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ketoprofen (Menamin SR / ketoprofen, Biovail / Oruvail)

✓ Approved

Roche · PTGS1 · Small Molecule

What is ketoprofen?

ketoprofen is a small molecule developed by Roche. It is approved for therapeutic indications via oral (po).

Drug Profile

Brand NamesMenamin SR, ketoprofen, Biovail, Oruvail
CompanyRoche
Drug ClassSmall Molecule
Molecular TargetPTGS1, PTGS2
RouteOral (PO)
StatusApproved
Sources: ClinicalTrials.gov, Roche

Mechanism of Action

Molecular Targets

ketoprofen acts on 2 molecular targets:

PTGS1prostaglandin-endoperoxide synthase 1 (COX3, PCOX1)
PTGS2prostaglandin-endoperoxide synthase 2 (GRIPGHS, hCox-2)
Want deeper analysis?Noah AI can explain complex mechanisms and compare to similar drugs.

Therapeutic Indications

ketoprofen is developed for 2 unique indications across 2 therapeutic areas.

Therapeutic AreaConditionPhase
Gastrointestinal disordersAbdominal pain✓ Approved
Hepatobiliary disordersHepatitis✓ Approved

Related Research Articles

PubMedLymphology2026-11-09

Pharmacological Treatment of Lymphedema:State of The Art.

Chatzelas D A DA, Kantzas M I MI, Dimakakos E P EP

Lymphedema is a chronic, progressive disorder characterized by impaired lymphatic transport, persistent inflammation, adipose deposition, and tissue fibrosis. Although complete decongestive therapy remains the cornerstone of management, it does not directly modify the biological mechanisms responsible for disease progression. This review summarizes current evidence on the pharmacological treatment of primary and secondary lymphedema. A comprehensive literature search of MEDLINE/PubMed, Scopus, Web of Science, and the Cochrane Library was performed from database inception to June 30, 2026, supplemented by manual reference screening. Experimental studies, clinical trials, observational studies, systematic reviews, and consensus documents evaluating pharmacological, biological, gene-based, and regenerative therapies were included. Conventional agents, including diuretics, benzopyrones, flavonoid-derived veno-active drugs, selenium, and doxycycline, have demonstrated limited or inconsistent clinical benefit. More recently, advances in lymphatic biology have identified promising therapeutic targets, including ketoprofen, selective leukotriene B4 inhibition, topical tacrolimus, interleukin-4/interleukin-13 blockade, trans-forming growth factor-β inhibition, glucagon-like peptide-1 receptor agonists, vascular en-dothelial growth factor-C gene therapy, and cell-based regenerative approaches. Future progress will depend on adequately powered, phenotype-specific clinical trials integrating emerging pharmacological therapies with established conservative and surgical man-agement.

PMID 43003070
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PubMedInternational journal of pharmaceutical compounding2026-10-31

Topical Ketoprofen 5%, Amitriptyline HCL 5%, and Lidocaine 5% Compounded in VersaPro Cream for Diabetic Peripheral Neuropathy: A Case Report.

McSwan Joyce J, Haiub Halema H

Peripheral neuropathy is a common complication of type 1 and type 2 diabetes, often resulting in severe pain that significantly impacts the quality of life. This case report describes the treatment of a 56-year-old female patient with severe peripheral neuropathic pain in the lower extremities due to type 1 diabetes after pain persisted while using conventional therapy. The patient was prescribed a compounded topical cream containing Ketoprofen 5%, Amitriptyline HCL 5%, and Lidocaine 5% in VersaPro Cream Base to help address symptoms of diabetic peripheral neuropathy in addition to her systemic medications. Over an 8-week treatment period, the patient reported significant reductions in pain intensity and improved functional outcomes, including sleep quality and mobility. This case highlights the potential benefit of compounded topical analgesics as an adjunct therapy for managing neuropathic pain in patients with limited treatment options, and when conventional options may not be suitable.

PMID 42965422
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PubMedFrontiers in pain research (Lausanne, Switzerland)2026-10-31

Use of NSAIDs in orthopedic pain management: a Delphi consensus promoted by the Italian Society of Orthopedics and Traumatology (SIOT).

Tranquilli Leali Paolo P, Di Martino Alberto A, Mercurio Michele M, Spinelli Maria Silvia MS et al.

Non-steroidal anti-inflammatory drugs (NSAIDs) are a cornerstone of pain management in orthopedics, yet significant variability persists in prescribing practices and adherence to guidelines. A two-round modified Delphi consensus was conducted under the coordination of a methodologist, involving a scientific board of seven members and a broader expert panel of orthopedic surgeons, anesthesiologists, and pharmacologists affiliated with the Italian Society of Orthopedics and Traumatology (SIOT). Twenty statements spanning four domains-NSAID mechanisms of action, perioperative pain management in elective surgery, traumatic pain, and non-oncological/oncological pain-were submitted for evaluation using a six-point Likert scale; consensus was defined as ≥75% of ratings concentrating within a single tertile. Of the 20 statements, 12 reached consensus in the first round; six revised statements reached consensus in the second round; and two were eliminated because of persistent opinion dispersion. Final recommendations endorse short-cycle NSAID therapy (7-10 days) within multimodal analgesia, support the use of symptomatic slow-acting drugs for osteoarthritis to reduce NSAID consumption in osteoarthritis, recommend NSAIDs perioperatively in frail fracture patients to limit opioid use and delirium, identify ketoprofen lysine salt as having a favorable risk-benefit profile for postdischarge pain, and emphasize individualized NSAID selection based on cardiovascular, renal, and antiplatelet risk factors. This SIOT consensus provides evidence-informed, clinically actionable recommendations for NSAID use across the principal orthopedic pain scenarios, aiming to improve prescribing appropriateness and patient safety in routine practice.

PMID 42964588
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PubMedCureus2026-10-30

Impact of Morphine on Early Recovery After Anterior Cruciate Ligament Reconstruction: A Case-Control Study.

Moussa Mohamad K MK, Mrabet Fethi F, Valentin Eugénie E, Grimaud Olivier O et al.

Effective pain management is crucial in postoperative recovery after Anterior Cruciate Ligament Reconstruction (ACLR). To examine the effectiveness of the new opioid-containing protocol compared to another previously published protocol based on Nefopam and dynamic compression cryotherapy. This retrospective analysis of prospectively collected data was conducted at a sports surgery center between 2023 and 2024, including 1116 patients undergoing primary isolated ACLR. Patients were divided into two matched groups based on postoperative pain management: the opioid group (N=556), treated with oral morphine sulfate (Actiskenan®) as needed in addition to multimodal analgesia (e.g., paracetamol, nefopam, and ketoprofen), and the non-opioid group N=556, treated with multimodal analgesia alone. Patients were matched for age, sex, BMI, Lysholm score, Tegner score, meniscal injury, and chondropathy. The primary outcome was pain on the visual analogue scale (VAS) in the early postoperative period, analyzed in relation to the minimal clinically important difference (MCID) and the patient acceptable symptom state (PASS) thresholds for VAS. The secondary outcome was side effects, including nausea, dizziness, vomiting, anxiety, and abdominal pain, as well as early complications and revision rate. The mean age in both groups was comparable (32.2 ± 9.4 years in the non-opioid group [N = 556] and 32.5 ± 10.0 years in the opioid group [N = 556], p = 0.867). Both groups predominantly used the quadrupled hamstring graft technique (440/556, 80.0% vs. 438/556, 79.9%, p = 0.4455). Preoperative scores were similar (p > 0.05). Postoperative pain was higher in the non-opioid group: day 0 VAS scores were 5.6 ± 2.7 (n = 536/556) vs. 5.3 ± 2.7 (n = 522/556) (p = 0.0339), and night pain was more common (379/556, 68.2% vs. 341/556, 61.3%, p = 0.0202). This trend continued on day 1 (5.2 ± 2.4 [n = 545/556] vs. 4.8 ± 2.4 [n = 543/556], p = 0.0014), day 2 (4.5 ± 2.4 [n = 551/556] vs. 4.2 ± 2.3 [n = 550/556], p = 0.0182), and day 3 (3.8 ± 2.3 [n = 551/556] vs. 3.4 ± 2.2 [n = 551/556], p = 0.0080). The non-opioid group had higher rates of dizziness on day 0 (100/536, 18.7% vs. 70/522, 13.4%, p = 0.0236). There was a trend toward higher complications in the non-opioid group (11/556, 2.0% vs. 3/556, 0.5%, p = 0.0558), mainly due to Cyclops syndrome and knee stiffness. Reoperation rates were similar (p > 0.05). Adding morphine to the postoperative protocol was associated with reduced postoperative pain in the first 3 days postoperatively and dizziness on the first day. However, while statistically significant, the mean difference in VAS scores did not exceed the MCID.

PMID 42959591
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PubMedEuropean journal of pharmaceutics and biopharmaceutics : official journal of Arbeitsgemeinschaft fur Pharmazeutische Verfahrenstechnik e.V2026-10-29

Impact of phosphate buffer strength and unbuffered water on ionizable drug powder dissolution.

Patel Roshni P RP, Polli James E JE

We are unaware of prior reports of the dependence of drug powder dissolution on buffer strength. The objective was to assess the effect of 5, 10, 50, and 100 mM sodium phosphate concentration on in vitro particle dissolution of ionizable drugs. Three weakly acidic drugs (naproxen, piroxicam, and phenytoin) and one weakly basic drug (dipyridamole) were studied at different pH conditions. Dissolution was conducted using USP Apparatus II with a mini-paddle at 37 °C in 100 mL media. Overall, the effect on dissolution profile was modest, with the largest effect generally being between 5 mM phosphate and zero phosphate (i.e., unbuffered water). Hence, a secondary objective was to predict the dissolution of the four ionizable drugs into unbuffered water, as well as for ibuprofen, ketoprofen, indomethacin, haloperidol, and meloxicam. Predictions anticipated slower ionizable drug dissolution into unbuffered water. Overall, dissolution predictions into buffer were better using the transient pH film model that accounts for the changing solid-liquid interfacial pH during dissolution, than for the conventional z-factor film model.

PMID 42957101
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PubMedPharmaceutics2026-10-27

Understanding the Role of Solvents in Hypromellose-Based Film-Forming Solutions for Topical Administration of Ketoprofen Through a Design of Experiments Approach.

Milinković Sandra S, Kurćubić Ivana I, Đuriš Jelena J, Đekić Ljiljana L

Background/Objectives: Topical ketoprofen gels are limited by the need for frequent reapplication, short skin residence time, and the risk of sunlight-induced photoallergic dermatitis. Film-forming solutions (FFSs) allow for extended retention; however, the solvents used may affect the polymer film's characteristics. The present study aimed to elucidate the effect of macrogol 400 and isopropanol and develop a hypromellose-based ketoprofen FFS using a design of experiments (DoE) approach. Methods: A 32 full factorial design was applied to investigate the effects of macrogol 400 (0-5%, w/w) (X1) and isopropanol (25-50%, w/w) concentrations (X2) on film mechanical properties (tensile strength (Y1), elongation at break (Y2), and Young's modulus (Y3)). The DoE-based placebo and ketoprofen-loaded FFSs were characterized for their physicochemical, rheological, and textural properties, while the corresponding films were evaluated for appearance, weight, stickiness, and mechanical properties. In vitro ketoprofen release from the drug-loaded FFS was also evaluated. Results: Macrogol 400 concentration was identified as a significant factor influencing film mechanical properties. As a film plasticizer, macrogol 400 improved film mechanical properties up to the optimal concentration (2.75%), whereas the water/isopropanol ratio mainly affected the applicative (rheological and textural) properties of the FFSs. Ketoprofen incorporation significantly reduced the film tensile strength and elongation at break. In vitro release testing demonstrated 58.52% ketoprofen release after 6 h, with the Weibull model showing the best fit to the release profile. Conclusions: Macrogol 400 and isopropanol have a complex, mutually conditioned influence on the application characteristics of hypromellose-based FFS and the mechanical characteristics of the films. Incorporation of ketoprofen into the selected placebo formulation significantly reduced film deformability but yielded a thin, transparent film with favorable in vitro drug-release characteristics. The developed FFS represents a promising topical dosage form for non-steroidal anti-inflammatory drugs and warrants further investigation, particularly in terms of skin retention and in vivo performance.

PMID 42942781
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