Resmetirom

Category
Details
Specifications
CAS Number
920509-32-6
Molecular Formula
C17H12Cl2N6O4
Molecular Weight
435.22 g/mol.
Synonyms
2-[3,5-dichloro-4-[(6-oxo-5-propan-2-yl-1H-pyridazin-3-yl)oxy]phenyl]-3,5-dioxo-1,2,4-triazine-6-carbonitrile
Chemical Name
2-(3,5-dichloro-4-((5-isopropyl-6-oxo-1,6-dihydro pyridazin-3-yl)oxy)phenyl)-3,5-dioxo-2,3,4,5-tetrahydro-1,2,4-triazine-6-carbonitrile
Therapeutic use
Resmetirom to treat adults with noncirrhotic non-alcoholic steatohepatitis (NASH) who have moderate-to-advanced liver fibrosis (F2-F3 stages). It works as a thyroid hormone receptor-beta (THR-?) agonist to reduce fat accumulation in the liver.
Status
Tech pack available
Background
Resmetirom is a first-in-class, oral, liver-directed thyroid hormone receptor-beta agonist approved in 2024 to treat adults with noncirrhotic non-alcoholic steatohepatitis (NASH/MASH) and moderate-to-advanced fibrosis. By targeting liver.it increases fatty acid oxidation and reduces hepatic fat, offering a solution to reduce liver inflammation and fibrosis
Grade
In house
Polymorph
Form I
Storage Temperature
Controlled room temperature (20?C ? 25?C)

Please Note: We partner exclusively with pharmaceutical manufacturers, biotech companies, and international trading firms. Minimum order quantities apply* 

Disclaimer: 

The information provided on this webpage is based on the best available knowledge at the time of publication; however, accuracy and completeness are not guaranteed. Product specifications may change without notice. It is the responsibility of the purchaser or user to verify suitability and compliance. This product is intended for research use only and is not approved for human consumption.

Resmetirom API (CAS 920509-32-6) is a first-in-class, orally active, liver-directed thyroid hormone receptor-beta (THR-β) agonist developed for the treatment of metabolic dysfunction-associated steatohepatitis (MASH, formerly known as non-alcoholic steatohepatitis or NASH). In 2024 it became the first therapy approved for adults with noncirrhotic MASH and moderate-to-advanced liver fibrosis (F2 to F3), addressing a large and previously unmet clinical need.

With a molecular formula of C₁₇H₁₂Cl₂N₆O₄ and a molecular weight of 435.22 g/mol, resmetirom is a small-molecule active supplied in the crystalline Form I polymorph. By selectively activating the beta isoform of the thyroid hormone receptor in the liver, resmetirom increases hepatic fatty acid oxidation and reduces liver fat, helping to lower steatosis, inflammation, and fibrosis while limiting the systemic effects associated with non-selective thyroid activity. As the first approved MASH therapy, the molecule has driven strong global demand for reliable resmetirom manufacturers and suppliers across regulated and emerging markets.

Shilpa Pharma Lifesciences is among the leading resmetirom manufacturers in India, supplying this small-molecule active as a bulk active pharmaceutical ingredient to pharmaceutical and biotechnology partners worldwide. Backed by a complete technical package and integrated CDMO capabilities, Shilpa Pharma supports global partners from early development through commercial-scale manufacturing and supply.

Resmetirom is supplied as a drug substance (bulk API) for use by pharmaceutical and biotechnology manufacturers in the development and production of oral solid dosage forms for metabolic liver disease. As a once-daily oral THR-β agonist, the molecule acts selectively on hepatic thyroid hormone receptor-beta to increase fatty acid oxidation, reduce intrahepatic triglyceride accumulation, and improve markers of liver steatosis and fibrosis, while also supporting favourable effects on atherogenic lipids such as LDL-cholesterol.

In a development and manufacturing context, the API supports formulation and oral solid dosage (tablet) development, analytical method development and validation, impurity profiling and reference standard qualification, polymorph and stability studies, and scale-up to clinical and commercial supply. The defined crystalline Form I supplied by Shilpa Pharma supports consistent solid-state quality and reproducible processing during oral dosage form development.

As established resmetirom suppliers, Shilpa Pharma provides material exclusively to qualified pharmaceutical manufacturers, biotechnology companies, and international trading partners for development and manufacturing use under applicable regulatory frameworks.

In clinical use, resmetirom is generally well tolerated, with the most commonly reported adverse effects being gastrointestinal in nature, including diarrhoea and nausea; these are typically most frequent at treatment initiation. Because resmetirom is metabolised primarily via CYP2C8, finished-product labelling includes drug-interaction precautions, notably with statins (where resmetirom can increase statin exposure) and with strong CYP2C8 inhibitors. As a therapy for chronic liver disease, product labelling also includes guidance on monitoring for hepatotoxicity. Treatment decisions and dosing are determined by qualified clinicians in accordance with the approved product information.

From a handling and occupational-safety standpoint, resmetirom should be handled by trained personnel using appropriate engineering controls and personal protective equipment in accordance with the product’s Safety Data Sheet (SDS). The API should be stored at controlled room temperature (20°C to 25°C), protected from moisture and light, to maintain stability and quality.

This information is provided for scientific and technical reference to pharmaceutical professionals and does not constitute medical advice.

The cost of resmetirom varies according to order volume, required specifications, packaging, documentation, and delivery destination. As bulk API pricing is project- and quantity-specific, Shilpa Pharma does not publish standard list pricing for this product.

For current resmetirom pricing, bulk quantity cost estimates, and commercial supply terms, pharmaceutical and biotechnology buyers are invited to contact Shilpa Pharma directly. As trusted resmetirom suppliers and exporters, our team provides a tailored quotation based on your required quantity, grade, and regulatory documentation needs, along with competitive, cost-effective supply options for both development-scale and commercial-scale requirements.

Shilpa Pharma Lifesciences is one of the most trusted resmetirom manufacturers in India and a full-scale CDMO partner, supplying high-quality active pharmaceutical ingredients to pharmaceutical and biotech companies across more than 80 countries. For resmetirom, partners choose Shilpa Pharma for:

  • Regulatory-ready manufacturing: produced at cGMP-compliant facilities supported by approvals from USFDA, EU GMP, PMDA, TGA, ANVISA, COFEPRIS, and KFDA.
  • Complete technical package: a ready tech pack that accelerates partner evaluation, formulation development, and regulatory filings.
  • Integrated CDMO capability: end-to-end support from route and process development to analytical characterisation and commercial-scale supply.
  • Solid-state and analytical expertise: defined Form I polymorph control, impurity profiling, and method development for consistent, formulation-ready quality.
  • Reliable global supply: scalable capacity with established export, logistics, and documentation infrastructure, positioning Shilpa Pharma among dependable resmetirom suppliers and exporters for regulated and emerging markets.
  • Confidentiality and partnership: IP-sensitive, transparent collaboration backed by decades of API manufacturing expertise.

Partner with Shilpa Pharma, a trusted resmetirom manufacturer and exporter, for a dependable, scalable, and cost-effective global source of this API.

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Questions & Answers

FAQ on Resmetirom

Everything You Need to Know About Shilpa Pharma

Resmetirom received US FDA accelerated approval in 2024 as the first therapy for noncirrhotic MASH with moderate-to-advanced fibrosis. As an innovator molecule, it remains under patent protection, so commercial generic supply depends on patent expiry and exclusivity in each market. Shilpa Pharma supplies resmetirom API to qualified partners for development, evaluation, and regulatory-readiness purposes under applicable laws.
Resmetirom is indicated for adults with noncirrhotic metabolic dysfunction-associated steatohepatitis (MASH, formerly NASH) who have moderate-to-advanced liver fibrosis (F2 to F3 stages), used alongside diet and exercise. It works to reduce liver fat, inflammation, and fibrosis. Shilpa Pharma supplies the API for formulation development and manufacturing.
Resmetirom selectively activates the beta isoform of the thyroid hormone receptor, which is highly expressed in the liver. This increases hepatic fatty acid oxidation and reduces liver fat, while the beta-selectivity limits the systemic effects associated with non-selective thyroid hormone activity. It is taken once daily as an oral tablet.
Resmetirom carries CAS number 920509-32-6, with the molecular formula C₁₇H₁₂Cl₂N₆O₄ and a molecular weight of 435.22 g/mol. Shilpa Pharma supplies it in the crystalline Form I polymorph, with a complete technical package available on request.
Many developers source innovator molecules early for research, formulation development, and regulatory dossier preparation under research-use and Bolar-type provisions that exist in several markets. As one of the leading resmetirom manufacturers in India, Shilpa Pharma supplies the API to qualified pharmaceutical manufacturers for such development use; buyers should confirm the patent position in each target territory.
Shilpa Pharma supplies resmetirom as the defined crystalline Form I. A consistent, well-characterised polymorph is important for reproducible dissolution, stability, manufacturability, and regulatory acceptance of the finished oral dosage form, which is why solid-state control is a core part of Shilpa Pharma’s offering.
A complete technical package is available now to support evaluation and formulation development. As programs advance toward commercial supply, Shilpa Pharma provides full regulatory documentation support, including Drug Master File and CEP preparation as required, drawing on facilities approved by USFDA, EU GMP, PMDA, TGA, ANVISA, COFEPRIS, and KFDA.
Shilpa Pharma Lifesciences is among the leading resmetirom manufacturers in India and global exporters, supplying the API to pharmaceutical and biotech partners worldwide. Material is offered to qualified manufacturers, biotech companies, and international trading firms for development and manufacturing use.
Yes. Shilpa Pharma’s cGMP-compliant facilities hold approvals for major regulated markets, and the company supplies resmetirom with supporting documentation to partners across the USA, Europe, Japan, and 80+ countries, subject to the applicable regulatory and patent considerations in each market.
Yes. Through its integrated CDMO services, Shilpa Pharma can support the full pathway from route and process development to finished oral solid dosage development, analytical characterisation, polymorph and impurity control, and scale-up from development to commercial volumes, all under a single regulatory umbrella. This positions Shilpa Pharma among the few resmetirom manufacturers offering integrated development-to-commercial supply.

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Please Note: We partner exclusively with pharmaceutical manufacturers, biotech companies, and international trading firms. Minimum order quantities apply*