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Lodine

(Etodolac)

Phase 3Small molecule

WWyeth-Lederle Vaccines

Lodine is one of 64 small molecule programs targeting Ovarian Cancer. It is currently in Phase 3.

3

Indications

10

Total Trials

1

Active Trials

63

Competitors

2

FDA Applications

NDA/BLA/ANDA regulatory filings

Pipeline

Status by Indication[3][1]

Indication

Ovarian CancerActive, not recruiting

MyalgiaActive, not recruiting

SprainActive, not recruiting

Ovarian CancerPreclinical

Active, not recruiting

MyalgiaPreclinical

Active, not recruiting

SprainPhase 3

Active, not recruiting

Competition

Competitive Landscape

836 competitors in Ovarian Cancer

#DrugCompanyPhaseTrials

Imfinzi

Adriamycin

Platinol

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

Zepzelca

Jazz Pharmaceuticals

Vepesid

Veliparib

Single Dose of

Boehringer Ingelheim

Lodine

WWyeth-Lederle Vaccines

Azenosertib

KK-Group Alpha, Inc., a wholly owned subsidiary of Zentalis Pharmaceuticals, Inc.

JSKN003

JJiangsu Alphamab Biopharmaceuticals Co., Ltd

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 Extended Release Tablets USP 600mg Under Fed Condition

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

Bioequivalence Study of Etodolac Capsules USP 300 mg Under Fed Condition

Completed·IIPCA Laboratories Ltd.·Phase 1·NCT01749228·36 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 Control1 trial

Phase III Efficacy and Tolerability Trial of the Fixed Dose Combination of Etodolac 400 mg and Cyclobenzaprine 10 mg Versus Isolated Active Substances in Pain Control After Impacted Third Molar Extraction

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

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

Etodolac and Post-bleaching Sensitivity

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

Bioequivalence Study of Etodolac Capsules USP 300 mg Under Fasting Condition

Completed·IIPCA Laboratories Ltd.·Phase 1·NCT01746719·36 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: Phase 3[1]
Company: WWyeth-Lederle Vaccines

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