Robenacoxib
| 證據等級: L5 | 預測適應症: 10 個 |
目錄
Robenacoxib: From Veterinary Osteoarthritis to Human Osteoarthritis
One-Sentence Summary
Robenacoxib is a highly COX-2-selective NSAID currently approved only for veterinary use (dogs and cats, marketed as Onsior) for pain and inflammation, including osteoarthritis; it holds no human marketing authorisation in Denmark. The TxGNN model predicts activity against human Osteoarthritis (score 98.79%), but the underlying evidence base consists entirely of veterinary randomized trials and pharmacokinetic studies — no human clinical trial or human safety data currently exists for this compound.
⚠️ Critical caveat: The predicted “new indication” (osteoarthritis) is the same disease the drug already treats — but only in dogs and cats. This is a cross-species extrapolation signal, not a genuine new-indication repurposing candidate, until human data is generated.
Quick Overview
| Item | Content |
|---|---|
| Original Indication | Not available in Danish/human regulatory data. Per veterinary literature, Robenacoxib (Onsior®) is EU-approved for pain and inflammation associated with musculoskeletal disorders (incl. osteoarthritis) and peri-operative pain in dogs and cats only |
| Predicted New Indication | Osteoarthritis (human) |
| TxGNN Prediction Score | 98.79% |
| Evidence Level | L4 (veterinary RCT/mechanistic evidence only — no completed human trials; see note below) |
| Denmark Market Status | Not marketed (未上市) |
| Number of Marketing Authorisations | 0 |
| Recommended Decision | Hold |
On Evidence Level: the evidence pack’s internal scoring labels this “L2,” which reflects the strength of the veterinary trial base (multiple completed randomized veterinary trials). Applying the evidence-level rubric to the human indication under evaluation, there are zero completed human trials (confirmed 0 hits in ClinicalTrials.gov and ICTRP), so the correct classification for human decision-making is L4 (preclinical/mechanistic analog evidence), not L1/L2.
Why is This Prediction Reasonable?
Detailed DrugBank mechanism-of-action data is flagged as a gap (DG002) in this evidence pack. However, the retrieved literature (PMID 30148083) describes Robenacoxib as a coxib-class NSAID with high selectivity for cyclooxygenase-2 (COX-2) and weak, rapidly reversible COX-1 binding — the same mechanistic class as human NSAIDs used in osteoarthritis (e.g., celecoxib, etoricoxib). This selectivity profile is the pharmacological basis for its anti-inflammatory and analgesic effect in veterinary osteoarthritis.
The original and predicted indications are, in fact, the identical disease (osteoarthritis) — the “prediction” reflects that Robenacoxib already has strong, repeated evidence of efficacy against osteoarthritic pain, just in a different species. Mechanistically, COX-2-mediated prostaglandin synthesis and joint inflammation pathways are highly conserved between dogs, cats, and humans, which is why the TxGNN knowledge graph scores this pairing so highly.
That conservation does not, however, establish human efficacy or safety. Robenacoxib has never been evaluated in a human clinical trial; species differences in pharmacokinetics, protein binding, and GI/renal/hepatic tolerability for coxib-class NSAIDs are well documented and cannot be assumed to translate directly from cats and dogs to humans.
Clinical Trial Evidence
Currently no related human clinical trials registered (ClinicalTrials.gov and WHO ICTRP both returned 0 results for Robenacoxib + osteoarthritis).
Literature Evidence
| PMID | Year | Type | Journal | Key Findings |
|---|---|---|---|---|
| 22673598 | 2012 | RCT (veterinary, non-inferiority) | J Vet Med Sci | Oral robenacoxib non-inferior to carprofen for canine osteoarthritis over 28 days (n=32) |
| 26058587 | 2016 | RCT (veterinary, placebo-controlled) | J Feline Med Surg | Confirmed clinical safety of robenacoxib in feline osteoarthritis vs. placebo |
| 21480932 | 2012 | RCT (veterinary, non-inferiority) | J Vet Pharmacol Ther | Robenacoxib non-inferior to carprofen in canine osteoarthritis, multicentre trial (n=125+) |
| 33833276 | 2021 | RCT (veterinary) | Scientific Reports | Robenacoxib effective for degenerative joint disease pain in cats (n=109), blinded pilot trial |
| 23782347 | 2013 | Systematic Review | J Vet Intern Med | Systematic review of NSAID-induced adverse effects in dogs, including robenacoxib class |
| 38587872 | 2024 | Review/Consensus Guideline | J Feline Med Surg | 2024 ISFM/AAFP consensus guidelines on long-term NSAID use in cats |
| 30148083 | 2018 | Review | Vet Med (Auckland) | Overview of robenacoxib pharmacology, safety, and place in veterinary therapy |
| 23452411 | 2013 | Cohort/experimental (biomarker) | BMC Vet Res | Robenacoxib reduced synovial fluid C-reactive protein in dogs with osteoarthritis (n=34) |
| 31487772 | 2019 | Comparative clinical study (veterinary) | Veterinary Sciences | Compared UC-II collagen vs. robenacoxib for mobility impairment in canine osteoarthritis |
| 20922466 | 2010 | PK/population study | Pharm Res | Population PK of robenacoxib in blood and synovial fluid of healthy and osteoarthritic dogs |
Note: all 11 retrieved publications are veterinary studies; one additional PK study (PMID 23726662) was omitted from this table as duplicative of the PK entry above.
Denmark Market Information
Robenacoxib currently has no marketing authorisation in Denmark (0 licenses on record) and is not registered as a human medicinal product. It is marketed in the EU exclusively as a veterinary product (Onsior®) for use in dogs and cats.
Safety Considerations
Please refer to the approved Summary of Product Characteristics (SmPC) for safety information — no human key-warning, contraindication, or drug-interaction data is currently available for Robenacoxib (DG001, Blocking gap).
Additional context from veterinary literature: coxib-class NSAIDs as a group carry known risks of gastrointestinal, renal, and hepatic adverse effects (PMID 23782347, PMID 38587872), which would need to be re-established through human pharmacovigilance and trial data before any human use is considered.
Conclusion and Next Steps
Decision: Hold
Rationale: Robenacoxib is a veterinary-only NSAID with no Danish or human marketing authorisation, no human clinical trial data, and a blocking data gap on SmPC warnings/contraindications (DG001). The TxGNN signal is mechanistically plausible (COX-2 inhibition is a validated osteoarthritis pathway) but is built entirely on animal trial evidence, so it does not meet the bar for progressing toward human development at this time.
To proceed, the following is needed:
- Formal DrugBank/literature-sourced mechanism of action data (DG002)
- Danish/EU regulatory review of human SmPC warnings, contraindications, and drug interactions (DG001)
- At minimum, preclinical human-relevant toxicology and pharmacokinetic bridging data before any human trial is designed
- Confirmation of whether any human-formulation development program for Robenacoxib exists
Disclaimer
This content is for research purposes only and does not constitute medical advice. Clinical validation is required before any clinical application.