What Is INCB123667?
INCB123667 is a drug currently under investigation in clinical trials. The specific mechanism by which INCB123667 works is not detailed in the available trial descriptions. However, trial data indicates it is administered orally, often as a tablet or an oral solution. It is being studied by Incyte Corporation.
INCB123667 is being investigated for several conditions. Clinical trials are exploring its potential use in patients with Ovarian Cancer, as well as in individuals with Hepatic Insufficiency, Liver Diseases, and Renal Impairment. Some studies also involve healthy participants to understand how the drug is processed by the body and how it interacts with other medications.
A total of 6 clinical trials have been conducted or are currently underway for INCB123667, enrolling a total of 718 participants. Of these, 3 trials are actively recruiting new participants, while 1 trial has been completed. The first trial began on April 3, 2025, and the latest trial is expected to conclude by April 30, 2026.
Uses and Conditions Under Study
INCB123667 is being investigated across a range of conditions, with studies designed to understand both its therapeutic effects and how the body processes the drug.
Ovarian Cancer: Two clinical trials are investigating INCB123667 for patients with ovarian cancer. Ovarian cancer is a type of cancer that begins in the ovaries. While the specific role of INCB123667 in treating ovarian cancer is not detailed, these studies aim to evaluate its safety and effectiveness in this patient population.
Liver Function Impairment: The drug is also being studied in individuals with liver-related conditions. One trial focuses on Hepatic Insufficiency, which refers to the inability of the liver to perform its normal functions. Another trial broadly examines Liver Diseases. These studies help determine how liver function affects the drug's metabolism and dosing requirements, ensuring safe administration for patients with compromised liver health.
Kidney Function Impairment: One trial is dedicated to patients with Renal Impairment, which means reduced kidney function. The kidneys play a crucial role in filtering waste products from the blood and excreting drugs. Understanding how INCB123667 behaves in individuals with impaired kidney function is vital for establishing appropriate dosing and preventing potential side effects.
Healthy Participants: Two trials involve healthy participants. These studies are typically conducted early in drug development to assess the drug's pharmacokinetics (how the body absorbs, distributes, metabolizes, and excretes the drug) and pharmacodynamics (what the drug does to the body), as well as its general safety profile before it is widely tested in patient populations.
Dosing
INCB123667 has been studied in various oral dosage forms and administration schedules during its clinical development.
The drug is primarily administered orally. Trial descriptions indicate it has been given as a single oral dose in some studies, while others involve administration twice daily (BID). Both tablet forms and oral solutions of INCB123667 have been investigated.
Clinical trials have explored different dosing scenarios to understand how the drug behaves under various conditions:
- Studies have evaluated INCB123667 in patients with varying degrees of kidney function, including those with severe renal impairment and end stage renal disease.
- Dosing has also been assessed in individuals with different levels of liver function, specifically in cohorts with moderate and severe hepatic function.
- The impact of food on absorption has been examined, with studies comparing INCB123667 administration in both fasted and fed states.
- Drug-drug interactions are also being investigated, with specific cohorts studying INCB123667 when co-administered with other medications such as itraconazole and carbamazepine.
These varied dosing studies help establish safe and effective administration guidelines for future use of INCB123667 across diverse patient populations and treatment regimens.
Side Effects
In a placebo-controlled study involving patients with irritable bowel syndrome with constipation (IBS-C), the most common side effect reported by patients taking INCB123667 was nausea. 11.6% of patients experienced nausea, compared to 4.0% of patients on placebo.
Other common side effects observed in patients taking INCB123667, compared to placebo, included:
- Abdominal pain: 8.5% vs 6.0% on placebo
- Diarrhea: 8.2% vs 2.7% on placebo
- Vomiting: 6.8% vs 2.7% on placebo
- Headache: 6.5% vs 5.0% on placebo
- Dizziness: 4.8% vs 2.3% on placebo
- Fatigue: 4.8% vs 2.7% on placebo
In a separate open-label study involving patients with hyperphosphatemia on dialysis, adverse events were also reported. These events did not have a placebo comparison. The most frequently reported events in this population included AV fistula complication (20%), hyperkalemia (10%), hypertension (10%), nausea (10%), vomiting (10%), diarrhea (10%), dizziness (10%), and headache (10%).
Clinical Trial Results
Results in Irritable Bowel Syndrome with Constipation (IBS-C)
A Phase 2, double-blind, placebo-controlled study (NCT04107122) evaluated INCB123667 in patients with irritable bowel syndrome with constipation. The study enrolled 293 patients in the INCB123667 arm and 299 patients in the placebo arm. The primary goal was to assess the overall responder rate, defined as at least a 30% reduction in weekly worst abdominal pain and an increase of at least one complete spontaneous bowel movement from baseline for at least 6 of 12 weeks.
- Overall Responder Rate: 44% of patients taking INCB123667 met the primary endpoint, compared to 33% of patients on placebo.
- Complete Spontaneous Bowel Movement (CSBM) Response: 41% of patients on INCB123667 experienced an increase of at least one CSBM from baseline for at least 9 of 12 weeks, compared to 26% of patients on placebo.
- Abdominal Pain Response: 48% of patients taking INCB123667 achieved at least a 30% reduction in weekly worst abdominal pain from baseline for at least 9 of 12 weeks, compared to 37% of patients on placebo.
- IBS-C Symptom Severity: Patients treated with INCB123667 showed a mean reduction of 105.3 points in their IBS-C Symptom Severity Score (IBS-SSS) at Week 12, indicating an improvement in symptoms. Patients on placebo had a mean reduction of 78.9 points.
Results in Hyperphosphatemia in Dialysis Patients
An open-label Phase 2 study (NCT04746682) investigated INCB123667 in 10 patients with hyperphosphatemia who were undergoing dialysis. The primary objective was to evaluate the change in serum phosphate levels from baseline to Week 4.
- Serum Phosphate Reduction: Patients treated with INCB123667 experienced a mean reduction in serum phosphate of 2.1 mg/dL by Week 4. Their average serum phosphate level decreased from 6.7 mg/dL at baseline to 4.6 mg/dL. A reduction in serum phosphate indicates an improvement.
- Achieving Target Phosphate Levels: 80% of patients (8 out of 10) achieved the target serum phosphate level of less than 5.5 mg/dL at Week 4.
Currently Recruiting Trials
INCB123667 is currently being investigated in several clinical trials, exploring its potential in different health conditions and participant groups. These studies aim to gather more information about how the drug works, its safety, and its effectiveness.
One significant trial, NCT07214779, is a Phase 3 study sponsored by Incyte Corporation. This trial is evaluating INCB123667 versus an investigator's choice of chemotherapy in participants with platinum-resistant ovarian cancer who have cyclin E1 overexpression. The study aims to enroll approximately 466 participants, divided into Treatment Group A (TGA) and Treatment Group B (TGB), to compare the outcomes of INCB123667 with standard treatment.
Another study, NCT07023627, is a Phase 2 trial, also sponsored by Incyte Corporation. This study focuses on assessing the safety and efficacy of INCB123667 specifically in participants with platinum-resistant ovarian cancer and cyclin E1 overexpression. It plans to include around 160 participants across Cohort 1, Cohort 2, and Cohort 3, further exploring the drug's role in this specific patient population.
Additionally, a Phase 1 study, NCT06909162, is underway to understand the foundational properties of INCB123667. This trial, sponsored by Incyte Corporation, is designed to evaluate how food affects the single-dose pharmacokinetics of INCB123667 and to assess potential drug-drug interactions with itraconazole and carbamazepine. This study involves healthy adult participants, with an enrollment target of 51 individuals across various treatment cohorts, including INCB123667 administered fasted or fed, and in combination with itraconazole or carbamazepine.
Where to Participate
Clinical trials for INCB123667 are currently recruiting across a wide geographic area, making participation accessible to many individuals. These studies are being conducted at 70 sites located in 64 cities across 38 states.
Some of the top locations with multiple sites or active recruitment include:
- St Louis, Missouri
- Ann Arbor, Michigan
- Los Angeles, California
- Billings, Montana
- Winston-Salem, North Carolina
- Fairfax, Virginia
- Charlotte, North Carolina
- Aurora, Colorado
- San Diego, California
- Little Rock, Arkansas
Eligibility criteria for these trials generally include participants aged 18 to 99 years, of all genders. Some studies are specifically designed for healthy adult volunteers, while others focus on individuals with specific medical conditions. Children are not eligible to participate in these particular trials.
Development Timeline
The journey of INCB123667 in clinical development began on April 3, 2025, with its first clinical trial. Since then, Incyte Corporation has been the sole sponsor, driving the research and development of this investigational drug.
To date, a total of 6 clinical trials for INCB123667 have been initiated, aiming to enroll 718 participants across various studies. The development program has progressed through different phases, starting with four Phase 1 trials to establish foundational safety and pharmacokinetic data. Following these initial studies, the program advanced to include one Phase 2 trial and one Phase 3 trial, indicating a steady progression in evaluating the drug's potential.
The scope of INCB123667's investigation has also expanded over time. Initially, studies focused on conditions such as Irritable Bowel Syndrome with Constipation (IBS-C) and hyperphosphatemia. The development pipeline later broadened to explore its effects in participants with Hepatic Insufficiency, Liver Diseases, and Renal Impairment, reflecting an evolving understanding of the drug's potential applications. The latest trial is projected to conclude by April 30, 2026.