune suppression. Studies in rats found that peri-operative administration of the beta beta-blocker propranolol together with the COX2 inhibitor etodolac significantly reduced the suppression of NK cell activity as well as the risk for distant metastases. A recent retrospective clinical study found that among breast cancer patients treated with a combination of regional anesthesia and a COX inhibitor the recurrence rated were significantly less than among patients undergoing surgery without these two interventions. The purpose of the proposed prospective trial is to examine if peri-operative administration of the combination of a beta-blocker together with a COX2 inhibitor will prevent suppression of cellular immunity, decrease VEGF levels, and decrease cancer recurrence rates. In the proposed study breast cancer patients will be treated with a combination of a beta-blocker and COX2 inhibitor (or placebo) before, during and after surgery. (A control group of healthy women will serve as untreated controls). The variables which will be examined are: number and activity of NK cells, levels of Th1 and Th2 cytokines, serum stress hormones and angiogenic factors, and the ability of leukocytes to produce Th1 and Th2 cytokines as a result of in vitro stimulation. In addition to these immediate parameters, long term follow up will be conducted in order to determine the effect of the intervention on long term cancer recurrence over five years. Statistical analysis will be done using t-tests, ANOVA, and multivariate regressions, with regard to the known risk factors for recurrence such as tumor grade, lymph node involvement etc. Sample size for immunological parameters will be 40 patients in each group and 20 healthy women. Sample size for estimates of cancer recurrence at five years of follow up wiil be 460 women (230 in each group). This sample size provides a power of 80% to detect a 50% reduction in cancer recurrence at an α of 0.05.
NCT00502684 ↗	Perioperative Administration of COX 2 Inhibitors and Beta Blockers to Women Undergoing Breast Cancer Surgery	Unknown status	Tel Aviv University	N/A	2014-06-01	Surgery for breast cancer has a major role in enhancing long term survival and cure, but several physiological aspects associated with surgery are implicated as enhancing tumor spread and formation of distant metastases. These include: an increase in pro-angiogenic factors, direct spread of tumor cells, accumulation of grown factors, immune suppression and direct effects of anesthetics and opiate pain relievers on cancer cells. Some of these pro-metastatic mechanism may be blocked by the interventions proposed in this study, namely by administration of beta-adrenergic blockers and COX2 inhibitors around the time of surgery. Studies have shown that surgery increases levels of catecholamines and prostaglandins, which in turn may promote the release of pro-angiogenic factors such as VEGF, and enhance vascularization of micro metastases. Opiates given for pain relief during and after surgery have been reported to enhance tumor cell division and cause immune suppression. The immune system is significantly suppressed during surgery. This suppression has been shown to affect the systemic resistance to infection as well as neoplastic metastatic processes. Several studies have shown that increased levels of catecholamines and prostaglandins add to the immune suppression. Studies in rats found that peri-operative administration of the beta beta-blocker propranolol together with the COX2 inhibitor etodolac significantly reduced the suppression of NK cell activity as well as the risk for distant metastases. A recent retrospective clinical study found that among breast cancer patients treated with a combination of regional anesthesia and a COX inhibitor the recurrence rated were significantly less than among patients undergoing surgery without these two interventions. The purpose of the proposed prospective trial is to examine if peri-operative administration of the combination of a beta-blocker together with a COX2 inhibitor will prevent suppression of cellular immunity, decrease VEGF levels, and decrease cancer recurrence rates. In the proposed study breast cancer patients will be treated with a combination of a beta-blocker and COX2 inhibitor (or placebo) before, during and after surgery. (A control group of healthy women will serve as untreated controls). The variables which will be examined are: number and activity of NK cells, levels of Th1 and Th2 cytokines, serum stress hormones and angiogenic factors, and the ability of leukocytes to produce Th1 and Th2 cytokines as a result of in vitro stimulation. In addition to these immediate parameters, long term follow up will be conducted in order to determine the effect of the intervention on long term cancer recurrence over five years. Statistical analysis will be done using t-tests, ANOVA, and multivariate regressions, with regard to the known risk factors for recurrence such as tumor grade, lymph node involvement etc. Sample size for immunological parameters will be 40 patients in each group and 20 healthy women. Sample size for estimates of cancer recurrence at five years of follow up wiil be 460 women (230 in each group). This sample size provides a power of 80% to detect a 50% reduction in cancer recurrence at an α of 0.05.
NCT00502684 ↗	Perioperative Administration of COX 2 Inhibitors and Beta Blockers to Women Undergoing Breast Cancer Surgery	Unknown status	Tel-Aviv Sourasky Medical Center	N/A	2014-06-01	Surgery for breast cancer has a major role in enhancing long term survival and cure, but several physiological aspects associated with surgery are implicated as enhancing tumor spread and formation of distant metastases. These include: an increase in pro-angiogenic factors, direct spread of tumor cells, accumulation of grown factors, immune suppression and direct effects of anesthetics and opiate pain relievers on cancer cells. Some of these pro-metastatic mechanism may be blocked by the interventions proposed in this study, namely by administration of beta-adrenergic blockers and COX2 inhibitors around the time of surgery. Studies have shown that surgery increases levels of catecholamines and prostaglandins, which in turn may promote the release of pro-angiogenic factors such as VEGF, and enhance vascularization of micro metastases. Opiates given for pain relief during and after surgery have been reported to enhance tumor cell division and cause immune suppression. The immune system is significantly suppressed during surgery. This suppression has been shown to affect the systemic resistance to infection as well as neoplastic metastatic processes. Several studies have shown that increased levels of catecholamines and prostaglandins add to the immune suppression. Studies in rats found that peri-operative administration of the beta beta-blocker propranolol together with the COX2 inhibitor etodolac significantly reduced the suppression of NK cell activity as well as the risk for distant metastases. A recent retrospective clinical study found that among breast cancer patients treated with a combination of regional anesthesia and a COX inhibitor the recurrence rated were significantly less than among patients undergoing surgery without these two interventions. The purpose of the proposed prospective trial is to examine if peri-operative administration of the combination of a beta-blocker together with a COX2 inhibitor will prevent suppression of cellular immunity, decrease VEGF levels, and decrease cancer recurrence rates. In the proposed study breast cancer patients will be treated with a combination of a beta-blocker and COX2 inhibitor (or placebo) before, during and after surgery. (A control group of healthy women will serve as untreated controls). The variables which will be examined are: number and activity of NK cells, levels of Th1 and Th2 cytokines, serum stress hormones and angiogenic factors, and the ability of leukocytes to produce Th1 and Th2 cytokines as a result of in vitro stimulation. In addition to these immediate parameters, long term follow up will be conducted in order to determine the effect of the intervention on long term cancer recurrence over five years. Statistical analysis will be done using t-tests, ANOVA, and multivariate regressions, with regard to the known risk factors for recurrence such as tumor grade, lymph node involvement etc. Sample size for immunological parameters will be 40 patients in each group and 20 healthy women. Sample size for estimates of cancer recurrence at five years of follow up wiil be 460 women (230 in each group). This sample size provides a power of 80% to detect a 50% reduction in cancer recurrence at an α of 0.05.

Clinical Trial Conditions for etodolac

Condition Name

Condition Name for etodolac
Intervention	Trials
Fasting	4
Bursitis	2
Low Back Pain	2
Colorectal Neoplasms	2

Condition MeSH

Condition MeSH for etodolac
Intervention	Trials
Acute Pain	3
Malnutrition	3
Low Back Pain	2
Back Pain	2

Clinical Trial Locations for etodolac

Trials by Country

Trials by Country for etodolac
Location	Trials
United States	85
India	7
Israel	5
Turkey	2
Brazil	2

Trials by US State

Trials by US State for etodolac
Location	Trials
California	8
Texas	8
Florida	6
Ohio	5
New York	5

Clinical Trial Progress for etodolac

Clinical Trial Phase

Clinical Trial Phase for etodolac
Clinical Trial Phase	Trials
PHASE2	1
Phase 4	3
Phase 3	9

Clinical Trial Status

Clinical Trial Status for etodolac
Clinical Trial Phase	Trials
Completed	19
Recruiting	5
Terminated	3

Clinical Trial Sponsors for etodolac

Sponsor Name

Sponsor Name for etodolac
Sponsor	Trials
IPCA Laboratories Ltd.	6
MEDRx USA, Inc.	5
Sheba Medical Center	4

Sponsor Type

Sponsor Type for etodolac
Sponsor	Trials
Other	30
Industry	18
NIH	1

Etodolac clinical trials update and market projection (2026): pipeline status, competitive dynamics, and revenue outlook

Last updated: July 28, 2026

Etodolac, an NSAID indicated for pain and inflammation, is an established, off-patent small molecule in most markets. Current “clinical trials updates” for etodolac largely skew to formulation, comparative efficacy, pharmacokinetic (PK), and post-approval studies rather than late-stage registration trials for new indications. Market growth is more tied to utilization, formulary placement, and generic competition than to new product launches.

This update consolidates the clinically relevant trial types and the market factors that drive near- and mid-term revenue, with projections centered on generic erosion and switching dynamics.

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What clinical trials are ongoing for etodolac in 2024-2026?

Answer: Ongoing etodolac activity in this window typically consists of (1) bioequivalence and PK studies, (2) comparative pain or inflammation trials against other NSAIDs or active controls, and (3) formulation/route adaptations (for example, extended-release or topical concepts). Late-stage phase 3 “new indication” programs are generally not the dominant pattern for etodolac given its long market history.

Trial categories that remain most common for established NSAIDs like etodolac

Bioequivalence and PK

• Demonstrate equivalence of generics to listed reference products.
• Often conducted as single-dose or steady-state crossovers.
• Primary endpoints: Cmax, Tmax, AUC, and safety.

Comparative analgesia or anti-inflammatory efficacy

• Head-to-head or active-control designs versus other NSAIDs (ibuprofen, naproxen, diclofenac, celecoxib) or non-NSAID comparators depending on protocol.
• Outcomes often measured as pain scores, functional scores, and time-to-require rescue medication.

Real-world effectiveness and safety

• Observational or pragmatic studies tracking GI, renal, cardiovascular risk signals.
• Often aligned with risk-minimization approaches in NSAID labeling.

Formulation and regimen optimization

• IR vs ER comparisons or dissolution/performance changes.
• Combination studies with gastroprotective or adjunctive agents are less common for etodolac specifically but appear across the NSAID class.

What to watch in trial updates

• Recruitment status and completion dates for PK/BE trials, since they can shift launch timing for new generic strengths or dosage forms.
• Safety endpoints tracking NSAID class signals (GI events) that may affect labeling supplements and marketing risk.

(No specific trial registry identifiers, dates, or endpoints are provided here because the prompt does not include a target jurisdiction or reference dataset, and the required database-level details are not included in the input.)

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How is etodolac performing in the market now: brand vs generic share?

Answer: Etodolac is predominantly generic. The practical market structure is reference-listing-based originator residual share plus multiple generic manufacturers capturing the majority of prescriptions across typical NSAID pain indications.

Market drivers that typically determine etodolac utilization

• Formulary tiering (preferred NSAIDs list placement).
• Step therapy rules that steer patients toward lower WAC products.
• Net price compression from multiple ANDA entrants.
• Prescriber preference for efficacy, tolerability, and dosing convenience.
• Local adverse event patterns (GI intolerance) influencing switching to alternative NSAIDs.

Market headwinds

• NSAID class substitution risk: multiple therapeutic equivalents compete on broad pain indications.
• Continued generic price pressure in the US and parallel erosion in other markets where patents have expired.

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What is the etodolac revenue outlook through 2028?

Answer: Revenue is projected to remain flat-to-declining in nominal terms in the absence of patent-protected new formulations or new regulatory exclusivities. Growth, if any, is expected from unit volume (switches within NSAID class, incremental population treatment, substitution where etodolac is favored) offset against price erosion from ongoing generic competition.

Projection logic used for established, off-patent NSAIDs

1. Units: stable or modest growth based on baseline pain prevalence and prescribing cycles.
2. Price: negative trend due to generics and periodic entrants.
3. Mix: ER or specific strengths can temporarily stabilize value through patient preference, but sustained premium is limited by therapeutically equivalent alternatives.

Revenue projection framework (directional)

• 2026-2027: modest unit stability; net value declines driven by pricing.
• 2028: continued competitive pressure likely keeps the trajectory flat-to-down unless a major reformulation gains durable uptake.

(No numerical forecasts are provided because the prompt does not supply historical sales, geography, or channel mix required for quantitative modeling.)

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Which companies compete with etodolac generics?

Answer: The etodolac space is competitive across typical generic manufacturers with ANDA portfolios for NSAIDs. Competition is less about differentiation and more about (1) supply reliability, (2) acquisition of reference-listing leverage for specific strengths/dosage forms, and (3) pricing strategies driven by margin targets.

Competitive dimensions that matter commercially

• Strength coverage (for example, common oral strengths that map to prescriber habits).
• Dosage form consistency (IR versus ER, pill size, dissolution).
• Label compliance for chronic use indications.
• Manufacturing scale and quality records that reduce the risk of supply interruptions.

(No specific company list is provided because the prompt does not include the target market (US only vs ex-US), nor does it provide the Orange Book reference set needed to enumerate ANDA filers by strength.)

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What patent estate protects etodolac in the US, and when does exclusivity end?

Answer: Etodolac is generally off patent in the US for core chemical entity and many early formulation claims. For an established NSAID, remaining protections typically fall into one of these buckets:

• legacy patents that have longer term dependents in specific dosage forms or processes (often expired or near expiry), or
• newer patents on specific formulations, solid-state forms, or manufacturing methods (often not broad enough to block generic entry on the base product).

How to evaluate remaining US exclusivity for etodolac

• Orange Book listing status: drug product and active ingredient listings by strength and dosage form.
• Patent type: composition, method of use, or formulation/process.
• Enforcement posture: whether any listed patents have active litigation or a continuing dispute.
• If no active listed patents block approval, the practical entry timeline becomes controlled by regulatory and manufacturing readiness rather than exclusivity.

(No Orange Book table is included because the prompt does not provide a reference Orange Book dataset snapshot or the specific dosage forms/strengths to query and map to listed patents.)

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Are there Paragraph IV challenges for etodolac?

Answer: For mature NSAIDs, Paragraph IV activity can occur when generic applicants challenge listed patents tied to specific strengths/dosage forms. Whether Paragraph IV occurred recently for etodolac depends on (1) whether any Orange Book patents remained unexpired at the time of the ANDA submission, and (2) the applicant’s decision to litigate rather than design around or wait.

Practical impact of Paragraph IV on market entry

• Settlement agreements can create “launch windows” even for drugs that are otherwise off patent.
• Litigation outcomes determine whether challengers can market on an agreed date or after an adverse ruling.

(No specific case list is included because the input does not include a target set of Orange Book-listed patents or FDA/ANDA docket references.)

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What is the FDA regulatory status of etodolac: ANDA, labeling, and safety updates?

Answer: Etodolac is approved as a marketed NSAID with established FDA labeling for pain and inflammation indications. Current regulatory relevance usually centers on:

• updated labeling reflecting safety communications across the NSAID class (GI risk, renal risk, cardiovascular risk),
• ongoing ANDA approvals for generic strengths/dosage forms,
• potential REMS-like risk management is generally not typical for NSAIDs, but labeling changes are frequent.

Regulatory “watch items”

• Label revisions tied to safety communications (FDA NSAID class updates).
• Manufacturing site approvals and inspections affecting supply continuity.
• Any pediatric labeling updates, if applicable to the marketed formulations.

(No FDA approval timeline or label version breakdown is included because the prompt does not specify the NDA/BLA reference drug number(s) or the label version to analyze.)

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How does etodolac compare with other NSAIDs on efficacy and safety?

Answer: Clinically, etodolac competes within the NSAID class on comparable analgesic and anti-inflammatory effects. Differentiation is often secondary to:

• dosing convenience,
• tolerability in individual patients (especially GI tolerability),
• payer preference and step therapy. Safety profiles remain NSAID-class consistent, with risks driven by patient factors and duration of therapy.

Competitive comparison targets for market access

• Celecoxib (COX-2 selective) for GI risk trade-offs.
• Naproxen and ibuprofen for coverage and cost.
• Diclofenac and others depending on topical vs oral strategy.

(This section is qualitative since the prompt does not request head-to-head trial citations or provide a comparator set.)

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What generic entry risks exist for etodolac?

Answer: Generic entry is generally feasible given off-patent status in most jurisdictions; principal risks tend to be regulatory and operational rather than IP-blocking:

• Orange Book listing barriers tied to any remaining formulation or method patents (if present),
• bioequivalence study variability risks for certain formulations,
• manufacturing quality risks that delay launches.

Key operational risks

• BE study failures requiring reformulation or additional bridging work.
• Supply chain constraints affecting timely launch and contract fulfillment.

(No specific IP-entry barriers are enumerated because the prompt does not provide patent listing data to identify which claims, if any, still matter for specific dosage forms.)

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Key Takeaways

• Etodolac is a mature NSAID with an operating environment dominated by generics, formulary dynamics, and NSAID class safety positioning.
• Recent clinical trial activity in this therapeutic class typically centers on PK/BE, comparative studies, and formulation optimization rather than new large-scale registration programs.
• Near-term revenue outlook is flat-to-down in value, driven by ongoing price compression, with units potentially stabilizing depending on formulary access and dosing convenience.
• IP leverage is generally limited for core etodolac; any remaining patent impact is likely tied to specific dosage forms or legacy dependent claims.
• Market entry risk for generics is more operational and regulatory than IP blocking, unless specific Orange Book patents remain active for particular strengths/dosage forms.

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FAQs

1. What dosage forms of etodolac attract the most generic competition?
2. Do etodolac formulation changes (IR vs ER) affect generic bioequivalence requirements?
3. How do payer step-therapy policies typically impact etodolac prescribing versus preferred NSAIDs?
4. Are there safety-label updates for etodolac that materially change patient usage patterns?
5. What market signals indicate a new generic launch wave for etodolac strengths in the US?

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References

(No sources were cited because the prompt did not provide a target dataset (FDA Orange Book, ClinicalTrials.gov, or sales figures) and no in-text factual claims were tied to specific verifiable documents.)