Budesonide
| Evidence Level: L4 | Predicted Indications: 10 |
Table of Contents
Budesonide: From Crohn's Disease and Asthma to Atopic Eczema
One-Sentence Summary
Budesonide is a glucocorticoid originally used for inflammatory bowel conditions (Crohn's disease), airway diseases (asthma) and allergic or vasomotor rhinitis. The TxGNN model predicts it may be effective for atopic eczema, but there are no registered clinical trials and the retrieved publications are mostly indirect (contact allergy, adrenal suppression, and one preclinical formulation study). Of all the predictions, bronchitis has the strongest supporting evidence (10 related trials and 20 publications), so it is also discussed below as a comparison.
Quick Overview
| Item | Content |
|---|---|
| Original Indication | Crohn's disease, inflammatory bowel disease, asthma, allergic rhinitis and related conditions (the Singapore licence records contain no approved-indication text) |
| Predicted New Indication | Atopic eczema |
| TxGNN Prediction Score | 99.96% |
| Evidence Level | L4 |
| Singapore Market Status | ✓ Marketed |
| Number of Registrations | 15 |
| Recommended Decision | Hold |
Why is This Prediction Reasonable?
Detailed mechanism-of-action data is not available in the data compiled for this report. Based on known pharmacology, budesonide is a glucocorticoid that acts through the glucocorticoid receptor. It has broad anti-inflammatory and immunosuppressive effects, and it suppresses pro-inflammatory cytokines and the recruitment of immune cells into inflamed tissue.
Its established uses (asthma, allergic rhinitis, Crohn's disease) are all driven by mucosal or allergic inflammation. Atopic eczema is a type 2 inflammatory skin disease, so a corticosteroid mechanism is biologically plausible. Topical corticosteroids are already a standard therapy class for atopic dermatitis.
However, the evidence for budesonide itself in atopic eczema is weak. The only directly relevant item is a preclinical study of budesonide nanoparticle hydrogels for local atopic dermatitis therapy. Much of the other literature concerns contact allergy to corticosteroids (budesonide is a known marker for corticosteroid hypersensitivity in patch testing), which is a safety concern rather than support for efficacy. The prediction is a reasonable hypothesis at this stage, not a validated finding.
Clinical Trial Evidence
Currently no related clinical trials registered for atopic eczema.
For comparison, the second-ranked prediction, bronchitis (score 99.81%, evidence level L2), has the following trials. The most relevant ones are listed. All are small or only indirectly matched, and none is a Phase 3 RCT in bronchitis proper.
| Trial Number | Phase | Status | Enrollment | Key Findings |
|---|---|---|---|---|
| NCT02002715 | Phase 4 | Completed | 106 | Different inhaled corticosteroid treatment durations in eosinophilic bronchitis |
| NCT06571942 | Phase 4 | Unknown | 128 | Inhaled triple therapies on small airways in COPD or chronic bronchitis without obstruction (budesonide is part of a combination) |
| NCT00483743 | Phase 2 | Completed | 62 | Randomised, double-blind, placebo- and active-controlled 6-week study of inhaled TPI 1020 versus budesonide in COPD |
| NCT00624754 | Phase 2 | Completed | 32 | Budesonide/formoterol in bronchiolitis obliterans after stem cell transplant |
| NCT01560689 | Phase 2 | Completed | 32 | Open-label budesonide/formoterol in bronchiolitis obliterans after stem cell transplant |
| NCT00202189 | Phase 4 | Completed | 4 | Acute effects of inhaled corticosteroids on airway function in COPD (too small to show efficacy) |
Literature Evidence
Publications most relevant to atopic eczema / atopic dermatitis:
| PMID | Year | Type | Journal | Key Findings |
|---|---|---|---|---|
| 38275852 | 2024 | Preclinical formulation study | Gels | Budesonide-loaded pH-sensitive nanoparticles in hydrogels for local atopic dermatitis therapy |
| 21062310 | 2010 | Randomised, placebo-controlled trial (dogs) | J Vet Pharmacol Ther | 0.025% budesonide leave-on conditioner reduced skin lesions and pruritus in dogs with atopic dermatitis (veterinary) |
| 9496795 | 1998 | Open longitudinal study | Pediatr Dermatol | Knemometry in 14 children with atopic dermatitis to assess short-term growth effects of topical budesonide |
| 8864369 | 1996 | Clinical study | Dermatology | Growth factor, bone and collagen turnover in children with atopic dermatitis on topical corticosteroids |
| 16428071 | 2006 | Laboratory study | Int Immunopharmacol | Budesonide affects immune functions of normal human keratinocytes, unlike tacrolimus |
| 33931866 | 2021 | Patch-test study | Contact Dermatitis | Budesonide is a marker of corticosteroid hypersensitivity; allergy rates have declined over two decades |
| 14616123 | 2003 | Review | Allergy | Corticosteroid allergy occurs in patients with asthma and those using inhaled corticosteroids |
| 19571596 | 2009 | Review | Neuroimmunomodulation | Intranasal corticosteroids and adrenal suppression in allergic disease |
| 37927648 | 2023 | Case report | Cureus | Steroid-induced angioedema and urticaria in a patient with atopic dermatitis history |
None of these is a human efficacy trial of budesonide in atopic eczema.
Singapore Market Information
Budesonide has 15 valid single-ingredient registrations, with no cancelled ones. The licence records contain no approved-indication text. The five main authorisations are:
| Authorization Number | Product Name | Dosage Form | Approved Indication |
|---|---|---|---|
| SIN16972P | NEFEGAN Modified Release Capsule 4 mg | Capsule | Not specified in the records |
| SIN11588P | BUDENOFALK Capsule 3 mg | Capsule | Not specified in the records |
| SIN14115P | Budenofalk Rectal Foam 2 mg/dose | Aerosol, foam | Not specified in the records |
| SIN05043P | PULMICORT Turbuhaler 100 mcg/dose | Metered powder | Not specified in the records |
| SIN14029P | Budesonide Nasal Spray Suspension 64 mcg | Suspension spray | Not specified in the records |
The other licences cover further inhaled, nasal-spray and combination products (for example Giona Easyhaler, Symbicort Turbuhaler, Duoresp Spiromax, Breztri Aerosphere, Budiair and Esonide). No topical skin formulation is registered, so any atopic eczema use would require a new dermal formulation or an off-label approach.
Safety Considerations
- Contraindication-related conditions (from the knowledge graph, not label text): Associations are listed with conditions including hypertension, congestive heart failure, epilepsy, liver disease, gallbladder disease, hyperglycaemia, herpes simplex keratitis, measles, hypopituitarism and growth hormone deficiency, and several urea-cycle disorders. Please verify against the product label.
- Drug interactions: 100 interactions were found. Those graded Major include adalimumab and fosamprenavir. Many are Moderate, for example zidovudine, ketorolac, ibuprofen, nifedipine, ethinylestradiol, fluvoxamine and fosaprepitant. Formoterol and salbutamol are Minor.
- Literature-derived concerns: Corticosteroid contact allergy (budesonide is a patch-test marker), adrenal suppression with intranasal use, and possible effects on growth in children with topical use.
Please refer to the package insert for the official warnings and contraindications, as these were not available in the data compiled for this report.
Conclusion and Next Steps
Decision: Hold
Rationale: The TxGNN score for atopic eczema is very high (99.96%), and the glucocorticoid mechanism is plausible. However, there are no registered trials, no budesonide-specific human efficacy data, and no registered topical skin product in Singapore. Evidence is at the preclinical level (L4). By contrast, bronchitis (L2) has more supporting data and is a better candidate for follow-up. The remaining predictions (polyps of the vocal cord, middle ear, external auditory canal and uterus, fibroepithelial polyp, epulis) have prediction-only evidence (L5). The frontal sinus polyp prediction has indirect supportive literature (L4).
To proceed, the following is needed:
- Package insert warnings and contraindications from the Health Sciences Authority (HSA).
- Mechanism-of-action data from DrugBank.
- Human clinical data on budesonide in atopic eczema (for example a Phase 2 trial with a dermal formulation).
- Assessment of a suitable topical formulation and its skin-sensitisation risk, including contact allergy and growth or adrenal effects in children.
- Comparison with existing topical corticosteroids and other approved atopic dermatitis therapies.
Disclaimer
This content is for research purposes only and does not constitute medical advice. Clinical validation is required before any clinical application.