Aceclofenac
| Evidence Level: L5 | Predicted Indications: 10 |
Table of Contents
- Aceclofenac
- Aceclofenac: From Rheumatic and Osteoarticular Conditions to Brachyolmia-Amelogenesis Imperfecta Syndrome
Aceclofenac: From Rheumatic and Osteoarticular Conditions to Brachyolmia-Amelogenesis Imperfecta Syndrome
One-Sentence Summary
Aceclofenac is an oral NSAID originally used for pain and inflammation in rheumatoid arthritis, ankylosing spondylitis and osteoarthritis. The TxGNN model's top-ranked prediction is brachyolmia-amelogenesis imperfecta syndrome, a rare genetic skeletal and dental disorder, but no clinical trials and no publications support it. The only prediction in the top 10 with meaningful literature is inflammatory spondylopathy (rank 8), and that is largely a re-labeling of an existing indication.
Quick Overview
| Item | Content |
|---|---|
| Original Indication | Rheumatoid arthritis, ankylosing spondylitis, osteoarthritis, arthropathy, frozen shoulder (from the knowledge graph; the Singapore licence has no indication text on file) |
| Predicted New Indication | Brachyolmia-amelogenesis imperfecta syndrome (rank 1) |
| TxGNN Prediction Score | 99.89% |
| Evidence Level | L5 |
| Singapore Market Status | ✓ Marketed |
| Number of Registrations | 1 |
| Recommended Decision | Hold |
Why is This Prediction Reasonable?
Detailed mechanism of action data is not available. Based on known information, aceclofenac is a COX-2-preferential NSAID that inhibits prostaglandin synthesis and relieves inflammatory pain. Its efficacy in rheumatoid arthritis, ankylosing spondylitis and osteoarthritis is well documented.
For the top-ranked prediction, no mechanistic link could be identified. Brachyolmia-amelogenesis imperfecta syndrome is a heritable skeletal and dental disorder. A symptomatic anti-inflammatory drug would not be expected to modify its underlying genetic pathology. The high score is a model output only.
The same holds for the other highly ranked skeletal dysplasias: acromesomelic dysplasia (Hunter-Thompson type), brachyolmia and pseudoachondroplasia. At most, NSAIDs could offer symptomatic pain relief in these conditions.
A few lower-ranked predictions have some indirect plausibility:
- Inflammatory spondylopathy (rank 8): Aceclofenac is already used in ankylosing spondylitis, so this is mostly a re-labeling of an existing indication and not true repurposing.
- Myosclerosis and hypermobility of coccyx (ranks 3 and 6): NSAIDs are commonly used for musculoskeletal pain, but there is no aceclofenac-specific evidence.
- Rheumatoid vasculitis and polyarticular juvenile rheumatoid arthritis (ranks 7 and 9): These are adjacent to the approved rheumatoid arthritis use. Rheumatoid vasculitis needs immunosuppression, and no paediatric data or dosing are available.
- Kummell disease (rank 10): Symptomatic pain relief is the most that could be expected.
Clinical Trial Evidence
Currently no related clinical trials registered for any of the top 10 predicted indications.
Literature Evidence
There is no literature for the top-ranked indication (brachyolmia-amelogenesis imperfecta syndrome). The literature below relates to inflammatory spondylopathy (rank 8), the only prediction with publications. It is dominated by ankylosing spondylitis, which is already an original indication. The data compiled for this report returned only part of the full record list, and abstracts and study designs were not fully reviewed.
| PMID | Year | Type | Journal | Key Findings |
|---|---|---|---|---|
| 8823693 | 1996 | Controlled clinical trial | J Rheumatol | Efficacy and tolerability of aceclofenac vs indomethacin in active ankylosing spondylitis (multicentre) |
| 8823692 | 1996 | Comparative trial (double-blind) | J Rheumatol | Aceclofenac 100 mg twice daily was as safe and effective as tenoxicam over 3 months in ankylosing spondylitis |
| 34876850 | 2021 | Review | J Pain Res | Analgesic and anti-inflammatory effects of aceclofenac in musculoskeletal disorders, including low back pain, osteoarthritis, rheumatoid arthritis and ankylosing spondylitis |
| 15163279 | 2004 | Review | Expert Opin Pharmacother | Aceclofenac was as effective as diclofenac, naproxen and piroxicam in osteoarthritis, and as effective as comparators in rheumatoid arthritis and ankylosing spondylitis |
| 11511027 | 2001 | Review | Drugs | Symptomatic relief in painful rheumatic conditions, with efficacy similar to diclofenac, piroxicam and naproxen in knee osteoarthritis |
| 8799688 | 1996 | Review | Drugs | Pharmacology and therapeutic potential; efficacy at least equivalent to ketoprofen and similar to indomethacin and diclofenac in rheumatoid arthritis |
| 11523298 | 2001 | Review | Rev Med Liege | Role in chronic osteoarthritis, including effects on inflammatory mediators and cartilage remodeling |
| 10081315 | 1999 | Drug profile | Rev Med Liege | Overview of indications and usual dosage (100 mg twice daily) |
| 16922973 | 2006 | Case report | J Eur Acad Dermatol Venereol | Generalized pustular psoriasis precipitated by aceclofenac (a safety signal) |
| 22350497 | 2012 | Review | Clin Drug Investig | NSAID gastroprotection with proton pump inhibitors in rheumatic disorders |
Singapore Market Information
| Authorization Number | Product Name | Dosage Form | Approved Indication |
|---|---|---|---|
| SIN15700P | AIRTAL FILM COATED TABLETS 100mg | Tablet, film coated (oral) | Not specified in the registration data |
Safety Considerations
Please refer to the package insert for safety information.
One published case report describes generalized pustular psoriasis precipitated by aceclofenac. No drug interaction records were found.
Conclusion and Next Steps
Decision: Hold
Rationale: The top-ranked predictions are rare genetic skeletal or dental disorders with no clinical trials, no literature and no plausible disease-modifying mechanism for a symptomatic NSAID. The only prediction with literature (inflammatory spondylopathy) overlaps with an existing indication and does not represent new repurposing.
To proceed, the following is needed:
- Mechanism of action data for aceclofenac (DrugBank)
- Package insert warnings and contraindications from HSA, which are required before any safety screening
- Singapore approved-indication text for the registered product
- Full review of the literature for inflammatory spondylopathy, if that indication is pursued
- Paediatric safety and dosing data before considering polyarticular juvenile rheumatoid arthritis
- A clear rationale for symptomatic-only use (for example, pain management) if any skeletal dysplasia is considered
Disclaimer
This content is for research purposes only and does not constitute medical advice. Clinical validation is required before any clinical application.