Budesonide
| Evidence Level: L5 | Predicted Indications: 10 |
Table of Contents
Budesonide: From Marketed Corticosteroid Products to Atopic Eczema
One-Sentence Summary
Budesonide is a glucocorticoid marketed in South Africa in capsule, inhaler, nebule and nasal-spray forms. The SAHPRA indication text was not available in the source data. The TxGNN model predicts it may be effective for atopic eczema. Only 2 registered clinical trials and 20 publications were retrieved, and none is a human efficacy study of budesonide in eczema.
Quick Overview
| Item | Content |
|---|---|
| Predicted New Indication | Atopic eczema |
| TxGNN Prediction Score | 99.96% |
| Evidence Level | L4 (preclinical/mechanism only) |
| South Africa Market Status | Marketed |
| Number of SAHPRA Registrations | 5 |
| Recommended Decision | Hold |
Why is This Prediction Reasonable?
Budesonide is a glucocorticoid receptor agonist with broad anti-inflammatory activity. Detailed mechanism data are not available from DrugBank in this pack, so this description comes from the repurposing rationale.
Topical corticosteroids as a class are an established treatment for atopic dermatitis, so the mechanistic link is plausible. Budesonide has also been used topically in children with atopic dermatitis in small studies, and a 2024 preclinical study developed a budesonide hydrogel for this purpose.
The support is therefore class-effect reasoning plus formulation research. There are no budesonide-specific human trials for eczema. The SAHPRA-registered forms are oral, inhaled and nebulised, not dermal, so the route needed for eczema is not currently registered.
Note that “dermatitis, atopic” (rank 3) is a duplicate of this concept and should be merged with it.
Clinical Trial Evidence
| Trial Number | Phase | Status | Enrollment | Key Findings |
|---|---|---|---|---|
| NCT01028560 | Phase 1/2 | Completed | 58 | Allergy immunotherapy to prevent asthma in atopic wheezing children. Not a budesonide trial, and the endpoint is asthma, not eczema. |
| NCT04680117 | N/A | Unknown | 150 | Non-interventional endotyping of severe paediatric asthma. Does not test budesonide for eczema. |
Neither trial is relevant to budesonide treatment of eczema. No SANCTR or PACTR identifiers were found.
Literature Evidence
Only 10 of the 20 retrieved publications are listed below.
| PMID | Year | Type | Journal | Key Findings |
|---|---|---|---|---|
| 21062310 | 2010 | Randomised placebo-controlled crossover trial (dogs) | J Vet Pharmacol Ther | 0.025% budesonide leave-on conditioner reduced skin lesions and pruritus in canine atopic dermatitis. Veterinary evidence only. |
| 9496795 | 1998 | Open longitudinal trial | Pediatr Dermatol | Short-term growth (knemometry) assessed in 14 children with atopic dermatitis treated with topical budesonide. This is a safety study, not an efficacy study. |
| 38275852 | 2024 | Preclinical formulation study | Gels (Basel) | Budesonide-loaded pH-sensitive nanoparticles in hydrogels for local atopic dermatitis therapy. |
| 8864369 | 1996 | Clinical study | Dermatology | Bone and collagen turnover and the IGF axis in children with atopic dermatitis on topical glucocorticoids. Drug identity unconfirmed. |
| 14616123 | 2003 | Review | Allergy | Corticosteroid allergy in asthma. Glucocorticoids frequently cause delayed contact allergy. |
| 33931866 | 2021 | Patch-test series | Contact Dermatitis | Budesonide patch testing in Italy. A decreasing trend of budesonide allergy has been observed. |
| 35133669 | 2022 | Cohort | Contact Dermatitis | Contact sensitisation patterns in patients with and without atopic dermatitis. |
| 24603519 | 2014 | Cohort | Dermatitis | Contact hypersensitivity, including corticosteroid series, in patients with atopic dermatitis. |
| 35184304 | 2022 | Case report | Contact Dermatitis | Systemic allergic dermatitis after budesonide patch testing. |
| 37927648 | 2023 | Case report | Cureus | Steroid-induced angioedema and urticaria in a patient with atopic dermatitis. |
South Africa Market Information
| Registration Number | Product Name | Dosage Form | Approved Indication |
|---|---|---|---|
| Reg. No. 36/21.5.1/0258 | Budeflam 200 Dp-Caps | Capsule | Not recorded in source data |
| Reg. No. 35/21,5,1/0405 | Symbicord Turbuhaler 60 dose 160mcg/4.5mcg | Tbh | Not recorded in source data |
| Reg. No. A40/21.5.1/0224 | Spec-Budesonide 10 ml 200 dose | Aqs | Not recorded in source data |
| Reg. No. 42/21.5.1/0955 | Arrow Budesonide 2 ml | Vial | Not recorded in source data |
| Reg. No. A39/21.5.1/0506 | Vannair 80/4.5mcg per inhalation 120 dose | Inhaler | Not recorded in source data |
Product names and dosage forms are shown as recorded. Essential Medicines List status is not available in the source data. None of the five registrations is a dermal (topical) formulation.
Safety Considerations
- Drug Interactions: The DDI query returned no records.
Please refer to the SAHPRA-approved Professional Information (PI) for warnings and contraindications. Report adverse drug reactions to SAHPRA.
Safety signals from the literature include:
- Contact and systemic allergy to budesonide: reported in patch-test series and case reports (PMIDs 33931866, 35184304).
- Systemic effects of topical corticosteroids in children: growth and bone/collagen turnover have been studied because of percutaneous absorption (PMIDs 9496795, 8864369).
Conclusion and Next Steps
Decision: Hold
Rationale: The prediction score is very high, but the evidence is L4 (S0, research question). There are no budesonide-specific human efficacy trials in eczema, and the only direct support is a veterinary trial and a preclinical formulation study. The registered forms in South Africa are not dermal, and contact allergy to budesonide is a documented concern.
To proceed, the following is needed:
- SAHPRA Professional Information for each registration, to fill the warnings and contraindications gap (blocking).
- DrugBank mechanism of action data.
- Human clinical evidence of topical budesonide in atopic eczema, such as an RCT or systematic review, and a route-compatibility assessment against the registered forms.
- Merge the duplicate “atopic eczema” and “dermatitis, atopic” predictions.
- Note that the rank 2 prediction, bronchitis (L2, Phase 2 budesonide/formoterol data in bronchiolitis obliterans, Proceed with Guardrails), has far stronger evidence and may deserve priority review. Its indication scope needs to be defined first.
Disclaimer
This content is for research purposes only and does not constitute medical advice. Clinical validation is required before any clinical application.