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.

Clinical Trial Conditions for ETODOLAC

Condition Name

Condition Name for ETODOLAC
Intervention	Trials
Fasting	4
Pain, Acute	2
Bursitis	2
Low Back Pain	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, Market Analysis and Projections

Last updated: April 28, 2026

Etodolac is a marketed oral nonsteroidal anti-inflammatory drug (NSAID) used for pain and inflammatory conditions. Commercially, etodolac is a mature, off-patent product in most major jurisdictions, which shifts the competitive landscape toward generic pricing, formulary access, and brand retention in selected channels.

What is the current clinical trial activity for etodolac?

Public registries show limited ongoing late-stage interventional development for etodolac compared with new-chemical-entity NSAIDs. The most visible trial activity tends to fall into these buckets: (1) bioequivalence and formulation studies, (2) comparative pain or inflammation outcomes versus other NSAIDs, and (3) exploratory or label-adjacent studies in specific populations.

Interventional status snapshot (registry-level):

• Most activity is small-sample, short-duration studies focused on efficacy endpoints such as pain scores or functional measures.
• A meaningful share is comparative or pharmacokinetic driven, consistent with an off-patent product cycle where sponsors optimize formulations, dosing regimens, and patient subgroups rather than pursue a full de novo clinical package.

Key implication for development strategy: If a company plans additional clinical work, the highest probability of regulatory and market payoff usually comes from:

• Formulation or dosing optimization (better adherence, fewer GI events, distinct release profiles)
• Defined comparative positioning within specific formularies (payer-driven outcomes, clinician-facing differentiation)
• PK/BE plus pragmatic endpoints that can support product lifecycle claims in markets that still permit incremental labeling

What is the current evidence base landscape?

Etodolac is supported by a long clinical history and established efficacy in standard NSAID indications (pain, osteoarthritis, rheumatoid arthritis, and related inflammatory conditions depending on jurisdiction and labeling). For business planning, the practical value comes less from “new to science” efficacy and more from:

• Safety monitoring patterns that influence prescribing (GI risk, cardiovascular considerations, renal effects typical to NSAIDs)
• Comparative tolerability relative to other NSAIDs in head-to-head or network-analyses
• Patient selection and risk mitigation that impacts real-world adherence and switching rates

In mature NSAID markets, these evidence factors directly influence formulary decisions, rebate pressure, and preferred-brand survival.

How does the market structure look for etodolac?

Competitive set

Etodolac competes primarily against:

• Generic NSAIDs (ibuprofen, naproxen, diclofenac, celecoxib where applicable)
• Other branded NSAID products depending on geography and formulary strategy
• Class-based switching where prescribers move within NSAIDs based on availability and payer tier

Key market drivers

• Generic penetration and price compression: once generics dominate, growth is typically volume-driven (new patients, cycling, or substitution from other NSAIDs).
• Formulary access: preferred status can offset generic erosion by capturing a larger share of prescriptions.
• Real-world safety perception: GI and cardiovascular risk considerations influence conversion between NSAID classes.
• Payer controls: step edits and quantity limits can constrain growth even when clinical differentiation exists.

Where differentiation actually shows up

In off-patent NSAIDs, differentiation usually comes from:

• Formulation and dose convenience (twice daily vs multiple daily regimens; extended-release positioning)
• Localized product claims or tolerability narratives accepted by payers
• Channel strategy (institutional purchasing, specialty pharmacy, insurer preferred tiers)

What do market projections indicate for etodolac?

Etodolac’s projection profile typically follows mature-branded-to-generic transition dynamics:

• Near-term: volume stability or low single-digit growth if the product retains formulary share
• Mid-term: pricing decline continues while overall sales track with prescription demand and competitive substitution
• Downside: accelerated share loss if competing NSAIDs gain preferred tier status through rebate and contracting
• Upside: incremental lifecycle products (new formulation strengths or extended-release positioning) that retain prescription share

Projection framing for investment or planning A realistic base case for a mature NSAID like etodolac is:

• Modest demand growth tied to population and chronic pain prevalence
• Material revenue drag from price erosion
• Strategic value in maintaining distribution and payer preference

What is the most investable pathway for incremental development?

Given the mature status, clinical work that targets regulatory or commercial leverage is usually limited to:

1. Bioequivalence and formulation studies supporting an improved product life cycle
2. Pragmatic comparative studies that confirm meaningful tolerability or convenience in real prescribing conditions
3. Population-specific studies that allow tighter labeling language aligned with payer and clinician decision-making

If a company pursues trials, the economic objective is to support:

• A differentiated product profile (for example extended-release performance or reduced GI burden claims where permissible)
• Faster contracting access via stronger payer-facing claims
• Lower discontinuation risk through usability improvements

What are the main regulatory considerations across markets?

For an established NSAID:

• Regulatory review is typically streamlined for reformulations compared with first-in-class agents.
• Label changes are constrained by existing safety and class-wide risk language.
• Renewed clinical evidence must be tightly tied to a specific claim strategy (PK, BE, or comparative outcomes that matter to clinicians/payers).

So what is the outlook: bullish, neutral, or bearish?

Neutral-to-bearish revenue outlook is the base expectation for most mature NSAIDs because:

• generics drive sustained price pressure,
• competitors can rapidly win formulary tiers,
• and the incremental clinical upside is limited unless the sponsor controls a differentiated lifecycle product.

Neutral-to-bullish share-retention outlook is possible if:

• the sponsor secures preferred status via contracting,
• maintains supply and product availability,
• and introduces lifecycle improvements that preserve a meaningful prescription share.

Key Takeaways

• Etodolac is a mature NSAID with development activity that is usually small, focused, and often formulation or comparative in nature rather than de novo late-stage innovation.
• Market outcomes are dominated by generics, formulary contracting, and payer controls, not by new efficacy breakthroughs.
• Revenue growth is likely constrained by ongoing price erosion; upside depends on share retention and lifecycle differentiation (formulation, dose convenience, and claim strategy).
• Any new trials that matter commercially are the ones that support payer-relevant claims or product differentiation through BE/PK and pragmatic outcomes.

FAQs

1. Is etodolac still being developed in late-stage clinical trials?
   Activity is generally limited and tends to be formulation, PK/BE, or comparative studies rather than broad late-stage programs.

2. What drives etodolac sales in mature markets?
   Generic pricing, formulary tier placement, rebate dynamics, and prescribing behavior within the NSAID class.

3. What type of clinical study is most likely to generate commercial value for an off-patent NSAID?
   Bioequivalence and formulation work, plus pragmatic comparative evidence tied to specific tolerability or usability claims.

4. How does payer strategy typically affect etodolac growth?
   Step edits, quantity limits, and preferred-tier contracting can constrain volume even when clinical demand exists.

5. What is the most realistic upside lever for etodolac?
   Lifecycle differentiation that preserves prescription share, such as extended-release positioning or dosing convenience that improves adherence.

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References (APA)

[1] ClinicalTrials.gov. Etodolac. (n.d.). https://clinicaltrials.gov/
[2] U.S. Food and Drug Administration. Drug trials snapshot: Etodolac (where available). (n.d.). https://www.fda.gov/