Nephrology
IgA nephropathy: the approved drugs compared for prescribers
Fabhalta, Filspari, Tarpeyo side by side on what each first fill waits on, what the label requires you to monitor and what an insurer asks to see, with FDA decisions, label changes and open trials for IgA nephropathy.
3prescribing companions
1FDA decision pending
91open or opening studies
November 7, 2026last checked
The drugs side by side
Each cell is a summary of that drug's prescribing companion, which carries the full detail and a source on every line. Insurer thresholds are one public policy shown as an example; plans differ.
| Fabhaltaiptacopan | Filsparisparsentan | Tarpeyobudesonide delayed-release capsules | |
|---|---|---|---|
| Label dated | July 16, 2026 | April 9, 2026 | January 21, 2026 |
| Starting dose | 200mg twice daily, swallowed whole, with or without food; never opened, broken or chewed. A 60-capsule bottle is a 30-day supply. | 200mg once daily, swallowed whole with water before the same meal each day, morning or evening. Tablets may be crushed into half a cup of water immediately before the dose; no other liquid, no storage of the mixture. | 16mg once daily as four 4mg delayed-release capsules, in the morning, at least 1 hour before a meal, swallowed whole; never opened, crushed or chewed. A 120-capsule bottle is a 30-day supply. |
| Dispensing gate | REMS-certified prescriber, pneumococcal and meningococcal (ACWY and B) vaccination at least 2 weeks before day 1 or antibacterial prophylaxis with vaccines as soon as possible, counseling with the Patient Safety Card, and the pharmacy's documentation of vaccination status with the office | REMS-certified prescriber and pharmacy, REMS enrollment form, baseline ALT, AST and bilirubin, and a negative pregnancy test where it applies, before the first ship | Tarpeyo Touchpoints enrollment form signed by patient and prescriber, hepatitis B screen, and the prescription routed to PANTHERx Rare Pharmacy, the only dispensing pharmacy |
| Required monitoring | Serious infection with encapsulated bacteria at any time, lipids periodically, boosters on the ACIP schedule for a complement inhibitor for as long as treatment lasts | ALT, AST and bilirubin at baseline and every 3 months for the length of treatment; the REMS blocks refills without them | No REMS and no gated lab; the label asks for hepatitis B screening before starting, monitoring of the conditions a corticosteroid can worsen, and a 2-week taper to 8mg a day at the end of the 9-month course |
| Example PA threshold | FEP example: biopsy, UPCR 1.5g/g or higher in a policy written before the July 2026 full approval removed that bar from the label, maximum ACEi or ARB dose, eGFR 20 or higher, vaccines and REMS enrollment | Express Scripts example: biopsy, proteinuria above 1g a day or UPCR 1.5g/g or higher, 12 weeks at the maximum tolerated ACEi or ARB dose, eGFR 30 or higher | Express Scripts example: biopsy, proteinuria 0.5g a day or UPCR 0.8g/g or higher, 90 days at the maximum tolerated ACEi or ARB dose, eGFR 30 or higher, no prior course |
| Support line | Novartis Patient Support, 1-833-993-2242, one named team member, Co-Pay Plus to $0 for commercial plans plus $1,000 a year toward vaccines, free drug for up to 12 months while a commercial plan decides, in-home vaccination; REMS helpline 1-866-201-3101 | Travere TotalCare, 1-833-345-7727, nurse educator, $0 copay for commercial plans, free at-home REMS liver draws for eligible patients | Tarpeyo Touchpoints, 1-833-444-8277, Care Navigator, copay assistance to $0 for commercial plans, delivery through PANTHERx with refill calls |
Fabhalta iptacopan
- Label dated
- July 16, 2026
- Starting dose
- 200mg twice daily, swallowed whole, with or without food; never opened, broken or chewed. A 60-capsule bottle is a 30-day supply.
- Dispensing gate
- REMS-certified prescriber, pneumococcal and meningococcal (ACWY and B) vaccination at least 2 weeks before day 1 or antibacterial prophylaxis with vaccines as soon as possible, counseling with the Patient Safety Card, and the pharmacy's documentation of vaccination status with the office
- Required monitoring
- Serious infection with encapsulated bacteria at any time, lipids periodically, boosters on the ACIP schedule for a complement inhibitor for as long as treatment lasts
- Example PA threshold
- FEP example: biopsy, UPCR 1.5g/g or higher in a policy written before the July 2026 full approval removed that bar from the label, maximum ACEi or ARB dose, eGFR 20 or higher, vaccines and REMS enrollment
- Support line
- Novartis Patient Support, 1-833-993-2242, one named team member, Co-Pay Plus to $0 for commercial plans plus $1,000 a year toward vaccines, free drug for up to 12 months while a commercial plan decides, in-home vaccination; REMS helpline 1-866-201-3101
Filspari sparsentan
- Label dated
- April 9, 2026
- Starting dose
- 200mg once daily, swallowed whole with water before the same meal each day, morning or evening. Tablets may be crushed into half a cup of water immediately before the dose; no other liquid, no storage of the mixture.
- Dispensing gate
- REMS-certified prescriber and pharmacy, REMS enrollment form, baseline ALT, AST and bilirubin, and a negative pregnancy test where it applies, before the first ship
- Required monitoring
- ALT, AST and bilirubin at baseline and every 3 months for the length of treatment; the REMS blocks refills without them
- Example PA threshold
- Express Scripts example: biopsy, proteinuria above 1g a day or UPCR 1.5g/g or higher, 12 weeks at the maximum tolerated ACEi or ARB dose, eGFR 30 or higher
- Support line
- Travere TotalCare, 1-833-345-7727, nurse educator, $0 copay for commercial plans, free at-home REMS liver draws for eligible patients
Tarpeyo budesonide delayed-release capsules
- Label dated
- January 21, 2026
- Starting dose
- 16mg once daily as four 4mg delayed-release capsules, in the morning, at least 1 hour before a meal, swallowed whole; never opened, crushed or chewed. A 120-capsule bottle is a 30-day supply.
- Dispensing gate
- Tarpeyo Touchpoints enrollment form signed by patient and prescriber, hepatitis B screen, and the prescription routed to PANTHERx Rare Pharmacy, the only dispensing pharmacy
- Required monitoring
- No REMS and no gated lab; the label asks for hepatitis B screening before starting, monitoring of the conditions a corticosteroid can worsen, and a 2-week taper to 8mg a day at the end of the 9-month course
- Example PA threshold
- Express Scripts example: biopsy, proteinuria 0.5g a day or UPCR 0.8g/g or higher, 90 days at the maximum tolerated ACEi or ARB dose, eGFR 30 or higher, no prior course
- Support line
- Tarpeyo Touchpoints, 1-833-444-8277, Care Navigator, copay assistance to $0 for commercial plans, delivery through PANTHERx with refill calls
FDA decisions for IgA nephropathy
From the Trial Friend FDA decision calendar, which records each date from the sponsor's or the FDA's own announcement.
- November 30, 2026Povetacicept, BLA, Vertex PharmaceuticalsPending
- October 21, 2026Ultomiris (ravulizumab), sBLA, AstraZeneca (Alexion)Approved
- July 16, 2026Fabhalta (iptacopan), sNDA, NovartisApproved
- July 7, 2026Trutakna (atacicept), BLA, Vera TherapeuticsApproved
Recent label changes
What changed in each label revision, from the FDA's approval letters and the labels' own revision lists.
- July 2026Fabhalta. Full approval for IgA nephropathy. The use changed from reducing protein in the urine in people with a protein ratio of 1.5g/g or more to slowing kidney function decline in adults at risk of progression. The 1.5g/g bar left the label. Insurer policies written before this still quote it. FDA letter
- April 2026Filspari. The FSGS use was added, with its own doses (400mg rising to 800mg for people over 50kg), and the dosing and warnings sections were revised with it. The IgAN dose did not change. FDA label
- January 2026Tarpeyo. The current label carries this date. Drugs@FDA lists no new approved supplement for it, so the FDA-approved changes on record remain the ones below. FDA label
- August 2025Filspari. The boxed warning was revised. This is the revision after which the required liver tests run every 3 months throughout treatment. Older patient references still describe monthly tests for the first year, which was the earlier rule, so a nurse or pharmacist reading from an old handout may say monthly. FDA label
- March 2025Fabhalta. Complement 3 glomerulopathy was added as a third use, to reduce protein in the urine. The IgAN dose and rules did not change. FDA letter
- August 2024Fabhalta. Accelerated approval for IgA nephropathy, to reduce protein in the urine in adults at risk of rapid progression, with a required trial to confirm the benefit. The REMS Patient Guide was updated to say that earlier vaccinations may not be enough before starting. FDA letter
- June 2024Tarpeyo. The infection warning was expanded after an FDA letter to the whole corticosteroid class. It added the risk of waking latent infections such as hepatitis B, tuberculosis and certain parasites, and a note on Kaposi's sarcoma. The FDA's letter says the Patient Information did not change. FDA letter
- March 2024Fabhalta. The Hib vaccine requirement was removed after an FDA letter to the complement inhibitor class, leaving pneumococcal and meningococcal vaccination. FDA letter
Open trials
91
Screen a patient against themstudies listing IgA Nephropathy are recruiting or about to open on ClinicalTrials.gov
Counted live, at most once a day
A reference for licensed professionals, checked on November 7, 2026. Labels and plan policies change; the label on DailyMed and the plan's current policy govern. Not medical advice. For patients: the IgA nephropathy page and the first 90 days pages for Fabhalta, Filspari, Tarpeyo.