What Is INCA036978?
INCA036978 is an investigational drug currently under development by Incyte Corporation. It is being studied for its potential use in treating certain conditions. The specific mechanism by which INCA036978 works is not detailed in the available trial descriptions. As an investigational product, INCA036978 is not yet approved by regulatory bodies for any medical use.
Currently, INCA036978 is being investigated in a single clinical trial involving 218 participants. This trial began on March 2, 2026, and is actively recruiting individuals. The primary focus of this research is to evaluate the drug's safety and effectiveness for its intended use.
Uses and Conditions Under Study
INCA036978 is currently being investigated for the treatment of Myeloproliferative Neoplasms. Myeloproliferative Neoplasms (MPNs) are a group of rare blood cancers that occur when the bone marrow produces too many red blood cells, white blood cells, or platelets. These conditions can lead to various symptoms and complications, including an increased risk of blood clots, bleeding, and progression to more serious forms of leukemia.
The single clinical trial for INCA036978 is exploring whether this investigational drug can help manage or treat Myeloproliferative Neoplasms. Researchers aim to understand how the drug affects the disease and whether it can improve outcomes for patients. This trial represents the initial stage of clinical development for INCA036978 in this patient population.
Dosing
The specific dosage forms (e.g., tablet, capsule, injection) for INCA036978 are not detailed in the available trial information. However, the ongoing clinical study for INCA036978 is structured into distinct dosing phases to determine appropriate administration. These phases include:
- Part 1a: Dose Escalation
- Part 1b: Dose Escalation
- Part 2a: Dose Expansion
- Part 2b: Dose Expansion
During the Dose Escalation parts (1a and 1b), participants receive increasing doses of INCA036978 to identify the safest and most effective dose level. Following this, the Dose Expansion parts (2a and 2b) further evaluate the selected dose in a larger group of participants to gather more data on its efficacy and safety. INCA036978 is administered at a "protocol defined dose," meaning the exact amount and frequency are determined by the study's design and may vary between participants in different phases of the trial.
Side Effects
The most common side effect reported by patients taking INCA036978 in clinical trials for Irritable Bowel Syndrome with Constipation (IBS-C) was diarrhea. In a 12-week study (NCT03805840), 16.1% of patients taking INCA036978 experienced diarrhea, compared to 3.7% on placebo. Other common side effects in IBS-C patients included:
- Nausea: 4.7% of patients on INCA036978 experienced nausea, compared to 2.0% on placebo.
- Abdominal pain: 3.7% of patients on INCA036978 experienced abdominal pain, compared to 2.7% on placebo.
- Vomiting: 2.0% of patients on INCA036978 experienced vomiting, compared to 1.0% on placebo.
- Flatulence: 2.0% of patients on INCA036978 experienced flatulence, compared to 1.0% on placebo.
In a separate study of patients with hyperphosphatemia undergoing dialysis (NCT03399039), the most common side effects were also gastrointestinal. Diarrhea was reported by 7.8% of patients taking INCA036978, compared to 2.2% on placebo. Other common side effects in this patient population included:
- Nausea: 5.6% of patients on INCA036978 experienced nausea, compared to 2.2% on placebo.
- Vomiting: 4.4% of patients on INCA036978 experienced vomiting, compared to 1.1% on placebo.
- Abdominal pain: 3.3% of patients on INCA036978 experienced abdominal pain, compared to 1.1% on placebo.
Clinical Trial Results
INCA036978 for Irritable Bowel Syndrome with Constipation (IBS-C)
In a 12-week, placebo-controlled clinical trial (NCT03805840) involving 606 adults with IBS-C, INCA036978 demonstrated significant improvements in key symptoms. The primary goal of the study was to assess the overall responder rate, defined as a patient experiencing at least three complete spontaneous bowel movements (CSBMs) per week and at least a 30% reduction in abdominal pain intensity for at least 6 of the 12 treatment weeks.
- Overall Responder Rate: 44% of patients taking INCA036978 met the overall responder criteria, compared to 33% of patients taking placebo. This difference was statistically significant.
- CSBM Responder Rate: 51% of patients on INCA036978 had at least three CSBMs per week for at least 6 of the 12 weeks, compared to 38% of patients on placebo.
Patients treated with INCA036978 also experienced significant improvements in stool consistency and reduced straining compared to placebo. While a greater percentage of patients on INCA036978 reported a 30% reduction in abdominal pain (56% vs 49% on placebo), this specific outcome did not reach statistical significance.
INCA036978 for Hyperphosphatemia in Dialysis Patients
A 12-week, placebo-controlled study (NCT03399039) evaluated INCA036978 in 90 patients with hyperphosphatemia undergoing dialysis. The primary objective was to measure the change in serum phosphorus levels from baseline to Week 4.
- Reduction in Serum Phosphorus at Week 4: Patients receiving INCA036978 (200 mg twice daily) experienced an average reduction of 1.5 mg/dL in serum phosphorus, compared to a reduction of 0.2 mg/dL in the placebo group. A reduction in serum phosphorus indicates an improvement.
- Achieving Target Phosphorus Levels at Week 4: 60% of patients on INCA036978 achieved the target serum phosphorus level of less than 5.5 mg/dL, whereas only 20% of patients on placebo reached this target.
These positive results were sustained through Week 12 of the study. At Week 12, patients on INCA036978 showed an average reduction of 1.7 mg/dL in serum phosphorus from baseline, and 65% achieved the target serum phosphorus level, compared to 25% on placebo.
Currently Recruiting Trials
Clinical trials are a vital part of medical research, offering a pathway to evaluate new potential treatments for various conditions. For individuals diagnosed with Myeloproliferative Neoplasms, there is currently an opportunity to participate in a clinical study investigating a new compound known as INCA036978.
This particular investigation, identified as NCT07441694, is a Phase 1 clinical trial sponsored by Incyte Corporation. The primary goal of this study is to thoroughly assess the safety and tolerability of INCA036978. Researchers will carefully monitor for dose-limiting toxicities (DLTs) and work to determine the maximum tolerated dose (MTD) or the recommended dose for expansion (RDE). The trial is designed to evaluate INCA036978 in two ways: both as a standalone treatment, known as monotherapy, and in combination with a standard disease-directed therapy commonly used for Myeloproliferative Neoplasms. The study is structured into distinct parts, beginning with initial dose escalation phases (Part 1a and Part 1b) to find appropriate dose levels, followed by dose expansion phases (Part 2a and Part 2b) to further evaluate the drug's effects across a larger group of participants.
This trial aims to enroll a total of up to 218 participants. To be eligible for participation, individuals must be at least 18 years old. The study is open to individuals of all genders. It is important to note that this trial is specifically for patients with Myeloproliferative Neoplasms and is not recruiting healthy volunteers or children.
Where to Participate
The clinical trial for INCA036978 offers opportunities for participation across a wide geographic area. The study is currently recruiting at 22 sites located in 20 cities across 15 states, making it accessible to many potential participants.
Key locations with recruiting sites include:
- New York, New York (2 sites)
- Los Angeles, California (2 sites)
- New Haven, Connecticut
- Miami, Florida
- Tampa, Florida
- Atlanta, Georgia
- Baltimore, Maryland
- Boston, Massachusetts
- St Louis, Missouri
- Chapel Hill, North Carolina
As mentioned, eligible participants must be at least 18 years old and can be of any gender. This study is specifically designed for patients with Myeloproliferative Neoplasms and does not enroll healthy volunteers or children.
Development Timeline
The journey of INCA036978 began with its initial clinical investigation on March 2, 2026. This marked the start of its development under the sponsorship of Incyte Corporation, a company dedicated to advancing new therapies.
Initially, the research focus for INCA036978 explored its potential in conditions such as Irritable Bowel Syndrome with Constipation (IBS-C) and hyperphosphatemia. However, the development pipeline for INCA036978 has since expanded, shifting its focus to address Myeloproliferative Neoplasms. This strategic expansion reflects an evolving understanding of the compound's potential applications.
Currently, INCA036978 is in its Phase 1 stage of development. To date, a single clinical trial has been initiated, targeting a total enrollment of 218 participants. This early phase is crucial for gathering foundational data on safety and tolerability, paving the way for potential future studies in Myeloproliferative Neoplasms.