Prednisone
| Evidence Level: L3 | Predicted Indications: 10 |
Table of Contents
Prednisone: From Autoimmune and Inflammatory Diseases to Alopecia Areata
One-Sentence Summary
Prednisone is a systemic glucocorticoid originally used for autoimmune and inflammatory conditions (such as Crohn disease, adrenal insufficiency and acute lymphoblastic leukemia). The TxGNN model predicts it may be effective for Alopecia Areata, with no registered clinical trials but 20 publications (including 1 randomized controlled trial of prednisone combined with methotrexate) currently supporting this direction.
Quick Overview
| Item | Content |
|---|---|
| Original Indication | Autoimmune disease (broad indication set including Crohn disease, adrenocortical insufficiency, acute lymphoblastic leukemia and eosinophilic pneumonia; no approved-indication text is available from the US labels) |
| Predicted New Indication | Alopecia areata |
| TxGNN Prediction Score | 99.99% |
| Evidence Level | L3 |
| US Market Status | Cancelled only (all licenses cancelled) |
| Number of NDAs | 12 (all are ANDAs, all cancelled) |
| Recommended Decision | Proceed with Guardrails |
Why is This Prediction Reasonable?
Detailed mechanism of action data is not available for this report. Based on known information, prednisone is a systemic glucocorticoid with broad immunosuppressive and anti-inflammatory effects, including suppression of T-cell activation and cytokine production. Its efficacy in autoimmune and inflammatory diseases is well established.
Alopecia areata is a T-cell-mediated autoimmune attack on hair follicles. Suppressing the immune response is therefore mechanistically plausible and consistent with prednisone’s original autoimmune uses. However, hair regrowth often relapses after the drug is withdrawn, and the toxicity of long-term systemic steroids limits sustained use.
Other predicted indications are much weaker. Alopecia mucinosis and tenosynovitis have only case reports and small series (L4), and the remaining predictions (such as telogen effluvium, folliculitis decalvans and several rare genetic hair disorders) have no supporting evidence and are model predictions only.
Clinical Trial Evidence
Currently no related clinical trials registered.
Literature Evidence
| PMID | Year | Type | Journal | Key Findings |
|---|---|---|---|---|
| 36884234 | 2023 | RCT | JAMA Dermatology | Two-step double-blind trial of methotrexate alone vs methotrexate plus low-dose prednisone in alopecia areata totalis or universalis |
| 1444509 | 1992 | Review | Archives of Dermatology | Review of therapy, efficacy, safety and mechanism in alopecia areata; studies were too heterogeneous to compare |
| 1444500 | 1992 | Randomized controlled trial (per abstract) | Archives of Dermatology | 6-week prednisone taper followed by 2% topical minoxidil or vehicle in 32 patients with mild to extensive disease |
| 791152 | 1976 | Cohort | Archives of Dermatology | 18 patients on alternate-day prednisone; initial response, but long-term benefit not substantial and many side effects |
| 20804894 | 2010 | Cohort | Annales de Dermatologie et de Venereologie | Efficacy and safety of once-monthly oral pulse prednisone |
| 37467740 | 2023 | Case series | Clinical and Experimental Dermatology | Baricitinib plus low-dose corticosteroids gave major improvement in eight patients with very severe disease |
| 41958306 | 2026 | Retrospective case series | JEADV | Baricitinib with low-dose prednisone in very severe alopecia areata |
| 38650498 | 2024 | Real-world observational study | Italian Journal of Dermatology and Venereology | Characterizes comorbidities, treatment patterns and economic burden in hospitalized alopecia areata patients in Italy |
| 8996277 | 1997 | Clinical study | Journal of the American Academy of Dermatology | Systemic cyclosporine plus low-dose prednisone in chronic severe alopecia areata |
| 4684625 | 1973 | Case report | Canadian Medical Association Journal | Short courses of systemic corticosteroids may suffice in alopecia totalis; relapse after stopping is not always rapid |
US Market Information
All 12 US licenses in the data compiled for this report are ANDAs for oral tablets and all are cancelled; approved-indication text is not available. The 5 shown below are examples.
| Authorization Number | Product Name | Dosage Form | Approved Indication |
|---|---|---|---|
| ANDA080352 | PredniSONE (Hikma Pharmaceuticals USA Inc.) | Tablet | Not available |
| ANDA083677 | Prednisone (Mylan Pharmaceuticals Inc.) | Tablet | Not available |
| ANDA040581 | Prednisone (Northwind Health Company, LLC) | Tablet | Not available |
| ANDA219477 | Prednisone delayed release (Dr. Reddys Laboratories Inc.) | Tablet, delayed release | Not available |
| ANDA212629 | PredniSONE Tablets, USP, 5 mg (Bryant Ranch Prepack) | Tablet | Not available |
Safety Considerations
- Disease-level contraindication signals (from the knowledge graph, not label text): hypertension, congestive heart failure, hyperglycemia, epilepsy, herpes simplex virus keratitis, measles, urea cycle disorders (carbamoyl phosphate synthetase I deficiency, citrullinemia, hyperargininemia), and pituitary hormone deficiencies (including hypopituitarism, Sheehan syndrome and Kallmann syndrome).
- Drug Interactions: 100 interactions were identified. The most notable is adalimumab (Major). Moderate interactions include NSAIDs (ibuprofen, ketorolac), nifedipine, ethinylestradiol, acetazolamide, acarbose, albiglutide, isotretinoin, zidovudine, aldesleukin, alemtuzumab, aliskiren and tetanus toxoid vaccine. Minor interactions include formoterol and salbutamol.
- Literature-reported concerns: In alopecia areata studies, long-term systemic steroid use was associated with acne, obesity, lenticular opacities and hypertension, and relapse after withdrawal was common.
Package insert warnings and contraindications were not available for this report; please refer to the package insert for full safety information.
Conclusion and Next Steps
Decision: Proceed with Guardrails
Rationale: The mechanistic rationale is sound and supported by a double-blind randomized trial (prednisone with methotrexate) plus multiple cohort studies and case series. However, there are no registered trials, the evidence is mostly older and observational, benefit is often not sustained after withdrawal, and long-term steroid toxicity is a concern. Evidence is therefore L3 rather than higher.
To proceed, the following is needed:
- FDA package insert warnings and contraindications (currently a blocking gap for safety screening)
- Mechanism of action data from DrugBank
- Confirmation of the current US market status, since all listed licenses are cancelled
- Controlled data on prednisone alone for alopecia areata, with relapse rates after tapering
- A short-course or pulse dosing and safety-monitoring plan to limit steroid toxicity
Disclaimer
This content is for research purposes only and does not constitute medical advice. Clinical validation is required before any clinical application.