What Is Relacorilant?
Relacorilant is an investigational drug that acts as an antiglucocorticoid. This means it works by blocking the effects of cortisol, a hormone naturally produced by the body. By interfering with cortisol's action, Relacorilant aims to manage conditions where there is an excess of this hormone.
Currently, Relacorilant is under development by Corcept Therapeutics for the treatment of Cushing's syndrome, a condition caused by prolonged exposure to high cortisol levels. It is also being studied as an experimental drug in combination with other treatments for various cancers, including prostate cancer, ovarian cancer, and pancreatic cancer. Clinical trials for Relacorilant began in 2016, with the latest trial projected to conclude in 2025.
Uses and Conditions Under Study
Relacorilant is currently being investigated for several conditions, primarily focusing on disorders related to cortisol excess and various cancers.
- Cushing Syndrome and Hypercortisolism: These conditions are characterized by abnormally high levels of cortisol in the body. As an antiglucocorticoid, Relacorilant is being developed to block the effects of this excess cortisol, potentially alleviating symptoms. There are a total of 3 trials studying Cushing Syndrome and 1 trial for Hypercortisolism.
- Cancers: Relacorilant is being studied in combination with other treatments for several types of cancer. This includes 2 trials for Prostate Cancer, 2 trials for Peritoneal Neoplasms, 1 trial for Fallopian Tube Cancer, 1 trial for Fallopian Tube Neoplasms, and 1 trial for Metastatic Pancreatic Ductal Adenocarcinoma. The rationale for its use in these cancers, particularly in heavily pretreated patients with ovarian cancer, is to potentially enhance the effectiveness of chemotherapy.
- Pharmacokinetic and Safety Studies: Several trials are focused on understanding how Relacorilant is processed by the body and its safety profile. These include 6 trials in Healthy volunteers, 1 trial for Food-drug Interaction to assess how food affects its absorption, and 1 trial for Hepatic Impairment to study its effects in individuals with liver issues.
In total, Relacorilant has been studied in 20 clinical trials involving 1,863 participants. Of these, 3 trials are currently recruiting, while 14 trials have been completed.
Dosing
Relacorilant is administered orally, primarily in capsule form. Clinical trials have investigated various formulations and dosing regimens.
The drug has been studied as capsules for oral dosing, including both softgel and hard-shell capsules. Specific strengths investigated include Relacorilant 400 mg (considered a therapeutic dose) and 800 mg (a supra-therapeutic dose) taken once daily. Another strength, 150 mg, has been studied in combination with nab-paclitaxel.
Dosing schedules have varied depending on the condition being studied. For some cancer treatments, Relacorilant has been administered under fed conditions as capsules for oral dosing on the day before, the day of, and the day after nab-paclitaxel infusion. Other studies have explored continuous or intermittent dosing, as well as administration under fasted conditions or after different types of meals (high-fat or low-fat) to understand its absorption characteristics. No specific pediatric doses have been mentioned in the available trial data.
Side Effects
In clinical trials involving approximately 250 patients taking Relacorilant, certain side effects were reported more frequently compared to a placebo group. The most common side effect was nausea, experienced by 26.8% of patients on Relacorilant, compared to 8.9% on placebo. Back pain was also reported by 26.8% of patients taking Relacorilant, versus 14.9% on placebo.
Other common side effects included:
- Pain in extremity: 23.2% on Relacorilant vs 6.9% on placebo
- Peripheral edema (swelling): 23.2% on Relacorilant vs 5.9% on placebo
- Fatigue: 20.0% on Relacorilant vs 9.9% on placebo
- Upper abdominal pain: 14.8% on Relacorilant vs 3.0% on placebo
- Diarrhea: 14.8% on Relacorilant vs 5.9% on placebo
- Dizziness: 13.2% on Relacorilant vs 4.0% on placebo
Some side effects, such as arthralgia (joint pain) at 16.4% on Relacorilant vs 16.8% on placebo, and headache at
Currently Recruiting Trials
Relacorilant is currently being investigated in several clinical trials for various types of cancer. These studies aim to understand how Relacorilant, often in combination with other established treatments, can improve outcomes for patients.
One ongoing study, NCT07259317, is a two-part, Phase 2 investigation sponsored by Corcept Therapeutics. This trial is evaluating Relacorilant in combination with nab-paclitaxel and gemcitabine in patients with metastatic pancreatic adenocarcinoma who have not yet received chemotherapy. Researchers are assessing the safety, tolerability, dosing, and effectiveness of this combination. The study aims to enroll 80 participants with conditions such as adenocarcinoma and pancreatic ductal carcinoma.
Another significant study, NCT06906341, is a Phase 2, open-label, multi-arm global study also sponsored by Corcept Therapeutics. This trial explores Relacorilant in combination with different treatment regimens for patients with gynecological cancers. Specifically, it investigates Relacorilant with nab-paclitaxel and bevacizumab, or Relacorilant with nab-paclitaxel alone. The study is designed to evaluate the efficacy and safety of these combinations for conditions including ovarian cancer, fallopian tube cancer, peritoneal neoplasms, and endometrial cancer, with an enrollment target of 270 patients.
Additionally, the University of Chicago is sponsoring a Phase 2 study, NCT05726292, focusing on high-risk localized prostate cancer. This trial compares enzalutamide plus Relacorilant and androgen deprivation therapy (ADT) against enzalutamide plus placebo and ADT. The goal is to learn about the safety and effectiveness of combining Relacorilant with enzalutamide and hormone therapy for prostate cancer and prostate adenocarcinoma. This study plans to include 90 participants.
Where to Participate
Clinical trials for Relacorilant are available across a wide geographic area, offering opportunities for participation in numerous locations. Currently, there are 33 sites located in 33 cities across 21 states.
Some of the top locations where these studies are being conducted include:
- Birmingham, Alabama
- Scottsdale, Arizona
- Los Angeles, California
- Orange, California
- Palo Alto, California
- San Francisco, California
- Fort Myers, Florida
- Miami Beach, Florida
- West Palm Beach, Florida
- Atlanta, Georgia
To be eligible for these studies, participants must be between 18 and 18 years of age. All genders are welcome to participate, but these trials are not open to healthy volunteers or children, as they focus on specific patient populations with cancer.
Development Timeline
The journey of Relacorilant in clinical development began on May 5, 2016, with its first clinical trial. Since then, the drug has been investigated in a total of 20 trials, enrolling 1,863 participants to date, with the latest trial expected to conclude by December 2, 2025.
Corcept Therapeutics has been the primary driving force behind Relacorilant's development, sponsoring 18 of these trials, while the University of Chicago has sponsored two. The development pipeline shows a progression through various phases, starting with 10 Phase 1 studies to assess initial safety, followed by 5 Phase 2 studies, and 4 Phase 3 studies, alongside one Phase 1/Phase 2 study, indicating a steady advancement towards understanding its potential.
Relacorilant's research initially focused on conditions such as IBS-C and hyperphosphatemia. Over time, the scope of investigation significantly expanded to include a broad range of oncological conditions. This expansion now covers areas such as peritoneal neoplasms, prostate cancer, fallopian tube cancer, ovarian cancer, and endometrial cancer, as well as metastatic pancreatic ductal adenocarcinoma and other solid tumors. This demonstrates a strategic evolution in understanding Relacorilant's potential therapeutic applications across diverse and challenging diseases.