Budesonide
| Evidence Level: L4 | Predicted Indications: 10 |
Table of Contents
Budesonide: From Approved Corticosteroid Products to Atopic Eczema
One-Sentence Summary
Budesonide is a glucocorticoid marketed in the US as inhaled, oral and nasal-spray products. The source data does not record its approved indications. The TxGNN model predicts it may be effective for atopic eczema, but no clinical trial or paper provided tests budesonide for eczema. Only 2 loosely related trials and 19 mostly indirect publications were found, so this remains a research question.
Quick Overview
| Item | Content |
|---|---|
| Original Indication | Not specified in the provided data (all license records have empty indication text) |
| Predicted New Indication | Atopic eczema (the same concept as “dermatitis, atopic”, rank 3; merge the two entries) |
| TxGNN Prediction Score | 99.96% |
| Evidence Level | L4 |
| US Market Status | ✓ Marketed |
| Number of NDAs | 20 (includes ANDA generics) |
| Recommended Decision | Hold |
Why is This Prediction Reasonable?
Currently, detailed mechanism of action data is not available. Based on general pharmacology, budesonide is a glucocorticoid receptor agonist with broad anti-inflammatory activity. It suppresses pro-inflammatory cytokines and immune cell recruitment in mucosal tissues.
Topical corticosteroids are a standard therapy class for atopic dermatitis, so the mechanism is plausible. One 2024 paper describes budesonide as already applied in local therapy of paediatric atopic dermatitis. It presents this only as background to a formulation study.
The TxGNN score is very high, but it is a knowledge-graph prediction and not clinical evidence. The supplied literature is mostly about contact allergy to budesonide, growth effects of topical steroids, and asthma or eosinophilic esophagitis. That is a caution signal for any dermatologic use.
Clinical Trial Evidence
| Trial Number | Phase | Status | Enrollment | Key Findings |
|---|---|---|---|---|
| NCT04680117 | N/A | Unknown | 150 | Non-interventional study characterising severe paediatric asthma endotypes. Eczema is at most a comorbidity, with no budesonide efficacy readout. |
| NCT01028560 | Phase 1/2 | Completed | 58 | Allergy immunotherapy to prevent asthma morbidity in atopic wheezing children. Budesonide is not the studied intervention. |
Both trials were graded low relevance (C). No trial tests budesonide in atopic eczema.
Literature Evidence
| PMID | Year | Type | Journal | Key Findings |
|---|---|---|---|---|
| 21062310 | 2010 | RCT (veterinary, dogs) | J Vet Pharmacol Ther | A 0.025% budesonide leave-on conditioner reduced skin lesions and pruritus in 29 dogs with atopic dermatitis. Not human evidence. |
| 9496795 | 1998 | Open longitudinal trial | Pediatr Dermatol | Knemometry study of short-term growth in 14 children with atopic dermatitis treated with topical budesonide. This is a systemic-safety study, not an efficacy study. |
| 8864369 | 1996 | Clinical study | Dermatology | Growth and bone turnover markers in children with atopic dermatitis on topical glucocorticoids, raising concern about systemic absorption. |
| 38275852 | 2024 | Preclinical formulation | Gels (Basel) | pH-sensitive budesonide nanoparticles in hydrogels for atopic dermatitis. Formulation work only. |
| 33931866 | 2021 | Patch-test series | Contact Dermatitis | Italian baseline series data. Budesonide is the marker for corticosteroid hypersensitivity, with a decreasing allergy trend. |
| 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 a history of atopic dermatitis. |
| 14616123 | 2003 | Review/study | Allergy | Corticosteroid allergy, including delayed contact allergy, in asthma patients on inhaled steroids. |
| 35133669 | 2022 | Cross-sectional | Contact Dermatitis | Contact sensitization patterns in patients with and without atopic dermatitis. |
| 24603519 | 2014 | Cohort | Dermatitis | Contact hypersensitivity, including to corticosteroid series haptens, in adolescents and adults with atopic dermatitis. |
None of these papers shows that budesonide treats atopic eczema in humans. The remaining papers in the pack are unrelated or indirect: asthma, eosinophilic esophagitis, and general corticosteroid safety reviews.
US Market Information
| Authorization Number | Product Name | Dosage Form | Approved Indication |
|---|---|---|---|
| ANDA205710 | Budesonide (Preferred Pharmaceuticals) | Inhalant | Not listed in source data |
| ANDA078404 | Budesonide Inhalation (Amneal) | Suspension | Not listed in source data |
| ANDA078202 | Budesonide (Nephron) | Inhalant | Not listed in source data |
| NDA021324 | Budesonide (Golden State Medical Supply) | Capsule | Not listed in source data |
| ANDA208851 | Budesonide (Mylan) | Film-coated extended-release tablet | Not listed in source data |
Other authorised forms include delayed-release capsules, metered nasal spray and powder aerosol. No topical dermatologic form appears among the listed authorisations. A skin product would be a new formulation and route.
Safety Considerations
Please refer to the package insert for safety information. The Evidence Pack contains no warnings, contraindications or drug-interaction records (the interaction query found no entries).
Signals from the supplied literature, relevant to dermatologic use:
- Contact and systemic allergy to budesonide is documented in patch-test studies and case reports. It may be more likely in atopic patients exposed to many topical agents.
- Systemic absorption and growth suppression were studied in children with atopic dermatitis on topical glucocorticoids.
- Adrenal (HPA axis) suppression is a known concern with corticosteroids across routes.
Conclusion and Next Steps
Decision: Hold
Rationale: The mechanism is plausible, but there is no interventional human evidence for budesonide in atopic eczema. The supplied trials are unrelated, and the literature is mostly allergy and safety signals plus one preclinical formulation paper. The TxGNN score alone does not justify advancing (L4, stage S0).
To proceed, the following is needed:
- Approved-indication text and package insert warnings and contraindications for the existing US products
- Mechanism-of-action data from DrugBank
- A targeted search for randomised trials of topical budesonide in human atopic dermatitis, and a comparison against established topical corticosteroids
- A route and formulation assessment, since no topical dermatologic budesonide product is listed
- Merging the duplicate “atopic eczema” and “dermatitis, atopic” entries
- A paediatric safety plan covering contact allergy, growth and HPA-axis suppression
Other predictions in the pack: bronchitis (L3, Research Question), with the polyp-type predictions (vocal cord, middle ear, epulis, fibroepithelial, uterine, external auditory canal) at L4-L5 and mostly Hold. Bronchitis overlaps with existing inhaled budesonide use in asthma and COPD, so it may be an on-label extension rather than true repurposing.
This report is for research reference only and does not constitute medical advice. Repurposing candidates require clinical validation before any application.
Disclaimer
This content is for research purposes only and does not constitute medical advice. Clinical validation is required before any clinical application.