Lodine

(Etodolac)

PreclinicalSmall molecule

WWyeth-Lederle Vaccines

Lodine is one of 65 small molecule programs targeting Ovarian Cancer. It is currently in Preclinical.

Indications

Total Trials

Active Trials

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Pipeline

Status by Indication[3][1]

Indication

Ovarian CancerRecruiting

MyalgiaActive, not recruiting

Ovarian CancerPreclinical

Recruiting

MyalgiaPreclinical

Active, not recruiting

Competition

Competitive Landscape

207 competitors in Ovarian Cancer

#DrugCompanyPhaseTrials

Avastin

Roche

Phase 3

92 2

Gemzar

Johnson & Johnson

Phase 3

33 3

Hycamtin

MMeitheal

Phase 3

26 4

Pegylated Liposomal Doxorubicin

Merck & Co.

Phase 3

35 5

Platinol

MMcNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.

Phase 3

24 6

Imfinzi

AstraZeneca

Phase 3

8 7

Opdivo

Bristol-Myers Squibb

Phase 3

8 8

Adriamycin

Pfizer

Phase 3

8 9

Rubraca

Bristol-Myers Squibb

Phase 3

6 10

Herceptin

Roche

Phase 3

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

Timeline

Expected Milestones

Q2 2027

PreclinicalRecruiting

Ovarian Cancer

NCT05429970

Clinical

Trials by Indication[1]

Fed2 trials

Bioequivalence Study of Etodolac Capsules USP 300 mg Under Fed Condition

Completed·IIPCA Laboratories Ltd.·Phase 1·NCT01749228·36 enrolled

Bioequivalence Study of Etodolac Extended Release Tablets USP 600mg Under Fed Condition

Completed·IIPCA Laboratories Ltd.·Phase 1·NCT01831687·36 enrolled

Post Operative Pain1 trial

A Study to Verify the Efficacy of YM177 (Celecoxib) in Postoperative Pain Patients

Completed· Astellas logo

Astellas·Phase 3·NCT01118572·616 enrolled

Sprain1 trial

MRX-7EAT Etodolac-Lidocaine Topical Patch in the Treatment of Ankle Sprains

Completed·MMEDRx USA, Inc.·Phase 3·NCT01198834·600 enrolled

Myalgia1 trial

Evaluation of the Effects of Treatments Applied to Patients With Facial Myalgia on Occlusion Parameters

Completed·YYuzuncu Yil University·N/A·NCT05261971·60 enrolled

Pain, Acute1 trial

Phase III Randomized, Unicentric, Double-masked, Parallel Trial for the Efficacy and Tolerability of the Fixed Dose Combination of Etodolac 400 mg and Cyclobenzaprine 10 mg Versus the Isolated Active Substances (Flancox® 400 mg And Miosan® 10 mg) in Postoperative Pain Control After Impacted Third Molar Extraction

Terminated·AApsen Farmaceutica S.A.·Phase 3·NCT03127592·140 enrolled

2 more indications

Ovarian Cancer1 trial

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

Recruiting·MMemorial Sloan Kettering Cancer Center·Preclinical·NCT05429970·35 enrolled

Unspecified3 trials

Bioequivalence Study of Etodolac Capsules USP 300 mg Under Fasting Condition

Completed·IIPCA Laboratories Ltd.·Phase 1·NCT01746719·36 enrolled

Etodolac and Post-bleaching Sensitivity

Completed·FFlavia Pardo Salata Nahsan·Phase 4·NCT02881619·50 enrolled

Bioequivalence Study of Etodolac Extended Release Tablets USP 600mg Under Fasting Condition

Completed·IIPCA Laboratories Ltd.·Phase 1·NCT01827865·36 enrolled

Regulatory

FDA Approval Timeline[4]

Jan 31, 1991

LODINE

NDA NDA018922

Oct 25, 1996

LODINE XL

NDA NDA020584

Sources

References

[1]
ClinicalTrials.gov — 10 trial records for Etodolac. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Etodolac compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Etodolac. EMBL-EBI & Wellcome Sanger Institute.
[4]
OpenFDA — FDA approval records (NDA NDA020584). U.S. Food & Drug Administration.
[5]
SEC EDGAR — Wyeth-Lederle Vaccines company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Highest Phase: Preclinical[1]
Company: WWyeth-Lederle Vaccines

Lodine

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q2 2027

Trials by Indication[1]

Fed2 trials

Post Operative Pain1 trial

Sprain1 trial

Myalgia1 trial

Pain, Acute1 trial

Ovarian Cancer1 trial

Unspecified3 trials

FDA Approval Timeline[4]

References

Drug Info

Quick Facts

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