Overview of CORT118335
CORT118335, also known as Miricorilant, is a small molecule drug developed by Corcept Therapeutics. It acts as a glucocorticoid receptor (GR) antagonist and mineralocorticoid receptor (MR) antagonist, making it a promising candidate for treating various metabolic and psychiatric disorders[4].
Therapeutic Indications
Non-Alcoholic Fatty Liver Disease (NAFLD) and Non-Alcoholic Steatohepatitis (NASH)
CORT118335 has shown potential in preventing and reversing non-alcoholic fatty liver disease and liver fibrosis in animal models. This is significant because fatty liver disease is a precursor to NASH, a condition that can lead to severe liver damage. Corcept Therapeutics plans to conduct a placebo-controlled Phase 2 trial to evaluate CORT118335 as a treatment for NASH[1].
Antipsychotic-Induced Weight Gain
The drug has been effective in animal models in preventing and reversing weight gain caused by antipsychotic medications such as Zyprexa (olanzapine) and Risperdal (risperidone). Clinical trials are planned to study whether CORT118335 can prevent weight gain in healthy volunteers and reverse weight gain in patients taking antipsychotic medications[1].
Alcohol Use Disorder (AUD)
CORT118335 has been shown to reduce alcohol consumption in individuals with AUD during both acute withdrawal and extended abstinence periods. Corcept Therapeutics has completed a Phase II clinical trial in collaboration with the Scripps Research Institute and the National Institute on Alcohol Abuse and Alcoholism. Additionally, a Phase I clinical trial is underway in partnership with Johns Hopkins University[2].
Clinical Trials and Development Status
- Phase II Trials for AUD: Completed in patients with moderate to severe AUD, with promising results in reducing alcohol consumption[2].
- Phase I Trials for AUD: Ongoing in partnership with Johns Hopkins University[2].
- Phase 2 Trials for NASH: Planned to evaluate the efficacy of CORT118335 in treating NASH[1].
- Phase 2 Trials for Antipsychotic-Induced Weight Gain: Planned to study the prevention and reversal of weight gain in patients taking antipsychotic medications[1].
Market Projections
Alcohol Use Disorder Market
The alcohol use disorder market is expected to show significant growth, driven by increasing awareness and reduced stigma around mental health issues. The market size in the 7MM (seven major markets) was estimated to be USD 620 million in 2023 and is expected to grow further by 2034. CORT118335, with its promising results in clinical trials, is poised to be a key player in this market[2].
Competitive Landscape
CORT118335 will compete with other emerging therapies such as AD04 (ondansetron), CMND-100, and established treatments like Selincro and VIVITROL. The competitive landscape is expected to be dynamic, with multiple companies, including Adial Pharmaceuticals, Clearmind Medicine, and Alkermes, actively developing new treatments for AUD[2][5].
Regulatory and Patent Status
CORT118335 is covered by several U.S. and foreign patents, including composition of matter patents and method of use patents. Corcept Therapeutics continues to apply for additional patents to protect its intellectual property[1].
Market Size and Revenue Projections
The overall market for AUD treatments is projected to grow substantially. For instance, the AD04 market is expected to generate more than USD 200 million by 2032. While specific revenue projections for CORT118335 are not available, its inclusion in the growing AUD treatment market suggests significant potential for revenue growth[5].
Key Takeaways
- Therapeutic Indications: CORT118335 is being developed for NASH, antipsychotic-induced weight gain, and AUD.
- Clinical Trials: Phase II trials for AUD have been completed, and Phase I and Phase 2 trials for other indications are ongoing or planned.
- Market Growth: The AUD market is expected to grow significantly, with CORT118335 positioned as a key treatment option.
- Competitive Landscape: The drug will compete with other emerging and established treatments in the AUD market.
- Regulatory and Patent Status: Protected by multiple patents, with ongoing applications to secure additional intellectual property.
FAQs
What is CORT118335?
CORT118335, or Miricorilant, is a small molecule drug that acts as a glucocorticoid receptor (GR) antagonist and mineralocorticoid receptor (MR) antagonist, developed by Corcept Therapeutics.
What are the primary indications for CORT118335?
The primary indications include non-alcoholic fatty liver disease (NAFLD) and non-alcoholic steatohepatitis (NASH), antipsychotic-induced weight gain, and alcohol use disorder (AUD).
What is the current clinical trial status of CORT118335?
CORT118335 has completed Phase II clinical trials for AUD and is undergoing or planning Phase I and Phase 2 trials for other indications.
How does CORT118335 compare to other treatments in the AUD market?
CORT118335 will compete with other emerging therapies like AD04 and established treatments like Selincro and VIVITROL, but its unique mechanism as a GR antagonist positions it as a promising treatment option.
What are the market projections for the AUD treatment market?
The AUD treatment market is expected to grow significantly, with the market size in the 7MM estimated to be USD 620 million in 2023 and projected to increase by 2034.
Sources
- CORCEPT THERAPEUTICS INCORPORATED - Annual Reports: https://www.annualreports.com/HostedData/AnnualReportArchive/c/NASDAQ_CORT_2018.pdf
- Alcohol Use Disorder Market Set for Remarkable Growth: https://www.globenewswire.com/news-release/2024/12/11/2995656/0/en/Alcohol-Use-Disorder-Market-Set-for-Remarkable-Growth-During-the-Study-Period-2020-2034-DelveInsight.html
- Net Present Value Model: Miricorilant - GlobalData: https://www.globaldata.com/store/report/miricorilant-npv-drug-analysis/
- Miricorilant - Drug Targets, Indications, Patents - Patsnap Synapse: https://synapse.patsnap.com/drug/32982c8894b34a4ca6a908b0679a844b
- Alcohol Use Disorder Treatment Outlook - DelveInsight: https://www.delveinsight.com/blog/alcohol-use-disorder-treatment-market-outlook
Last updated: 2025-01-03
