Reata bardoxolone Alport syndrome

Indicated For

Alport syndrome

About This Medication

# Bardoxolone Methyl Patient Guide: How to Get Bardoxolone Methyl at Low or No Cost **Important Notice:** Bardoxolone methyl is an investigational drug not approved by the FDA for any indication. There is no commercial patient assistance program available from Reata Pharmaceuticals or any other source, as the drug remains in clinical trials or development has been discontinued in some regions.[1][3][5] This guide provides information on potential access options like expanded access programs and clinical trials, but eligibility is limited and not based on financial need.[1] ## About Bardoxolone Methyl Bardoxolone methyl is an oral capsule developed by **Reata Pharmaceuticals** as a potential treatment for **chronic kidney disease (CKD)**, including conditions like Alport syndrome, diabetic kidney disease, and autosomal dominant polycystic kidney disease (ADPKD).[1][3][4][6] It works as an antioxidant inflammation modulator that activates Nrf2 pathways to potentially improve kidney function and slow disease progression.[2][4] Doses in trials start at 5 mg daily, escalating up to 20-30 mg based on patient response and urine albumin-to-creatinine ratio (UACR).[1] Common side effects reported in trials include nausea, weight loss, and muscle spasms. It has shown risks, especially for patients with heart disease, and was linked to safety concerns leading to trial halts or FDA rejections.[3][4] The FDA issued a Complete Response Letter in 2021 rejecting approval for Alport syndrome CKD due to insufficient efficacy and safety data.[3] Development was discontinued in Japan for diabetic kidney disease in 2023.[5] As of now, bardoxolone is **only available through clinical trials or expanded access programs**, not pharmacies.[4] ## Who Qualifies for Access? Since there is **no standard prescription assistance program (PAP)** for bardoxolone methyl—program name, income thresholds, and application details are not available—access is restricted to research settings.[1][4] Qualification focuses on medical criteria, not finances: - Participation in prior bardoxolone trials without safety discontinuations.[1] - Specific CKD diagnoses like Alport syndrome or ADPKD with potential benefit-risk.[1][3][6] - No ongoing serious adverse events (SAEs) or heart disease history.[1][4] - Agreement to contraception for those of childbearing potential.[1] Financial assistance is not a feature; trial enrollment is typically free, covering drug and monitoring costs for qualified patients.[1] ## Income Eligibility Breakdown **No income-based eligibility exists** for bardoxolone access, as it is not a commercial PAP. The table below reflects the lack of financial criteria: | Household Size | Income Threshold | FPL % | Notes | |---------------|------------------|-------|-------| | Individual | Not Applicable | N/A | Trial access medical only[1][4] | | Couple | Not Applicable | N/A | No PAP available | | Family of 3 | Not Applicable | N/A | Investigational drug[3] | | Family of 4 | Not Applicable | N/A | Contact manufacturer for trials | Patients should not expect low/no-cost access outside trials, where costs are sponsor-covered. ## Insurance Requirements **Insurance is not required** for clinical trial or expanded access participation, as sponsors like Reata provide the drug free to enrollees.[1][4] Medicare or private insurance does not cover investigational drugs outside approved uses. If approved in the future, requirements would be specified then—currently, none apply.[3] ## Step-by-Step Application Process 1. **Consult Your Doctor:** Discuss with a nephrologist experienced in CKD trials. They assess if you meet criteria like prior trial participation or specific CKD stage.[1] 2. **Search Clinical Trials:** Use ClinicalTrials.gov to find active bardoxolone studies (e.g., NCT03749447 for extended access in CKD).[1] Check for expanded access programs.[1] 3. **Contact Reata Pharmaceuticals:** Reach out via their website or clinical development team for enrollment info. No dedicated PAP phone or URL exists.[4] 4. **Submit Medical Records:** Provide history, labs (e.g., UACR >300 mg/g), and exclusion checks (no SAEs, contraception plan).[1] 5. **Investigator Review:** Site principal investigator approves based on benefit-risk.[1] 6. **Enroll and Start:** If accepted, receive drug at trial site; no home delivery typically.[1] No standard application method, phone, or URL for PAP—use trial portals.[1] ## Timeline and Delivery Processing time varies: trial screening may take weeks; expanded access faster if eligible.[1] Delivery is site-administered, not mailed—no specified method.[1] Treatment duration can be long-term in extended access.[1] Expect on-site pickup or clinic dosing. ## Alternatives if Denied or Ineligible - **Other CKD Trials:** Search ClinicalTrials.gov for kidney-protective agents. - **Approved CKD Drugs:** SGLT2 inhibitors (e.g., dapagliflozin) or finerenone, covered by many PAPs if uninsured. - **General Assistance:** NeedyMeds.org or RxAssist.org for approved meds; Medicare Extra Help for low-income. - **Biosimilars:** None available.[ ] Contact Reata for compassionate use inquiries if trials unavailable.[4] ## Disclaimer This guide is for informational purposes only and not medical advice. Bardoxolone methyl is experimental; risks include heart issues and unproven efficacy.[3][4] Consult healthcare providers before pursuing. Availability changes—verify via ClinicalTrials.gov. Reata Pharmaceuticals holds no public PAP; details based on latest data as of 2026.[1][5] Word count: 942

Program information last verified: March 30, 2026