Budesonide

證據等級: L5

預測適應症: 10 個

Budesonide: From Asthma / Inflammatory Airway Disease to Atopic Eczema

One-Sentence Summary

Budesonide is a synthetic glucocorticoid widely used internationally as an inhaled or topical corticosteroid for asthma, COPD, and inflammatory bowel disease; however, it currently holds no SAHPRA registration in South Africa. The TxGNN model predicts it may be effective for Atopic Eczema, with 2 clinical trials and 20 publications currently associated with this direction — though most trials are only indirectly relevant to this specific indication.

Quick Overview

Item	Content
Original Indication	No SAHPRA registration on record; globally indicated for asthma, COPD, Crohn’s disease, and allergic rhinitis
Predicted New Indication	Atopic Eczema
TxGNN Prediction Score	99.96%
Evidence Level	L3 (Observational studies, formulation research, and preclinical data)
South Africa Market Status	Not Marketed
Number of SAHPRA Registrations	0
Recommended Decision	Hold (Research Question)

Why is This Prediction Reasonable?

Detailed mechanism of action data is not available from the current evidence pack. Based on established pharmacological knowledge, budesonide is a high-potency synthetic glucocorticoid that exerts potent local anti-inflammatory effects while having a favourable systemic safety profile due to extensive first-pass hepatic metabolism. It acts primarily by suppressing NF-κB signalling, downregulating Th2 cytokines (IL-4 and IL-13), reducing mast cell activation, and decreasing eosinophil infiltration into inflamed mucosal and cutaneous tissue.

Atopic eczema is a chronic, relapsing Th2-skewed inflammatory skin disorder characterised by skin barrier disruption, elevated IgE, and eosinophilic infiltration — all of which are direct targets of glucocorticoid therapy. Topical corticosteroids are globally recognised as first-line standard care for atopic dermatitis, and budesonide’s mechanism maps well onto the core immunopathology of this condition. The TxGNN prediction therefore aligns closely with established dermatological practice for the corticosteroid drug class as a whole.

Active research interest in budesonide specifically for atopic dermatitis is reflected in recent formulation work: a 2024 study (PMID 38275852) developed pH-sensitive Eudragit L100 polymeric nanoparticle hydrogels loaded with budesonide for local therapy of paediatric atopic dermatitis, aiming to overcome the skin barrier and reduce systemic absorption. This signals that budesonide’s anti-inflammatory profile is considered scientifically valid for this indication, with ongoing efforts to optimise its delivery.

Clinical Trial Evidence

Trial Number	Phase	Status	Enrollment	Key Findings
NCT01028560	Phase 1/2	Completed	58	Evaluated sublingual allergy immunotherapy in atopic, wheezing children aged 18 months–3 years at high risk for persistent asthma; atopic eczema was an inclusion criterion, not a primary endpoint. Budesonide was not the study intervention. Indirect relevance only.
NCT04680117	N/A	Unknown	150	Characterisation of severe paediatric asthma endotypes (ages 0–12 years) combining phenotypic, immune, metabolomic and microbial analyses; atopy and eczema features included in phenotyping, but neither budesonide nor atopic eczema treatment was the primary focus.

Note: Neither trial directly evaluates budesonide as a treatment for atopic eczema. No Phase 2 or higher RCTs specifically investigating budesonide for this indication were identified in the current evidence search.

Literature Evidence

PMID	Year	Type	Journal	Key Findings
38275852	2024	Formulation/Preclinical	Gels (Basel)	pH-sensitive Eudragit L100 nanoparticles loaded with budesonide formulated into hydrogels for topical delivery in paediatric atopic dermatitis; demonstrated improved budesonide release at acidic atopic lesion pH and potential to enhance localised therapy
8864369	1996	Cohort	Dermatology (Basel)	Insulin-like growth factor axis, bone and collagen turnover in children with atopic dermatitis receiving topical glucocorticosteroids; highlights systemic absorption risk and the need for growth monitoring in paediatric topical use
19875223	2010	Clinical Observation	Allergologia et Immunopathologia	Compared budesonide response in atopic vs. non-atopic infants and preschoolers with recurrent wheezing; demonstrates budesonide efficacy within the broader atopic disease spectrum
35133669	2022	Cross-sectional	Contact Dermatitis	Pattern of contact sensitisation in atopic dermatitis patients at an Asian dermatology centre; budesonide among corticosteroids assessed for sensitisation risk, documenting similar or higher sensitisation rates in AD patients
30053491	2018	Retrospective	J Am Acad Dermatol	Allergic contact dermatitis to personal care products and topical medications in adults with AD; skin barrier disruption and immune dysregulation in AD predispose to sensitisation to topical corticosteroids including budesonide
24603519	2014	Cross-sectional	Dermatitis	Contact hypersensitivity to European standard series and corticosteroid patch test series — including budesonide — in adolescents and adults with atopic dermatitis; relevant to safety monitoring
33931866	2021	Observational	Contact Dermatitis	Budesonide patch testing in Italy using the SIDAPA baseline series (2018–2019); decreasing trend of budesonide allergy over two decades provides reassurance regarding sensitisation risk in topical use
40020933	2025	Translational	J Allergy Clin Immunol	Cutaneous ceramide synthesis dysregulation in paediatric eosinophilic esophagitis parallels atopic dermatitis epithelial barrier dysfunction; supports shared inflammatory pathways relevant to corticosteroid responsiveness across atopic conditions
14616123	2003	Review	Allergy	Corticosteroid allergy in asthma patients; delayed contact allergy to budesonide documented as a class effect; clinically relevant safety consideration for topical use in atopic dermatitis
19571596	2009	Review	Neuroimmunomodulation	Intranasal corticosteroids and adrenal suppression; allergic rhinitis frequently co-exists with atopic dermatitis in the atopic march; HPA axis monitoring strategies reviewed for multi-route corticosteroid exposure

South Africa Market Information

Budesonide is not currently registered with the South African Health Products Regulatory Authority (SAHPRA) and is not marketed in South Africa. No product licences are on record.

Any clinical use of budesonide in South Africa would require a Section 21 (unregistered medicines) authorisation from SAHPRA, or access through a registered clinical trial. Healthcare professionals requiring this medicine should consult SAHPRA’s regulatory guidance for accessing unregistered products.

Safety Considerations

As budesonide has no current SAHPRA registration, there is no locally approved Professional Information (PI) available. Prescribers should consult internationally recognised references (e.g., the EMA-approved Summary of Product Characteristics or US FDA Prescribing Information). Report any adverse drug reactions to SAHPRA via the MedSafety reporting system.

The following safety signals are relevant to topical/dermatological use based on the available evidence:

HPA Axis Suppression: Risk of hypothalamic-pituitary-adrenal axis suppression with prolonged topical use over large body surface areas, particularly in infants and young children (supported by PMID 8864369 and PMID 19571596)
Growth Suppression in Children: Topical corticosteroids may suppress short-term growth velocity in paediatric patients; knemometry monitoring has been studied in this context
Corticosteroid Contact Sensitisation: Budesonide is included in the European Baseline Patch Test Series as a corticosteroid hypersensitivity marker; sensitisation rates in atopic dermatitis patients may be elevated compared to the general population (PMID 35133669, PMID 24603519, PMID 33931866)
Local Skin Effects: Risk of skin atrophy, striae, and telangiectasia with prolonged use on sensitive skin areas

Conclusion and Next Steps

Decision: Hold (Research Question)

Rationale: Although topical glucocorticoids are internationally recognised as first-line therapy for atopic dermatitis and the mechanistic rationale for budesonide is strong, the current evidence base contains no direct Phase 2+ RCTs evaluating budesonide specifically for atopic eczema. Available literature is predominantly observational, cross-sectional, and formulation/preclinical in nature (L3). Furthermore, budesonide has no SAHPRA registration in South Africa, which represents an additional regulatory barrier to immediate clinical application.

To proceed, the following is needed:

Regulatory pathway: Explore SAHPRA Section 21 authorisation or registration pathway for topical budesonide formulations indicated for atopic dermatitis
Mechanism of action documentation: Retrieve complete MOA data from DrugBank (DB01222) to strengthen the mechanistic justification (addresses Data Gap DG002)
Clinical trial evidence: Identify or commission Phase 2/3 RCTs directly evaluating budesonide (conventional topical or novel nanoparticle formulations) for atopic eczema in human subjects
Novel delivery evaluation: Assess the clinical translation potential of budesonide nanoparticle hydrogels (as described in PMID 38275852) for improved efficacy and reduced systemic absorption in atopic dermatitis
Safety profile for topical use: Conduct a systematic assessment of HPA axis suppression risk, growth monitoring requirements, and sensitisation rates specifically for the topical dermatological route and paediatric populations in a South African context
SAHPRA PI development: If pursuing registration, prepare full prescribing information and safety warnings per SAHPRA requirements

This report is generated for research purposes only and does not constitute medical advice. Predicted repurposing candidates require clinical validation before any therapeutic application. All website content is subject to YMYL disclaimers.

Disclaimer

This content is for research purposes only and does not constitute medical advice. Clinical validation is required before any clinical application.