Madrigal Pharmaceuticals: cross-border access for the specialty portfolio

Quick orientation

Madrigal Pharmaceuticals, Inc. is a US biopharmaceutical company headquartered in West Conshohocken, Pennsylvania. The company developed and commercialises the first FDA-approved therapy for metabolic dysfunction-associated steatohepatitis (MASH), the condition formerly known as NASH. Madrigal trades on NASDAQ as MDGL. FDA approval scale is one marketed product. The pipeline is concentrated in label expansion for resmetirom in liver fibrosis stages and additional indications, with the company having built a focused single-product commercial organisation around Rezdiffra.

Madrigal portfolio in cross-border NPP scope

Rezdiffra (resmetirom) is an FDA-approved oral thyroid hormone receptor-beta (THR-beta) agonist for the treatment of adults with noncirrhotic metabolic dysfunction-associated steatohepatitis (MASH) with moderate to advanced liver fibrosis (consistent with stages F2 to F3 fibrosis), in conjunction with diet and exercise (FDA accelerated approval March 2024). Rezdiffra is the first and only FDA-approved therapy for MASH. Oral dosing, once daily. US list pricing is approximately US$47,400 per year at the standard 80 mg or 100 mg dose depending on body weight. The product is supplied as tablets and is shipped at ambient temperature.

Madrigal's pipeline includes resmetirom for compensated cirrhosis (Phase 3 MAESTRO-NASH OUTCOMES) and additional indication expansions. These are investigational and not in NPP scope.

Why patients route through cross-border NPP

MASH is one of the largest unmet needs in hepatology globally. The estimated prevalence of MASH in the adult population is in the range of three to five percent, and a substantial fraction of those patients have moderate to advanced fibrosis (F2-F3) that places them at significant risk of progression to cirrhosis and hepatocellular carcinoma. Before Rezdiffra, no FDA-approved pharmacological therapy existed for this population; management was limited to lifestyle intervention, weight loss, and management of metabolic comorbidities. The MAESTRO-NASH Phase 3 trial demonstrated MASH resolution and fibrosis improvement at 12 months versus placebo, providing the basis for accelerated approval.

Outside the United States, Rezdiffra is not yet commercially available in most markets. The European Commission marketing authorisation application is under review, and country-by-country reimbursement and launch will follow approval. In the GCC, India, and most of MENA and Southeast Asia, the registration-to-reimbursement timeline is uncertain and likely multi-year. Confirmed-MASH patients with documented F2-F3 fibrosis (typically by transient elastography or liver biopsy) and treating-hepatologist prescription routinely seek cross-border NPP supply as the only available targeted therapy.

Patient profile is typically: documented MASH with non-invasive scoring (FibroScan, FAST score, FIB-4 plus elastography) or biopsy confirming F2-F3 fibrosis; metabolic comorbidities under management (type 2 diabetes, obesity, dyslipidemia); treating-hepatologist prescription; and family or self-pay capacity for ongoing oral therapy at approximately US$47,400 per year landed cost.

Common cross-border destinations

The highest-frequency NPP destinations for Rezdiffra from US-approved inventory are India, the United Arab Emirates, Saudi Arabia, Qatar, and Turkey. Major hepatology centers in Mumbai, Bangalore, Delhi, Dubai, Abu Dhabi, Riyadh, Doha, and Istanbul drive most inbound referrals; the patient flow tracks with the broader Type 2 diabetes and metabolic syndrome epidemiology in these jurisdictions.

Manufacturer engagement posture

Reserve Meds coordinates Madrigal-sourced US commercial product through DSCSA-compliant US specialty distributors. We are not affiliated with Madrigal Pharmaceuticals. Our role is patient-facing coordination on behalf of named individual patients with a verified hepatology prescription. For Madrigal medical affairs or commercial teams interested in cross-border NPP pathways, our BD contact is [email protected].

What Reserve Meds provides

For each Rezdiffra request, Reserve Meds coordinates: prescription verification with the treating hepatologist; documentation review of fibrosis staging (transient elastography or biopsy report); DSCSA serialized chain-of-custody from Madrigal through licensed US wholesalers to the named patient; ambient shipping with appropriate packaging; destination-country regulatory documentation for Ministry of Health named-patient approvals and customs clearance; and a dedicated coordinator from prescription to delivery.

Clinical governance and prescription review

Every prescription for a product on this page is reviewed by a US-licensed pharmacist before dispensing. Reserve Meds does not substitute generic equivalents for branded specialty products without an explicit prescriber instruction, and we do not dispense any product whose chain-of-custody we cannot serialize back to the FDA-authorised manufacturer or its licensed wholesale partner. Our clinical review confirms indication-on-label appropriateness based on the documentation submitted by the treating physician, identifies any standard drug-drug interaction or contraindication concerns, and confirms that the requested dose, dosing schedule, and dosage form match the prescription. Where the prescription is unclear or where the indication on the prescription is off-label, our pharmacist contacts the prescriber directly. We do not provide medical advice to patients beyond drug-information counseling at dispensing.

Supply chain integrity

Supply integrity is the foundation of Reserve Meds operations. Every shipment carries a serialized DSCSA pedigree document confirming the chain of ownership from the FDA-registered manufacturer or its authorised distributor through a licensed US wholesale distributor to Reserve Meds and onward to the named patient. We do not source through parallel-import channels, third-country re-import, or unverified online wholesale markets. Cold-chain shipments are packed in qualified shippers with temperature data-loggers reading and logging temperature throughout the journey; data-logger reads are reviewed on arrival, and any out-of-specification excursion triggers our quality-hold protocol. For frozen products such as gene therapies and certain antibody-drug conjugates, we use validated frozen-shipper systems with dry-ice replenishment as required.

Destination-country regulatory pathways

Cross-border named patient access operates under jurisdiction-specific regulatory frameworks. In the United Arab Emirates, the Ministry of Health and Prevention (MOHAP) and Dubai Health Authority operate import-permit pathways for unregistered or restricted medicines on a named-patient basis. Saudi Arabia, Qatar, Kuwait, Bahrain, and Oman each operate analogous Ministry of Health named-patient frameworks with country-specific documentation requirements. India operates a personal-import pathway under the Drugs and Cosmetics Rules for quantities consistent with personal therapeutic use, typically up to three months supply per shipment. Turkey, Egypt, Jordan, Lebanon, and Morocco each operate distinct named-patient or import-permit pathways. Reserve Meds maintains current regulatory intelligence for each of these jurisdictions and prepares the documentation package required for each shipment.

What to expect through the coordination process

Patients beginning a request receive an initial coordinator contact within one business day of submission. The coordinator reviews the prescription, identifies the documentation required for the destination country, and provides an indicative cost range. Once required documents are uploaded - prescription, prescriber license verification, patient identification, and any indication-specific documentation such as genetic test results or biomarker reports - we issue a firm quote inclusive of product cost, packaging, shipping, regulatory documentation, and our coordination fee. Patients confirm acceptance of the firm quote before any sourcing or shipping is initiated, and Reserve Meds does not collect any deposit at intake. Once the firm quote is accepted and payment is received, the coordinator initiates sourcing through our licensed wholesale partners and prepares the destination-country regulatory package. Typical end-to-end timing from accepted quote to delivery is two to four weeks for ambient-shipped products and three to five weeks for cold-chain shipments, with variability driven by destination-country customs and regulatory turnaround times.

Not affiliated with the manufacturer

Reserve Meds is an independent operator of named patient program coordination. We are not a subsidiary, affiliate, authorised distributor, or licensed representative of any pharmaceutical manufacturer, and no statement on this page should be read as a partnership, endorsement, or representation by the named manufacturer. Trade names and product references on this page are used for informational purposes to identify the FDA-approved products that Reserve Meds coordinates through US specialty wholesale channels on behalf of named individual patients.

Privacy and data handling

Patient data submitted to Reserve Meds is handled under our HIPAA-aligned privacy policy and our destination-country data protection commitments. We minimise data collection to what is necessary for prescription verification, regulatory documentation, and shipping logistics. Patient identifiable information is shared with US wholesalers, destination-country regulatory authorities, and shipping carriers only as required to complete the coordination, and is not used for any marketing purpose.

Next step for patients

Patients with confirmed MASH and F2-F3 fibrosis and a treating-hepatologist prescription for Rezdiffra can begin a request now. Start a Rezdiffra request ›

Next step for Madrigal teams

Madrigal Pharmaceuticals medical affairs or commercial teams interested in cross-border NPP coordination for non-US territories can reach our BD team at [email protected].

Reserved for you.