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Last Updated: January 20, 2025

Investigational Drug Information for Aramchol


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What is the development status for investigational drug Aramchol?

Aramchol is an investigational drug.

There have been 13 clinical trials for Aramchol. The most recent clinical trial was a Phase 2 trial, which was initiated on September 23rd 2019.

The most common disease conditions in clinical trials are Liver Diseases, Fatty Liver, and Non-alcoholic Fatty Liver Disease. The leading clinical trial sponsors are Galmed Pharmaceuticals Ltd, Galmed Research and Development, Ltd., and Diamond Pharma Services Regulatory Affairs Consultancy.

There are eleven US patents protecting this investigational drug and three hundred and fifty-five international patents.

Recent Clinical Trials for Aramchol
TitleSponsorPhase
A Study Evaluating the Safety, Tolerability, and Efficacy of Aramchol Meglumine in Primary Sclerosing CholangitisVirginia Commonwealth UniversityPhase 2
A Study Evaluating the Safety, Tolerability, and Efficacy of Aramchol Meglumine in Primary Sclerosing CholangitisGalmed Research and Development, Ltd.Phase 2
An Open-Label, Two-Part Study Designed to Assess the Absolute Bioavailability and Mass Balance of AramcholQuotient SciencesPhase 1

See all Aramchol clinical trials

Clinical Trial Summary for Aramchol

Top disease conditions for Aramchol
trials011223344Liver DiseasesFatty LiverNon-alcoholic Fatty Liver Disease[disabled in preview]
Top clinical trial sponsors for Aramchol
trials01234567Galmed Pharmaceuticals LtdGalmed Research and Development, Ltd.Diamond Pharma Services Regulatory Affairs Consultancy[disabled in preview]

See all Aramchol clinical trials

US Patents for Aramchol

DrugnamePatent NumberPatent TitlePatent AssigneeEstimated Expiration
Aramchol ⤷  Subscribe Carbamoyloxymethyl triazole cyclohexyl acids as LPA antagonists Bristol-Myers Squibb Company (Princeton, NJ) Syngene International Limited (Bangalore, Karnataka, IN) ⤷  Subscribe
Aramchol ⤷  Subscribe Controlled release dosage form TRIASTEK, INC. (Nanjing, CN) ⤷  Subscribe
Aramchol ⤷  Subscribe Monocyclic compound Takeda Pharmaceutical Company Limited (Osaka, JP) ⤷  Subscribe
>Drugname>Patent Number>Patent Title>Patent Assignee>Estimated Expiration
Showing 1 to 3 of 3 entries

International Patents for Aramchol

DrugnameCountryDocument NumberEstimated ExpirationRelated US Patent
Aramchol Argentina AR108838 2036-06-21 ⤷  Subscribe
Aramchol Australia AU2017281439 2036-06-21 ⤷  Subscribe
Aramchol Australia AU2021209334 2036-06-21 ⤷  Subscribe
>Drugname>Country>Document Number>Estimated Expiration>Related US Patent
Showing 1 to 3 of 3 entries

Development Update and Market Projection for the Drug Candidate: Aramchol

Introduction to Aramchol

Aramchol, developed by Galmed Pharmaceuticals Ltd., is a promising drug candidate primarily targeted at treating liver, metabolic, and fibro-inflammatory diseases. Here, we will delve into the recent development updates and market projections for Aramchol.

Current Development Status

Phase 3 Trials for NASH and Fibrosis

Galmed has recently published the one-year results of the Open-Label part (ARCON) of its global Phase 3 trial of Aramchol in 150 patients with Non-Alcoholic Steatohepatitis (NASH) and fibrosis, known as the ARMOR study. These results, published in the journal Hepatology, demonstrated significant histological fibrosis improvement in patients treated with Aramchol 300mg BID (twice daily)[1][4].

Clinical Development for Primary Sclerosing Cholangitis (PSC)

In addition to NASH, Galmed has initiated a clinical development program to evaluate Aramchol meglumine for the treatment of Primary Sclerosing Cholangitis (PSC), a rare chronic cholestatic liver disease. This single-arm, open-label, proof-of-concept clinical trial will assess the effects of 24 weeks of treatment in approximately 15 patients with PSC. The study will include various endpoints such as laboratory parameters, imaging, and histological fibrosis to provide a comprehensive assessment of the disease and the treatment's efficacy[3].

Expansion into Other Indications

Cancer and Cardiometabolic Diseases

Galmed is expanding its activities to include cancer and major cardiometabolic diseases. One program aims to identify novel Aramchol-based drug combinations to overcome resistance to standard-of-care oncological treatments for patients with advanced colorectal and hepatic cancers. Another program focuses on developing Aramchol-based drug combinations targeting cardiac fibrosis, which is associated with various cardiovascular diseases. New data from in-vitro and ex-vivo studies in these programs are expected to be released in the fourth quarter of 2024[5].

Market Projections

Non-Alcoholic Steatohepatitis (NASH) Market

The NASH treatment market is expected to grow significantly, driven by the increasing prevalence of the disease and the lack of approved treatments. By 2025, the NASH treatment market is estimated to be around USD 7.07 billion, with a projected growth rate of 18.2% from 2025 to 2037, reaching USD 50.5 billion by 2037. Aramchol, with its promising Phase 3 results, is well-positioned to capture a substantial share of this growing market[2].

Competitive Landscape

The NASH treatment market is highly competitive, with several drugs in various stages of development, including Vitamin E and Pioglitazone, Obeticholic Acid, Lanifibranor, Semaglutide, and Resmetirom. However, Aramchol's unique mechanism of action and its robust clinical data make it a strong contender in this space.

Expert Insights

Prof. Arun Sanyal, Director of the Stravitz-Sanyal Institute for Liver Disease and Metabolic Health at Virginia Commonwealth University, highlighted the significant unmet need for effective therapeutics in PSC and expressed excitement about testing Aramchol's new metabolically driven therapeutic approach for this condition[3].

Allen Baharaff, CEO and President of Galmed Pharmaceuticals, emphasized the promising clinical potential of Aramchol not only for NASH and PSC but also for other fibrotic liver indications and even inflammatory bowel disease (IBD)[3].

Key Takeaways

  • Clinical Success: Aramchol has shown significant histological fibrosis improvement in patients with NASH and fibrosis in Phase 3 trials.
  • Expansion: Galmed is exploring Aramchol's potential in treating PSC, cancer, and cardiometabolic diseases.
  • Market Growth: The NASH treatment market is projected to grow substantially, with Aramchol poised to be a major player.
  • Competitive Edge: Aramchol's unique mechanism and robust clinical data position it favorably in a competitive market.

FAQs

What is Aramchol primarily used for?

Aramchol is primarily being developed for the treatment of Non-Alcoholic Steatohepatitis (NASH) and fibrosis, as well as other liver diseases such as Primary Sclerosing Cholangitis (PSC).

What are the recent clinical trial results for Aramchol in NASH?

The one-year results of the Open-Label part of the Phase 3 trial (ARMOR study) showed a high rate of subjects with histological fibrosis improvement when treated with Aramchol 300mg BID.

Is Aramchol being explored for other indications?

Yes, Galmed is expanding its activities to include the development of Aramchol for cancer and major cardiometabolic diseases, such as cardiac fibrosis.

What is the projected market size for NASH treatments by 2037?

The NASH treatment market is projected to reach USD 50.5 billion by 2037, growing at a rate of 18.2% from 2025 to 2037.

Who is collaborating with Galmed on the PSC clinical trial?

The PSC clinical trial is being conducted in collaboration with the Stravitz-Sanyal Institute for Liver Disease and Metabolic Health at Virginia Commonwealth University.

Sources

  1. Galmed Pharmaceuticals Ltd. - "Galmed publishes Results from Aramchol Phase 3 Open Label part in Hepatology" - PR Newswire, September 25, 2024.
  2. Research Nester - "Non-alcoholic Steatohepatitis Treatment Market Forecast Report 2037".
  3. Galmed Pharmaceuticals Ltd. - "Galmed Announces Initiation of a Clinical Development Program to Evaluate Aramchol Meglumine for the Treatment of Primary Sclerosing Cholangitis (PSC)" - PR Newswire, May 9, 2023.
  4. Galmed Pharmaceuticals Ltd. - "Galmed publishes Results from Aramchol Phase 3 Open Label part in Hepatology" - PR Newswire, September 25, 2024.
  5. Galmed Pharmaceuticals Ltd. - "Galmed Announces an Expansion of its Activities to Cancer and major Cardiometabolic Diseases" - Investor Room, September 19, 2024.

More… ↓

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