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NEFECON
Nefecon is a targeted immunosuppressant that delivers budesonide directly to the kidney to reduce inflammation in IgA nephropathy.
Nefecon is a targeted immunosuppressant that delivers budesonide directly to the kidney to reduce inflammation in IgA nephropathy. Used for IgA nephropathy with risk of progression to end-stage renal disease.
At a glance
| Generic name | NEFECON |
|---|---|
| Also known as | Budesonide modified-released capsules (4 mg/capsule), Budesonide modified released capsule |
| Sponsor | Calliditas Therapeutics AB |
| Drug class | Targeted corticosteroid |
| Target | Glucocorticoid receptor (local kidney delivery) |
| Modality | Small molecule |
| Therapeutic area | Nephrology / Immunology |
| Phase | Phase 3 |
Mechanism of action
Nefecon is a novel formulation combining the corticosteroid budesonide with a carrier system designed to target drug delivery to the kidney. It works by locally suppressing immune-mediated inflammation in the glomeruli, specifically addressing the pathogenic IgA immune complex deposition characteristic of IgA nephropathy, while minimizing systemic corticosteroid exposure and associated side effects.
Approved indications
- IgA nephropathy with risk of progression to end-stage renal disease
Common side effects
- Abdominal pain
- Diarrhea
- Nausea
- Hypertension
- Hyperglycemia
Key clinical trials
- Efficacy and Safety of Extended TARPEYO® Treatment Beyond 9 Months in Adult Patients With Primary IgA Nephropathy (PHASE4)
- A Multi-center Open Label Prospective Study on Early Initiation of Targeted-release Formulation of Budesonide in Patients With Primary IgA Nephropathy
- Nefecon and Ambrisentan in IgA Nephropathy (PHASE4)
- Efficacy and Safety in Patients With Primary IgA Nephropathy Who Have Completed Study Nef-301 (Nefigard-OLE) (PHASE3)
- Efficacy and Safety of Nefecon in Patients With Primary IgA (Immunoglobulin A) Nephropathy (PHASE3)
- Efficacy and Safety in Chinese Patients with Immunoglobulin a Nephropathy (IgAN) Who Have Completed Study Nef-301 (PHASE3)
- The Effect of Nefecon® in Patients With Primary IgA Nephropathy at Risk of Developing End-stage Renal Disease (PHASE2)
- Oral Treatment With PL-56 in Patients With IgA Nephropathy - an Explorative Study (PHASE2)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- NEFECON CI brief — competitive landscape report
- NEFECON updates RSS · CI watch RSS
- Calliditas Therapeutics AB portfolio CI