Skip to main content

Tarpeyo FDA Approval History

Last updated by Judith Stewart, BPharm on Dec 20, 2021.

FDA Approved: Yes (First approved December 15, 2021)
Brand name: Tarpeyo
Generic name: budesonide
Dosage form: Delayed Release Capsules
Previous Name: Nefecon
Company: Calliditas Therapeutics AB
Treatment for: Primary Immunoglobulin A Nephropathy

Tarpeyo (budesonide) is a targeted release formulation of the approved corticosteroid budesonide indicated to reduce proteinuria in adults with primary immunoglobulin A nephropathy (IgAN).

  • Tarpeyo is indicated to reduce proteinuria in adults with primary immunoglobulin A nephropathy (IgAN) at risk of rapid disease progression, generally a urine protein-to-creatinine ratio (UPCR) ≥ 1.5 g/g. This indication is approved under accelerated approval based on a reduction in proteinuria. It has not been established whether Tarpeyo slows kidney function decline in patients with IgAN. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory clinical trial.
  • IgA nephropathy is a rare kidney disease that occurs when IgA deposits build up in the kidneys. Tarpeyo works by targeting mucosal B-cells which are responsible for the production of galactose-deficient IgA1 antibodies that cause IgA nephropathy.
  • Tarpeyo delayed release capsules are administered orally once daily, in the morning at least 1 hour before a meal.
  • Common adverse reactions include hypertension, peripheral edema, muscle spasms, acne, dermatitis, weight increase, dyspnea, face edema, dyspepsia, fatigue, hirsutism.

Development timeline for Tarpeyo

Dec 15, 2021Approval FDA Approves Tarpeyo (budesonide) to Reduce Proteinuria in IgA Nephropathy
Mar 15, 2021Calliditas Announces Submission of New Drug Application to U.S. FDA for Nefecon in Patients with Primary IgA Nephropathy

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.