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Toradol

(Ketorolac Tromethamine)

ApprovedSmall molecule

Ketorolac is a strong pain reliever used to treat moderate to severe pain, usually for short-term use after surgery or injury. It works by reducing inflammation and blocking pain signals in the body.[2] Toradol is currently approved and in use across 21 indications[4].[1]

Toradol is one of 398 small molecule programs targeting Cataract. It is currently in Approved.

21

Indications

62

Total Trials

6

Active Trials

397

Competitors

8

FDA Applications

NDA/BLA/ANDA regulatory filings

5

Patents

Pipeline

Status by Indication[4][1]

Indication

CataractActive, not recruiting

Renal Cell CarcinomaActive, not recruiting

Cystoid Macular EdemaActive, not recruiting

Ocular PainActive, not recruiting

NephrolithiasisApproved

Migraine DisorderApproved

Shoulder Impingement SyndromeApproved

PulpitisApproved

Macular Retinal EdemaApproved

OsteoarthritisActive, not recruiting

CataractApproved

Active, not recruiting

Renal Cell CarcinomaPreclinical

Active, not recruiting

Cystoid Macular EdemaPreclinical

Active, not recruiting

Ocular PainApproved

Active, not recruiting

NephrolithiasisApproved

Approved

Migraine DisorderApproved

Approved

Shoulder Impingement SyndromeApproved

Approved

PulpitisApproved

Approved

Macular Retinal EdemaApproved

Approved

OsteoarthritisPreclinical

Active, not recruiting

Showing 10 of 20 indications

Competition

Competitive Landscape

143 competitors in Osteoarthritis

#DrugCompanyPhaseTrials

Toradol

Cataflam

Enbrel

Glucophage

Precedex

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

Protonix

WWyeth-Lederle Vaccines

Catapres

Boehringer Ingelheim

MS Contin

HHikma Pharmaceuticals LLC

Chirocaine

PPurdue Pharma LP

Lunesta

Akero Therapeutics

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

Timeline

Expected Milestones

Q4 2026

Phase 1Active, not recruiting

Pancreatic Ductal Adenocarcinoma

NCT05336266

Q2 2027

Post-ApprovalRecruiting

Back Pain

NCT06395428

Post-ApprovalRecruiting

Post Operative Pain

NCT06513208

Q3 2027

Anesthesia

NCT03427736

Q4 2027

Phase 1Recruiting

Venous Distension Reflex

NCT03513770

Clinical

Trials by Indication[1]

Ketorolac7 trials

Study to Assess the PK of Ketorolac Tromethamine Intranasal and to Assess the Effects of a Oxymetazoline Hydrochloride on the PK of Ketorolac Tromethamine

Completed·EEgalet Ltd·Phase 1·NCT01363089·21 enrolled

Safety and Pharmacokinetics Study of Intranasal Ketorolac in Elderly and Nonelderly Adult Healthy Subjects

Completed·AAmerican Regent, Inc.·Phase 1·NCT01365624·30 enrolled

Assessment of Nasal Deposition and Clearance of Ketorolac Solution Administered Using the Valois Nasal Spray Device

Completed·EEgalet Ltd·Phase 1·NCT01356212·13 enrolled

Show 4 more trials

Open Label Study to Assess the Pharmacokinetics of Intranasal Ketorolac Tromethamine Following Fluticasone Propionate in Healthy Subjects

Completed·EEgalet Ltd·Phase 1·NCT01365611·36 enrolled

A Comparison of Prostaglandin E2 (PGE2) Inhibition of Acuvail(Ketorolac 0.45%), Xibrom (Bromfenac 0.09%)and Nevanac (Nepafenac)in Patients Undergoing Phacoemulsification

Completed·FFrank A. Bucci, Jr., M.D.·Phase 4·NCT01021761·126 enrolled

Study of Whether 15 mg Dose of Ketorolac IV is as Effective as a 30 mg Dose.

Unknown status·UUniversity of Calgary·N/A·NCT01230463·50 enrolled

Tolerability, Safety and Pharmacokinetics of Four Formulations of Ketorolac Tromethamine in Healthy Volunteers

Completed·EEgalet Ltd·Phase 1·NCT01355588·16 enrolled

Post Operative Pain4 trials

The Pharmacokinetics of Ketorolac Tromethamine Administered Intranasally (IN) for Postoperative Pain in Children Aged 12 Through 17 Years

Completed·EEgalet Ltd·Phase 1·NCT01363076·20 enrolled

Study of the Safety, Tolerability and Analgesic Efficacy of Multiple Doses of Ketorolac Tromethamine (IN) for Postoperative Pain

Completed·AAmerican Regent, Inc.·Phase 2·NCT01351090·127 enrolled

Ketorolac Effects on Post-operative Pain and Lumbar Fusion

Recruiting·—·Phase 4·NCT06513208·140 enrolled

Show 1 more trial

Ketorolac Applied by Continuous IV Infusion for Treatment of Moderately Severe Postoperative Pain Following Bunionectomy

Completed·NNeumentum, Inc.·Phase 3·NCT05324358·341 enrolled

Premedication3 trials

Effect of Premedication on Success of Inferior Alveolar Nerve Block Injection

Completed·—·Phase 2·NCT02601911·60 enrolled

Premedication Efficacy of Ketorolac Infiltration on Post Endodontic Pain

Completed·—·Phase 2·NCT02923687·60 enrolled

Premedication Efficacy of Oral Ketorolac and Ketorolac/ Acetaminophen on Post Treatment Pain

Completed·—·Phase 2·NCT02614118·66 enrolled

Back pain3 trials

Comparison Of Ketorolac Tromethamine Oral Drops Versus Naproxen For Moderate to Severe Back Pain Treatment

Completed·EEMS·Phase 3·NCT01471899·78 enrolled

Comparison Of Ketorolac Tromethamine Versus Naproxen For Moderate to Severe Back Pain Treatment

Completed·EEMS·Phase 3·NCT01471886·83 enrolled

Haloperidol for Pain Control in Patients With Acute Musculoskeletal Back Pain in the Emergency Department

Recruiting·—·Phase 4·NCT06395428·75 enrolled

Intravenous2 trials

A Pharmacokinetic Study of Intravenous NTM-001 in Healthy Chinese Subjects

Completed·NNuance Pharma (shanghai) Co., Ltd·Phase 1·NCT05382546·16 enrolled

Disposition of Intravenous Ketorolac

Completed·UUniversitaire Ziekenhuizen KU Leuven·Phase 4·NCT01291472·42 enrolled

38 more indications

Safety and Efficacy2 trials

Safety and Efficacy Study of KAI-1678 to Treat Subjects With Postoperative Pain

Completed·KKAI Pharmaceuticals·Phase 2·NCT01015235·90 enrolled

Safety and Efficacy of Multiple Doses of Ketorolac Tromethamine Administered Intranasally for Postoperative Pain

Completed·EEgalet Ltd·Phase 3·NCT01347853·300 enrolled

Migraine2 trials

Efficacy and Safety of Intranasal Ketorolac for the Acute Treatment of Migraine

Completed·EEgalet Ltd·Phase 2·NCT00483717·173 enrolled

Intravenous Ketorolac and Metoclopramide for Pediatric Migraine in the Emergency Department

Completed·UUniversity of Alberta·Phase 4·NCT01596166·56 enrolled

Treatment2 trials

A Single-dose Study of Intranasal Ketorolac in the Treatment of Pain Secondary to Dental Impaction Surgery

Completed·EEgalet Ltd·Phase 2·NCT01356225·80 enrolled

Treatment of Topical Ketorolac Gel in Acute Gouty Flare

Unknown status·NNovilla Pharmaceuticals·Phase 1·NCT06273813·30 enrolled

Intranasal Administration2 trials

Study of the Tolerability of Ketorolac Tromethamine Following Intranasal Administration in Healthy Volunteers

Completed·EEgalet Ltd·Phase 1·NCT01363063·40 enrolled

Study to Determine the Tolerability, Safety and Pharmacokinetics of Ketorolac Tromethamine by Intranasal Administration in Healthy Volunteers

Completed·EEgalet Ltd·Phase 1·NCT01363050·15 enrolled

Hysterectomy2 trials

Pre-operative Ketorolac Administration Has no Pre-emptive Analgesic Effect Following Total Abdominal Hysterectomy

Completed·—·Phase 4·NCT02642718·48 enrolled

Wound Infiltration With Ketorolac Versus Lidocaine for Postoperative Analgesia After Total Abdominal Hysterectomy

Unknown status·—·Phase 4·NCT03394001·80 enrolled

Pain Management1 trial

Intranasal Ketorolac Tromethamine (SPRIX) as a Short Term Pain Management of Post-Vasectomy Pain

Unknown status·CCitrus Valley Medical Research, Inc.·Phase 4·NCT02000388·15 enrolled

Osteoarthritis1 trial

Ketorolac Versus Triamcinolone Knee Injections for Osteoarthritis

Completed·SSan Antonio Military Medical Center·N/A·NCT02295189·36 enrolled

Infiltration1 trial

Efficacy of Ketorolac Buccal Infiltration on Success Rate of Inferior Alveolar Nerve Block

Completed·NNahid Mohammadzadeh Akhlaghi·Phase 2·NCT02536430·40 enrolled

Proliferative Diabetic Retinopathy1 trial

Topic Ketorolac Added to Panphotocoagulation in Proliferative Diabetic Retinopathy

Completed·HHospital Juarez de Mexico·Phase 2·NCT00907114·44 enrolled

Breast Surgery1 trial

Toradol (Ketorolac) in Breast Surgery to Reduce Pain & Opioid Use

Completed·CCarilion Clinic·Phase 1·NCT04439396·183 enrolled

Efficacy and Safety1 trial

Efficacy and Safety of Escócia Association in the Treatment of Acute Pain

Withdrawn·EEMS·Phase 2·NCT04666701

Pancreatic Ductal Adenocarcinoma1 trial

A Feasibility Study of Ketorolac Treatment for Cachexia in Patients With Advanced Pancreatic Ductal Adenocarcinoma

Active, not recruiting·—·Phase 1·NCT05336266·28 enrolled

Cataract1 trial

Comparison of Topical Ketorolac 0,4% Versus Placebo in Cataract Surgery

Completed·UUniversity of Campinas, Brazil·Phase 4·NCT01542190·80 enrolled

Radius Fracture1 trial

Pain Outcomes of Intra-operative IV Tylenol and/or IV Toradol for Carpal Tunnel and Distal Radius Fracture Surgeries

Completed·JJohn Fowler·Phase 4·NCT02313675·44 enrolled

Abdominal pain1 trial

Intravenous Ketorolac Vs. Morphine In Children With Acute Abdominal Pain

Recruiting·UUniversity of Calgary·Phase 3·NCT06160778·495 enrolled

Dental Pain1 trial

Efficacy of Block Injection of an Anti Inflammatory Medicine in Patients With Mandibular Dental Pain

Completed·—·Phase 2·NCT03410212·60 enrolled

Intravenous Lidocaine1 trial

Intravenous Lidocaine and Ketorolac for Pain Management

Completed·AAntonios Likourezos·Phase 4·NCT02902770·150 enrolled

Renal Colic1 trial

Atomized Intranasal Vs Intravenous Ketorolac in Acute Renal Colic Pain Management.

Completed·OOman Medical Speciality Board·Phase 2/3·NCT04441762·171 enrolled

Immune Response1 trial

Effect of Morphine, Tramadol, and Ketorolac on Postoperative Stress and Immune Responses

Unknown status·—·Phase 2/3·NCT02449954·60 enrolled

RCT1 trial

Knee Injection RCT

Terminated·UUConn Health·Phase 4·NCT03694821·18 enrolled

Interaction1 trial

Administration of Tramadol and Ketorolac Separately and Simultaneously to Assess a Potential Pharmacokinetic Interaction

Completed·GGrünenthal GmbH·Phase 1·NCT03767036·30 enrolled

Pediatric Patients1 trial

Ketorolac Use in Pediatric Patients Undergoing Tonsillectomy

Terminated·—·Phase 4·NCT03453541·214 enrolled

Pulpitis1 trial

Ketorolac Premedication for Anesthetic Efficiency of IANB & Postendodontic Pain in Teeth With Irreversible Pulpitis

Unknown status·—·N/A·NCT02940405·38 enrolled

Acute Pain1 trial

Comparison of Ketorolac at Three Doses in Children With Acute Pain

Completed·HHamilton Health Sciences Corporation·Phase 3·NCT05641363·171 enrolled

Total Hip Arthroplasty1 trial

Psoas Compartment Block Versus Periarticular Local Anesthetic for Total Hip Arthroplasty

Completed·CCorewell Health East·Phase 4·NCT02658149·100 enrolled

Pain Control1 trial

Preoperative Ketorolac for Pain Control in Scleral Buckle Surgery

Completed·SSun Yat-sen University·Phase 4·NCT02729285·73 enrolled

Breast Reconstruction1 trial

Ketorolac for Analgesia followiNG Autologous Breast RecOnstructiOn

Withdrawn·NNova Scotia Health Authority·Phase 4·NCT03007381

Methylprednisolone1 trial

Subacromial Methylprednisolone Versus Ketorolac for Shoulder Impingement

Terminated·TThe University of Texas Medical Branch, Galveston·Phase 2·NCT03913702·1 enrolled

Interstitial Cystitis1 trial

Intranasal Ketorolac Tromethamine (Sprix) for Acute Pain of Interstitial Cystitis Flare of Pain

Completed·CCitrus Valley Medical Research, Inc.·Phase 4·NCT02000401·15 enrolled

Laparoscopic Surgery1 trial

Efficacy, Safety and Tolerability Study of N1539 in Subjects After Abdominal Laparoscopic Surgery

Terminated·AAlkermes, Inc.·Phase 3·NCT01436032·50 enrolled

Analgesic Efficacy1 trial

The Analgesic Efficacy of Magnesium and Ketorolac in Ultrasound Supraclavicular Block

Completed·FFayoum University Hospital·Phase 4·NCT04554862·80 enrolled

Low back pain1 trial

Ketorol Gel in Gonarthrosis and Low Back Pain

Completed·—·Phase 4·NCT02638831·240 enrolled

Allergic Rhinitis1 trial

Study to Assess the Absorption and Tolerability of Intranasal Ketorolac Tromethamine and to Assess the Effects of Oxymetazoline Hydrochloride and Fluticasone Propionate on the Absorption and Tolerability of Intranasal Ketorolac Tromethamine in Participants With Allergic Rhinitis

Completed·EEgalet Ltd·Phase 1·NCT01365650·24 enrolled

Periodontitis1 trial

Evaluation of Post-operative Pain and Expression of IL-8 Using Ketolac or Cryoirrigation as a Final Flush in Single Visit Endodontic Treatment in Teeth With Symptomatic Irreversible Pulpitis and Apical Periodontitis.Randomized Clinical Trial.

Completed·—·Phase 1·NCT04733326·48 enrolled

Prostatectomy1 trial

Opioid-Free Pain Control Regiment Following Robotic Radical Prostatectomy

Withdrawn·WWake Forest University Health Sciences·Phase 2/3·NCT04939987

Chronic Knee Pain1 trial

Radiofrequency Neurotomy In Relieving Chronic Knee Pain

Completed·—·N/A·NCT03224637·60 enrolled

Anesthesia1 trial

Pharmacokinetics of Anesthetics and Analgesics in Children and Adolescent

Recruiting·CChi Dang Hornik··NCT03427736·551 enrolled

Venous Distension Reflex1 trial

Autonomic Control of the Circulation and the Venous Distension Reflex

Recruiting·MMilton S. Hershey Medical Center·Phase 1·NCT03513770·18 enrolled

Regulatory

FDA Approval Timeline[5]

Jan 1, 1982

THAM

NDA NDA013025

Nov 30, 1989

TORADOL

NDA NDA019698

Dec 20, 1991

TORADOL

NDA NDA019645

Nov 9, 1992

ACULAR

NDA NDA019700

Nov 3, 1997

ACULAR PRESERVATIVE FREE

NDA NDA020811

May 30, 2003

ACULAR LS

NDA NDA021528

Jul 22, 2009

ACUVAIL

NDA NDA022427

May 14, 2010

SPRIX

NDA NDA022382

Sources

References

[1]
ClinicalTrials.gov — 62 trial records for Ketorolac Tromethamine. U.S. National Library of Medicine, National Institutes of Health.
[2]
MedlinePlus Drug Information — Toradol drug information. U.S. National Library of Medicine, National Institutes of Health.
[3]
ChEMBL — Ketorolac Tromethamine compound record. European Bioinformatics Institute (EMBL-EBI).
[4]
Open Targets Platform — Drug–disease associations for Ketorolac Tromethamine. EMBL-EBI & Wellcome Sanger Institute.
[5]
OpenFDA — FDA approval records (NDA NDA022382). U.S. Food & Drug Administration.
[6]
FDA Orange Book — Patent and exclusivity data for Toradol. U.S. Food & Drug Administration.
[7]
SEC EDGAR — Roche company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: Cyclooxygenase Inhibitor[3]
Modality: Small molecule[3]
Highest Phase: Approved[1]
Company: Roche

Patent Landscape[6]

Patent Cliff

May 24, 2027

Earliest patent expiration — generic entry possible after this date

Patent #Expires

8008338May 24, 2027

8008338*PEDNov 24, 2027

8512717Mar 7, 2028

9192571Mar 7, 2028

7842714Aug 15, 2029

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