Product Meta
Country of Origin
India
MEDICINE APPROVED BY
- Indian Medical Agency (IMA)
- Food and Drug Administration (FDA)
- Health Asia
DISEASE INDICATIONS
- European Medical Agency (EMA)
- Food and Drug Administration (FDA)
- Health India
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FREQUENTLY ASKED QUESTIONS
Payments can be made by credit card or bank transfer. Payments are fully encrypted and secure. When paying by credit card, you can pay online once you have received your order confirmation. Please be aware that a 2.8% fee applies when paying by credit card.
Payments can be made by credit card or bank transfer. Payments are fully encrypted and secure. When paying by credit card, you can pay online once you have received your order confirmation. Please be aware that a 2.8% fee applies when paying by credit card.
Payments can be made by credit card or bank transfer. Payments are fully encrypted and secure. When paying by credit card, you can pay online once you have received your order confirmation. Please be aware that a 2.8% fee applies when paying by credit card.
Payments can be made by credit card or bank transfer. Payments are fully encrypted and secure. When paying by credit card, you can pay online once you have received your order confirmation. Please be aware that a 2.8% fee applies when paying by credit card.
Payments can be made by credit card or bank transfer. Payments are fully encrypted and secure. When paying by credit card, you can pay online once you have received your order confirmation. Please be aware that a 2.8% fee applies when paying by credit card.
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Dr. Akshi Sudan
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Dr. Akshi Sudan
Patient Support Team Lead
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Read Full Product Details
What is Rezdiffra?
Rezdiffra is used to treat nonalcoholic steatohepatitis (NASH) in adults who have moderate to advanced liver scarring (fibrosis), but do not have decompensated liver cirrhosis. It is used alongside diet and exercise and is an oral tablet taken 1 time a day.
📘 What It Is
Brand Name: Rezidifra (US: Rezdiffra)
Generic Name: Resmetirom
Drug Class: Selective thyroid hormone receptor‑β (THR‑β) agonist
🏥 Approved Use
Indicated for adults with noncirrhotic nonalcoholic steatohepatitis (NASH) featuring moderate to advanced fibrosis (F2–F3), used alongside diet and exercise
Received accelerated FDA approval on March 14, 2024, with ongoing confirmatory trials.
🧪 How It Works
Resmetirom selectively stimulates THR‑β receptors in the liver to reduce triglycerides and LDL cholesterol and improve liver inflammation and fibrosis
📋 Dosage
Weight‑based once‑daily oral dosing:
<100 kg: 80 mg/day
≥100 kg: 100 mg/day
Available tablet strengths: 60 mg, 80 mg, and 100 mg .
⚠️ Safety & Side Effects
Common: Diarrhea, nausea, constipation, abdominal pain, itch, vomiting, dizziness .
Serious: Hepatotoxicity (monitor liver enzymes, watch for jaundice), gallbladder issues (e.g., gallstones), and pancreatitis .
Avoid in patients with cirrhosis
✅ Clinical Benefit
Phase III trials showed significant resolution of NASH and improvement in fibrosis versus placebo (~30% vs 10%) .
Approval is conditional pending positive long-term outcomes.
Access & Availability
Import (Named Patient/Legal Channels):
Indian Pharma Network (IPN) and Medvitaz Pharma facilitate legal import in cities like Delhi, Mumbai, Bangalore, etc., with doctor prescription and Form 12A/12B import permits .Indian Manufacturing (Future):
Morepen Laboratories has CDSCO clearance to conduct bioequivalence trials for Resmetirom tablets (60 mg, 80 mg, 100 mg), paving the way for local launch .
Dr. Reddy’s manufactures Resmetirom API in Hyderabad .
💡 Summary
Rezidifra (Resmetirom) is the first FDA-approved oral treatment for NASH with fibrosis (F2–F3), a major breakthrough given the lack of approved therapies. It’s weight-based, once-daily, and shows real promise in reducing liver damage.
This content has been reviewed by a Medical Doctor.
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This content has been reviewed by a Medical Doctor.
