Oruvail

(Ketoprofen)

ApprovedSmall molecule

Oruvail is a small molecule that works as a Cyclooxygenase Inhibitor.[2] It is being used across 25 indications, with its most advanced program in Approved.[1]

Oruvail is one of 481 small molecule programs targeting Low back pain. It is currently in Approved.

Indications

Total Trials

Active Trials

480

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Pipeline

Status by Indication[3][1]

Indication

Low Back PainApproved

Post Operative Nausea and VomitingApproved

Migraine DisorderApproved

Rheumatic DiseaseActive, not recruiting

AbortionActive, not recruiting

TendinitisApproved

DysmenorrheaActive, not recruiting

ArthralgiaActive, not recruiting

Renal ColicApproved

FibrosisActive, not recruiting

Low Back PainApproved

Approved

Post Operative Nausea and VomitingApproved

Approved

Migraine DisorderApproved

Approved

Rheumatic DiseaseApproved

Active, not recruiting

AbortionPreclinical

Active, not recruiting

TendinitisApproved

Approved

DysmenorrheaApproved

Active, not recruiting

ArthralgiaApproved

Active, not recruiting

Renal ColicApproved

Approved

FibrosisPhase 2

Active, not recruiting

Showing 10 of 24 indications

Competition

Competitive Landscape

791 competitors in Rheumatoid Arthritis

#DrugCompanyPhaseTrials

Oruvail

WWyeth-Lederle Vaccines

Approved

44 2

Rituxan

Roche

Preclinical

61 3

Orencia

Bristol-Myers Squibb

Preclinical

47 4

Actemra

Cimzia

30 6

Simponi

Johnson & Johnson

Preclinical

19 7

Enbrel

IImmunex

Preclinical

64 8

Remicade

OOrganon and Co

Preclinical

43 9

Arcoxia

Novartis

Preclinical

4 10

Kevzara

AAzienda U.S.L. 1 di Massa e Carrara

Preclinical

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

Timeline

Expected Milestones

Q3 2027

Phase 3Recruiting

Cardiac Surgery

NCT06381063

Q4 2028

Phase 2Recruiting

Non-Steroidal Anti-Inflammatory Drugs

NCT06731647

Q1 2033

Phase 2Recruiting

Fibrosis

NCT06912763

Clinical

Trials by Indication[1]

Osteoarthritis3 trials

A Long-Term Safety Study of IDEA-033 in Comparison to Oral Naproxen for the Treatment of Osteoarthritis of the Knee

Completed·IIDEA AG·Phase 2·NCT00265304·550 enrolled

Novel Transdermal Ketoprofen Gel Formulation for Knee Osteoarthritis

Active, not recruiting·NNew Valley University·Phase 1·NCT07319728·40 enrolled

HKT-500 in Adult Patients With Osteoarthritis (OA) Knee Pain

Completed·HHisamitsu Pharmaceutical Co., Inc.·Phase 3·NCT00792727·380 enrolled

Lymphedema3 trials

Lymphedema Study for Arm or Leg Lymphedema

Completed·SStanford University·Phase 4·NCT02257970·117 enrolled

Characterization of Treatment Responses in Lymphedema

Terminated·SStanford University··NCT03783715·2 enrolled

Lymphedema Treatment Registry

Unknown status·—··NCT04272372·60 enrolled

Sprain3 trials

Ketoprofen Gel vs Placebo in Children With Ankle Sprain

Unknown status·—·Phase 4·NCT02491736·100 enrolled

Topical Ketoprofen Versus Placebo in Patients With Ankle Sprain

Completed·—·Phase 4·NCT02393846·100 enrolled

HKT-500 in the Treatment of Adult Patients With Ankle Sprain

Completed·HHisamitsu Pharmaceutical Co., Inc.·Phase 3·NCT00927641·240 enrolled

Migraine3 trials

Trial on Metoclopramide and Ketoprofen in Acute Migraine of Childhood

Withdrawn·IIRCCS Burlo Garofolo·Phase 3·NCT00557544

Efficacy of CLORazepate for the Treatment of MIGraine Attack in the Emergency Room

Terminated·AAssistance Publique - Hôpitaux de Paris·Phase 3·NCT04726592·323 enrolled

Ginger Capsules for the Acute Treatment of Migraine Attacks

Completed·FFederal University of Minas Gerais·N/A·NCT02568644·60 enrolled

Treatment2 trials

Sphenopalatine Blockade Versus Clinical Treatment

Unknown status·UUniversity of Sao Paulo General Hospital·N/A·NCT04148846·45 enrolled

Novel Topical Therapies for the Treatment of Genital Pain

Completed·UUniversity of Rochester·Phase 2/3·NCT02099006·9 enrolled

25 more indications

Low back pain2 trials

Ketoprofen Gel vs Placebo in Low Back Pain

Unknown status·—·Phase 4·NCT02491879·100 enrolled

Ketorol Gel in Gonarthrosis and Low Back Pain

Completed·—·Phase 4·NCT02638831·240 enrolled

Efficacy2 trials

Efficacy of Ketoprofen Before Hysterosalpingography

Completed·—·Phase 3·NCT02905045·100 enrolled

Efficacy of Ketoprofen Before Intrauterine Device Insertion

Completed·—·Phase 3·NCT02905058·100 enrolled

Cesarean Section2 trials

Comparison of Two Pain-treatment Techniques After Cesarean Section

Completed·MMichał Borys·Phase 4·NCT02804126·232 enrolled

Regional Analgesia After Cesarean Section

Completed·MMedical University of Lublin·Phase 4·NCT03244540·105 enrolled

Efficacy and Safety2 trials

Trauma Acute Pain Treatment With Methoxyflurane Vaporized (PENTHROX®): Efficacy and Safety Study (MEDITA)

Completed·MMundipharma Pharmaceuticals srl·Phase 3·NCT03585374·272 enrolled

A Study to Assess Efficacy and Safety of the Ketoprofen vs Diclofenac

Completed·HHandok Inc.·Phase 3·NCT04421911·236 enrolled

Renal Colic2 trials

Efficacy And Safety Of Parecoxib 40mg vs. Ketoprofen 100mg In The Management Of Acute Renal Colic

Completed· Pfizer logo

Pfizer·Phase 4·NCT00553605·340 enrolled

Intravenous Paracetamol Versus Ketoprofen When Treating Renal Colic in Emergency Situations

Withdrawn·—·Phase 4·NCT01685658

Postoperative Analgesia1 trial

Non-opioid Analgesic Combination With Morphine for Postoperative Analgesia.

Terminated·RRennes University Hospital·Phase 4·NCT01882530·223 enrolled

Trauma1 trial

Study of Non Inferiority Bi-Profenid® 200mg Versus Bi-Profenid® 300mg Among Patients Presenting of the Post-traumatic or Rheumatologic Acute Affections of the Locomotor Apparatus (BIPROPAIN)

Completed· Sanofi logo

Sanofi·Phase 3·NCT00810121·409 enrolled

Muscle Pain1 trial

Study of Epicutaneously Applied Ketoprofen Transfersome® Gel With or Without Combination With Oral Celecoxib for the Treatment of Muscle Pain Induced by Eccentric Exercise

Completed·XX-pert Med GmbH·Phase 1·NCT01020279·82 enrolled

Tonsillitis1 trial

Evaluation of Inflammatory Symptoms Reduction With Amoxicillin + Ketoprofen in Acute Pharyngeal Tonsillitis in Pediatric Patients

Terminated· Sanofi logo

Sanofi·Phase 4·NCT00799838·106 enrolled

Sciatica1 trial

Safety and Efficacy of Nonsteroidal Antiinflammatory (NSAI)Drug and Glucocorticoids in Acute Sciatica

Completed·UUniversity Hospital, Grenoble·Phase 4·NCT01816334·50 enrolled

Perioperative Pain1 trial

Oxycodone Extended-release in the Treatment of Perioperative Pain in Patients Undergoing Orthopaedic Surgery

Completed·HHospital Central Dr. Luis Ortega·Phase 4·NCT02238340·40 enrolled

Abortion1 trial

Postoperative Pain After Medical Abortion Under Local Anesthesia : Comparison of Several Analgesic Regimen

Completed·UUniversity Hospital, Angers·N/A·NCT00188071·240 enrolled

Cardiac Surgery1 trial

Non-steroidal Anti-inflammatory in Cardiac Surgery

Recruiting·—·Phase 3·NCT06381063·238 enrolled

Third Molar1 trial

Comparison of the Clinical Efficacy of Ketoprofen, Associated or Not With Omeprazole in Lower Third Molar Removal

Completed·LLuis Fernando Simoneti·Phase 4·NCT02730026·50 enrolled

Fibrosis1 trial

Reversing External-beam Radiotherapy-associated Fibrosis Syndrome: an Interventional Bayesian Adaptive Randomized-controlled Orphan Drug Platform Trial for Orodental Sequelae (Reverse-fibrose)

Recruiting·MM.D. Anderson Cancer Center·Phase 2·NCT06912763·250 enrolled

Post Operative Pain1 trial

Intravenous Paracetamol for Postoperative Pain

Completed·LLithuanian University of Health Sciences·Phase 4·NCT02248493·54 enrolled

Multimodal Analgesia1 trial

Dexamethasone, Can it Replace Ketoprofen in the Strategy of Intraoperative Multimodal Analgesia in Paediatric Surgery ? A Prospective Randomized Double-blinded Study. DEXA OP

Completed·RRennes University Hospital·Phase 3·NCT02400047·580 enrolled

Multiple Sclerosis1 trial

PET Imaging of Cyclooxygenase in Multiple Sclerosis

Terminated·NNational Institute of Mental Health (NIMH)·Phase 2·NCT05062083·7 enrolled

Sternotomy1 trial

Reduce Nonsteroidal Antiinflammatory Drugs Doses for Analgesia After Sternotomy

Unknown status·UUniversity Hospital, Clermont-Ferrand·Phase 2·NCT02180087·100 enrolled

Cesarean Delivery1 trial

TAP vs QLB in Patients After Cesarean Delivery

Completed·MMedical University of Lublin·Phase 4·NCT03404908·105 enrolled

Brachytherapy1 trial

Paracetamol With or Without Ketoprofen in the Management of Pain for Patients Receiving Brachytherapy (KETOCOL-1304)

Completed·CCentre Oscar Lambret·Phase 2·NCT02439034·68 enrolled

Pain Management1 trial

Efficacy of Oral Paracetamol Compared With Oral Ketoprofen for Pain Management in Office Hysteroscopy

Completed·IIndonesia University·Phase 4·NCT07315698·60 enrolled

Sore Throat1 trial

KRYSTAL- KetopRofen lYsinate Sore ThroAt Lozenges

Completed· Sanofi logo

Sanofi·Phase 3·NCT00929877·801 enrolled

Non-steroidal Anti-inflammatory Drugs1 trial

Non-steroidal Anti-inflammatory Drugs in Pleurodesis

Recruiting·—·Phase 2·NCT06731647·358 enrolled

Oral1 trial

Bioequivalence of Ketoprofen Oral Gel vs Ketoprofen Lysine Salt as Granules for Oral Solution

Completed·AAziende Chimiche Riunite Angelini Francesco S.p.A·Phase 1·NCT04678076·36 enrolled

Regulatory

FDA Approval Timeline[4]

Jul 31, 1987

ORUDIS

NDA NDA018754

Feb 8, 1995

ORUVAIL

NDA NDA019816

Oct 6, 1995

ACTRON

NDA NDA020499

Oct 6, 1995

ORUDIS KT

NDA NDA020429

Nov 25, 2009

NEXCEDE

NDA NDA022470

Sources

References

[1]
ClinicalTrials.gov — 44 trial records for Ketoprofen. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Ketoprofen compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Ketoprofen. EMBL-EBI & Wellcome Sanger Institute.
[4]
OpenFDA — FDA approval records (NDA NDA022470). U.S. Food & Drug Administration.
[5]
SEC EDGAR — Wyeth-Lederle Vaccines company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: Cyclooxygenase Inhibitor[2]
Modality: Small molecule[2]
Highest Phase: Approved[1]
Company: WWyeth-Lederle Vaccines

Oruvail

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q3 2027

Q4 2028

Q1 2033

Trials by Indication[1]

Osteoarthritis3 trials

Lymphedema3 trials

Sprain3 trials

Migraine3 trials

Treatment2 trials

Low back pain2 trials

Efficacy2 trials

Cesarean Section2 trials

Efficacy and Safety2 trials

Renal Colic2 trials

Postoperative Analgesia1 trial

Trauma1 trial

Muscle Pain1 trial

Tonsillitis1 trial

Sciatica1 trial

Perioperative Pain1 trial

Abortion1 trial

Cardiac Surgery1 trial

Third Molar1 trial

Fibrosis1 trial

Post Operative Pain1 trial

Multimodal Analgesia1 trial

Multiple Sclerosis1 trial

Sternotomy1 trial

Cesarean Delivery1 trial

Brachytherapy1 trial

Pain Management1 trial

Sore Throat1 trial

Non-steroidal Anti-inflammatory Drugs1 trial

Oral1 trial

FDA Approval Timeline[4]

References

Drug Info

Quick Facts

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