You're using a free limited version of DrugPatentWatch: Upgrade for Complete Access

Last Updated: June 20, 2025

Investigational Drug Information for CORT118335


✉ Email this page to a colleague

« Back to Dashboard


What is the development status for investigational drug CORT118335?

CORT118335 is an investigational drug.

There have been 12 clinical trials for CORT118335. The most recent clinical trial was a Phase 1 trial, which was initiated on October 25th 2023.

The most common disease conditions in clinical trials are Non-alcoholic Fatty Liver Disease, Fatty Liver, and Weight Gain. The leading clinical trial sponsors are Corcept Therapeutics, National Institute on Alcohol Abuse and Alcoholism (NIAAA), and The Scripps Research Institute.

There are five US patents protecting this investigational drug and sixty international patents.

Recent Clinical Trials for CORT118335
TitleSponsorPhase
A Phase 2b, Study Evaluating Miricorilant in Adult Patients With Nonalcoholic Steatohepatitis/Metabolic Dysfunction-Associated Steatohepatitis (MONARCH)Corcept TherapeuticsPhase 2
Study to Evaluate the Effects of a Cytochrome P450 2C19 Inhibitor on the Pharmacokinetics of MiricorilantCorcept TherapeuticsPhase 1
Phase 1 Study to Evaluate the Effects of Hepatic Impairment on the Pharmacokinetics of MiricorilantCorcept TherapeuticsPhase 1

See all CORT118335 clinical trials

Clinical Trial Summary for CORT118335

Top disease conditions for CORT118335
Top clinical trial sponsors for CORT118335

See all CORT118335 clinical trials

US Patents for CORT118335

Drugname Patent Number Patent Title Patent Assignee Estimated Expiration
CORT118335 ⤷  Try for Free Treatment and differential diagnosis of Cushing's disease and ectopic Cushing's syndrome Corcept Therapeutics, Inc. (Menlo Park, CA) ⤷  Try for Free
CORT118335 ⤷  Try for Free Fatty liver disease treatment using glucocorticoid and mineralocorticoid receptor antagonists Corcept Therapeutics, Inc. (Menlo Park, CA) ⤷  Try for Free
CORT118335 ⤷  Try for Free Pyrimidine cyclohexyl glucocorticoid receptor modulators Corcept Therapeutics, Inc. (Menlo Park, CA) ⤷  Try for Free
CORT118335 ⤷  Try for Free Pyrimidine cyclohexyl glucocorticoid receptor modulators Corcept Therapeutics, Inc. (Menlo Park, CA) ⤷  Try for Free
>Drugname >Patent Number >Patent Title >Patent Assignee >Estimated Expiration

International Patents for CORT118335

Drugname Country Document Number Estimated Expiration Related US Patent
CORT118335 Australia AU2017210156 2036-01-19 ⤷  Try for Free
CORT118335 Canada CA3011728 2036-01-19 ⤷  Try for Free
CORT118335 European Patent Office EP3405101 2036-01-19 ⤷  Try for Free
CORT118335 Spain ES2861524 2036-01-19 ⤷  Try for Free
>Drugname >Country >Document Number >Estimated Expiration >Related US Patent

Development Update and Market Projections for CORT118335

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

  1. CORCEPT THERAPEUTICS INCORPORATED - Annual Reports: https://www.annualreports.com/HostedData/AnnualReportArchive/c/NASDAQ_CORT_2018.pdf
  2. 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
  3. Net Present Value Model: Miricorilant - GlobalData: https://www.globaldata.com/store/report/miricorilant-npv-drug-analysis/
  4. Miricorilant - Drug Targets, Indications, Patents - Patsnap Synapse: https://synapse.patsnap.com/drug/32982c8894b34a4ca6a908b0679a844b
  5. Alcohol Use Disorder Treatment Outlook - DelveInsight: https://www.delveinsight.com/blog/alcohol-use-disorder-treatment-market-outlook
Last updated: 2025-01-03

More… ↓

⤷  Try for Free

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.