Last update 21 Nov 2024

Etodolac

Last update 21 Nov 2024

Overview

R&D Status

Clinical Result

Translational Medicine

Overview

Basic Info

Drug Type

Small molecule drug

Synonyms

(1,8-Diethyl-1,3,4,9-tetrahydro-pyrano[3,4-b]indol-1-yl)-acetic acid, (±)-1,8-diethyl-1,3,4,9-tetrahydropyrano(3,4-b)indole-1-acetic acid, 1,3,4,9-tetrahydro-1,8-diethylpyrano(3,4-b)indole-1-acetic acid

+ [20]

Target

COX-2

Mechanism

COX-2 inhibitors(Cyclooxygenase-2 inhibitors)

Therapeutic Areas

Nervous System DiseasesOther DiseasesNeoplasms+ [4]

Active Indication

AnalgesiaInflammationPain+ [2]

Inactive Indication

Osteoarthritis

Originator Organization

Pfizer Inc.

Active Organization

Nippon Shinyaku Co., Ltd.

ASKA Pharmaceutical Co., Ltd.

Hamamatsu University School of Medicine

Inactive Organization

Wyeth Pharmaceuticals LLC

Drug Highest PhaseApproved

First Approval Date

US (31 Jan 1991),

OsteoarthritisPain

Regulation-

Structure

Molecular FormulaC17H21NO3

InChIKeyNNYBQONXHNTVIJ-UHFFFAOYSA-N

CAS Registry41340-25-4

Clinical Trials associated with Etodolac

NCT05429970 / RecruitingNot ApplicableIIT

Perioperative Stress Reduction in Ovarian Cancer (PRESERVE Trial)-A Prospective Randomized Pilot Study

The purpose of this study is to see if propranolol and etodolac along with mind-body resilience training/MBRT and music therapy help participants who are experiencing physiological stress before, during, and after primary debulking surgery/PDS or IDS and also if it's better than the standard-of-care approach (no intervention for reducing stress).

Start Date17 Jun 2022

Sponsor / Collaborator

Memorial Sloan Kettering Cancer Center

ChiCTR2100046838 / RecruitingEarly Phase 1IIT

Lodine bioavailability from different sources of dietary iodine intake in human trail derived from dietary iodine reference intake research for young adults

Start Date12 May 2021

Sponsor / Collaborator-

NCT03838029 / RecruitingPhase 2IIT

Perioperative Use of a Beta-adrenergic Blocker and a COX-2 Inhibitor in Patients Undergoing Surgery With Primary Pancreatic Cancer: Intervention Aiming to Reduce Pro-metastatic Processes

In Israel, of the
1000 patients diagnosed annually with pancreatic cancer (PC), approximately 250 (25 percent) will be eligible for curative surgery, of which 80 percent will succumb to post-surgical metastatic disease. A reduction in post-surgical metastatic disease will save dozens of patients in Israel annually, and tens-of thousands-around the world. The short perioperative period (days to weeks around surgery) is characterized by stress-inflammatory responses, including catecholamines (CAs, e.g., adrenaline) and prostaglandins (PGs, e.g., prostaglandin-E2) release, and induce deleterious pro-metastatic effects. Animal studies implicated excess perioperative release of CAs and PGs in facilitating cancer progression by affecting the malignant tissue, its local environment, and anti-metastatic immune functions. Congruently, our animal studies indicate that combined use of the beta-adrenergic blocker, propranolol, and the prostaglandins inhibitor, etodolac - but neither drug separately - efficiently prevented post-operative metastatic development. We recently conducted two clinical trials in three medical centers in Israel, recruiting breast (n=38) and colorectal (n=34) cancer patients, assessing the safety and short-term efficacy of perioperative propranolol and etodolac treatment. Drugs were well tolerated, without severe adverse events. Importantly, molecular/biological analyses of the excised primary tumor indicated that drug treatment caused promising anti-metastatic transformations, as well as improvements in immune and inflammatory indices. These included (i) decreased tumor cell capacity to migrate, (ii) reduced pro-metastatic capacity of the malignant tissue, and (iii) improvement in immune infiltrating into the tumor (Paper published in Clinical Cancer Research, 2017). Herein, we propose to conduct a double-blind placebo-controlled two-arm Phase II clinical trial in 210 pancreatic cancer patients undergoing curative surgery in Israel. A perioperative 35-day drug treatment will be initiated 5 days before surgery. Primary outcomes will include (i) 1-year disease-free-survival (DFS), and 5-year overall survival (OS); and (ii) biological markers in blood samples, and in the excised tumor tissue. Secondary outcomes will include safety indices and psychological measures of depression, anxiety, distress, and fatigue.

Start Date20 Nov 2019

Sponsor / Collaborator

Assaf Harofeh Medical Center

[+1]

100 Clinical Results associated with Etodolac

100 Translational Medicine associated with Etodolac

100 Patents (Medical) associated with Etodolac

790

Literatures (Medical) associated with Etodolac

18 Sep 2024·RSC advances

Synthetic pathways to create asymmetric center at C1 position of 1-substituted-tetrahydro-β-carbolines - a review.

Review

Author: Lisa, Susmita Roy ; Asif, Md Moaz Ahmed ; Qais, Nazmul

The 2,3,4,9-tetrahydro-1H-pyrido[3,4-b]indoles or tetrahydro-β-carbolines (THβCs) are tricyclic compounds that are found in various natural sources that exhibit a wide range of important pharmacological activities. Chiral 1-substituted-THβCs, which have an asymmetric center at C1, have attained significant interest due to their possible Monoamine Oxidase (MAO) inhibitory activity, benzodiazepine receptor binding activity, and antimalarial effectiveness against chloroquine-resistant Plasmodium falciparum. This review highlights and summarizes various novel stereoselective approaches to introduce chirality at the C1 position of 1-substituted-THβCs in good yield and enantiomeric excess (ee) or diastereomeric excess (de). These methods include the Pictet-Spengler reaction, chiral auxiliary, Asymmetric Transfer Hydrogenation (ATH) with chiral catalysts, asymmetric addition reaction, and enzymatic catalysis. The syntheses of chiral THβCs are reviewed comprehensively, emphasizing their role in drug development from 1977 to 2024.

01 Aug 2024·Drugs

Paracetamol Combination Therapy for Back Pain and Osteoarthritis: A Systematic Review and Meta-Analyses

Review

Author: Illangamudalige, Sandalika ; McLachlan, Andrew J ; Lin, Chung-Wei Christine ; Patanwala, Asad E ; March, Lyn ; Shaheed, Christina Abdel ; Chen, Lingxiao ; Cao, Zhiying ; Han, Kaiyue ; Ferreira, Manuela L ; Lu, Hanting ; Mathieson, Stephanie ; Maher, Christopher G

BACKGROUND AND OBJECTIVEAlthough paracetamol (acetaminophen) combined with other analgesics can reduce pain intensity in some pain conditions, its effectiveness in managing low back pain and osteoarthritis is unclear. This systematic review investigated whether paracetamol combination therapy is more effective and safer than monotherapy or placebo in low back pain and osteoarthritis.METHODSOnline database searches were conducted for randomised trials that evaluated paracetamol combined with another analgesic compared to a placebo or the non-paracetamol ingredient in the combination (monotherapy) in low back pain and osteoarthritis. The primary outcome was a change in pain. Secondary outcomes were (serious) adverse events, changes in disability and quality of life. Follow-up was immediate (≤ 2 weeks), short (> 2 weeks but ≤ 3 months), intermediate (> 3 months but < 12 months) or long term (≥ 12 months). A random-effects meta-analysis was conducted. Risk of bias was assessed using the original Cochrane tool, and quality of evidence using Grading of Recommendations Assessment, Development and Evaluation (GRADE).RESULTSTwenty-two studies were included. Pain was reduced with oral paracetamol plus a non-steroidal anti-inflammatory drug (NSAID) at immediate term in low back pain (paracetamol plus ibuprofen vs ibuprofen [mean difference (MD) - 6.2, 95% confidence interval (CI) -10.4 to -2.0, moderate evidence]) and in osteoarthritis (paracetamol plus aceclofenac vs aceclofenac [MD - 4.7, 95% CI - 8.3 to - 1.2, moderate certainty evidence] and paracetamol plus etodolac vs etodolac [MD - 15.1, 95% CI - 18.5 to - 11.8; moderate certainty evidence]). Paracetamol plus oral tramadol reduced pain compared with placebo at intermediate term for low back pain (MD - 11.7, 95% CI - 19.2 to - 4.3; very low certainty evidence) and osteoarthritis (MD - 6.8, 95% CI - 12.7 to -0.9; moderate certainty evidence). Disability scores improved in half the comparisons. Quality of life was infrequently measured. All paracetamol plus NSAID combinations did not increase the risk of adverse events compared to NSAID monotherapy.CONCLUSIONSLow-to-moderate quality evidence supports the oral use of some paracetamol plus NSAID combinations for short-term pain relief with no increased risk of harm for low back pain and osteoarthritis compared to its non-paracetamol monotherapy comparator.

01 Jun 2024·Die Pharmazie

Association of non-steroidal anti-inflammatory drug use with encephalopathy development: An analysis using the United States Food and Drug Administration Adverse Event Reporting System (FAERS) and Japanese Adverse Drug Event Report (JADER) databases.

Article

Author: Yoshioka, T ; Hayashi, T ; Fukuda, H ; Goda, M ; Kawada, K ; Ishida, T ; Ishizawa, K

Encephalopathy is the most severe complication of various common infections, including influenza and herpes, and it often results in death or severe neurological disability. The risk factors for viral encephalopathy include non-steroidal anti-inflammatory drug (NSAID) use; however, studies on NSAID-related encephalopathy are limited. In this study, we aimed to investigate the characteristics of NSAID-related encephalopathy. We investigated the incidence of NSAID-related encephalopathy using data from the United States Food and Drug Administration Adverse Event Reporting System (FAERS) and Japanese Adverse Drug Event Report (JADER) databases containing reports on spontaneous adverse effects (AEs) published by the Pharmaceuticals and Medical Devices Agency. We used these databases to detect AEs based on reported odds ratios. By separating suspicious drugs, concomitant drugs, and drug interactions involving NSAIDs, we investigated the relationship between encephalopathy pathology and AEs of NSAIDs. Significant encephalopathy signals were detected for loxoprofen and etodolac in the FAERS database and loxoprofen in the JADER database. In the JADER database, significant encephalopathy signals in loxoprofen-treated patients were detected in 70-79-year-old, ≥80-year-old, influenza viral infection, and herpes virus infection groups. Significant encephalopathy signals in patients with herpes virus infection were detected in the ≥80-year-old and loxoprofen-treated groups. Regarding the involvement of loxoprofen in the development of encephalopathy, the JADER database listed loxoprofen as a suspect drug, without indicating any concomitant drug interactions. In conclusion, our findings suggest that loxoprofen and etodolac may be associated with viral encephalopathy. Accordingly, prudence is recommended when using loxoprofen in older individuals with viral infections.

News (Medical) associated with Etodolac

15 Nov 2021

·www.biospace.com

Bayshore Pharmaceuticals Announces Commercial Launch of ANDA Approved Products

Nov. 15, 2021 11:00 UTC SHORT HILLS, N.J.--(BUSINESS WIRE)-- Bayshore Pharmaceuticals, LLC is pleased to introduce three new FDA-approved products to their expanding portfolio. Metolazone Tablets USP, 2.5mg, 5mg and 10 mg, is the generic equivalent of Zaroxolyn Tablets. It is available by prescription only and is indicated for the treatment of high blood pressure and fluid retention. Etodolac Immediate Release Tablets USP, 400 mg and 500 mg, is the generic equivalent of Lodine Tablets. Etodolac is a nonsteroidal anti-inflammatory drug and only available by prescription. Ketotifen Fumarate Ophthalmic Solution, 0.035% (OTC & RX) is the generic equivalent of Zaditor. It is an antihistamine that is indicated for the treatment of itchy eyes. Ketotifen is Bayshore Pharmaceutical’s first ANDA approved product that is available by prescription or as an OTC in the Bayshore Label. “Bayshore is very proud to bring these internal R&D projects through to FDA approval and commercialization. These efforts further exemplify our focus on balancing internally developed products with our continued partnerships with manufacturing partners such as Beximco Pharmaceuticals, in which we can utilize our trade relationships to market & distribute ANDA’s for those companies not set up do so directly,” says Mark Moshier, President of Bayshore Pharmaceuticals. About Bayshore Pharmaceuticals: Bayshore Pharmaceuticals, LLC was established in 2011 in the centrally located area of Short Hills, NJ. As a full-service Sales & Distribution company focusing on FDA-approved generic pharmaceuticals, Bayshore used its extensive knowledge and experience in global API and Finished Dosage Form manufacturing to differentiate itself from other Generic Pharmaceutical Sales & Marketing organizations. In addition to developing its wholly-owned portfolio of generic products, Bayshore successfully utilized its longstanding industry relationships to augment its business by marketing other pharma manufacturer’s ANDA products under the same Bayshore label. With a strong emphasis on Project Management and Supplier & Customer transparency, Bayshore, along with our global manufacturing partners, maintains the highest level of product quality, in full compliance with current Good Manufacturing Practices (cGMP). This mission has allowed Bayshore to become one of the most service-oriented and reliable supply partners in the industry. View source version on businesswire.com: Contacts Mark Moshier, President (973) 315-1819 Dena Mando, Vice President Sales & Marketing (973) 315-1824 Source: Bayshore Pharmaceuticals View this news release online at:

04 Oct 2021

·endpts.com

Three generic firms shell out $447M more to settle federal price fixing allegations

Generic drug firms Taro Pharmaceuticals USA, Novartis’ Sandoz, and Apotex have agreed with the US Department of Justice to pay $447.2 million on top of the more than $400 million in criminal penalties they already paid to resolve alleged violations that they illegally collaborated on price, supply and allocation of customers with other pharma manufacturers. Each of the companies entered a five-year corporate integrity agreement, which includes internal monitoring and price transparency provisions, among other checks and balances. New York-based Taro will pay almost half of that latest sum, or $213.2 million, for alleged violations involving the nonsteroidal drug etodolac, and nystatin-triamcinolone cream and ointment to treat skin infections. Sandoz agreed to pay $185 million related to alleged issues with benazepril HCTZ, used to treat hypertension, and clobetasol, a corticosteroid used to treat skin conditions. “The conduct at issue here occurred at Sandoz from March 2013 through December 2015 in direct contravention of the company’s values, policies and trainings in place at the time. The individuals implicated in the underlying conduct are no longer employed by the company,” Sandoz said in a statement. And Florida-based Apotex agreed to pay $49 million in connection with its sale of pravastatin, a drug used to treat high cholesterol and triglyceride levels. Apotex is also part of another ongoing investigation involving pravastatin price-fixing allegations, involving Teva Pharmaceuticals and Glenmark Pharmaceuticals. This latest $447 million payout also follows the payment of separate criminal penalties, in which Taro paid $205.6 million and admitted to conspiring with two other generic drug companies to fix prices on certain generic drugs, while Sandoz paid another $195 million and admitted to conspiring with four other generic drug companies to fix prices on certain generic drugs, and Apotex paid $24.1 million and admitted to conspiring to increase and maintain the price on pravastatin.

Generic DrugCollaborate

100 Deals associated with Etodolac

External Link

KEGG	Wiki	ATC	Drug Bank
D00315	Etodolac	M01AB08	DB00749

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
Analgesia	JP	ASKA Pharmaceutical Co., Ltd.	01 Jul 1994
Inflammation	JP	Nippon Shinyaku Co., Ltd.	01 Jul 1994
Inflammation	JP	ASKA Pharmaceutical Co., Ltd.	01 Jul 1994
Pain	JP	Nippon Shinyaku Co., Ltd.	01 Jul 1994

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Burkitt Lymphoma	Preclinical	JP	Hamamatsu University School of Medicine	16 Nov 2005
Multiple Myeloma	Preclinical	JP	Hamamatsu University School of Medicine	16 Nov 2004

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


ASCO2014	Not Applicable	Glioblastoma	32	Metronomic temozolamide	(fucomtgatk) = prrsqicybo woicvubcuu (jpwmsoyhzk ) View more	Positive	20 May 2014
				Metronomic temozolamide + Propranolol + Etodolac	(fucomtgatk) = buizssoqwo woicvubcuu (jpwmsoyhzk ) View more

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