Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Encapsulated Mesalamine Granules (eMG)
Encapsulated Mesalamine Granules · 1 trial · 1 indication
An AE was defined as any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A TEAE was defined as any event with a start date occurring on or after treatment Day 1 or, if pre-existing, worsening after treatment Day 1. Serious AEs were defined as death, a life-threatening AE, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, or an important medical event that jeopardized participant and required medical intervention to prevent 1 of the outcomes listed in this definition. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section.
Number of participants who prematurely discontinued treatment due to any reason were reported.
Criteria for potentially clinically significant abnormal hematology and blood chemistry values included: hemoglobin (grams/deciliter \[g/dL\]): \<10 and ≥3 decrease, or \>20; hematocrit (%): \<30 and ≥10 decrease, or \>60; platelets (\*10\^9 cells/liter): \<100 or \>700 (normal: 150-400); white blood cells (\*10\^9 cells/liter): \<2.3 or \>16.2 (normal: 3.5-11.1); alanine aminotransferase (units/liter \[U/L\]): ≥3 \* upper limit of normal (ULN) (normal range 0-47 U/L); aspartate aminotransferase (U/L): ≥3 \* ULN (normal range 0-37 U/L); total bilirubin (micromoles/liter \[µmol/L\]): \>2 times; and calcium creatinine clearance (milliliters/minute \[mL/min\]): ≤50.
Vital signs included systolic and diastolic blood pressure, pulse rate, body temperature, or body weight.
| Arm | Type | Description |
|---|---|---|
| Encapsulated Mesalamine Granules (eMG) | EXPERIMENTAL | Participants will receive eMG 1.5 grams (4 capsules of eMG 0.375 grams each) QD orally in the morning for up to 24 months. |
| Name | Type | Description |
|---|---|---|
| Encapsulated Mesalamine Granules (eMG) | DRUG | eMG capsules will be administered per dose and schedule specified in the arm. |
Inclusion Criteria: 1. An Institutional Review Board (IRB)/Ethics Committee (EC) approved informed consent is signed and dated prior to any study-related activities. 2. Participant has successfully participated in a previous MP clinical study per investigator's discretion with successful participat...
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Encapsulated Mesalamine Granules is an investigational small molecule therapy being developed for ulcerative colitis, a form of inflammatory bowel disease. It is specifically being studied for maintaining remission in adults with ulcerative colitis. The drug is not yet approved for any indication and remains in clinical development.
Encapsulated Mesalamine Granules is being developed by Bausch Health Companies Inc., which trades on the New York Stock Exchange under the ticker symbol BHC. The company is responsible for the clinical program evaluating this therapy in ulcerative colitis.
Encapsulated Mesalamine Granules is in Phase 3 clinical development. The program includes one completed Phase 3 trial. The drug is investigational and has not been approved by the FDA or any other regulatory agency for the treatment of ulcerative colitis.
Encapsulated Mesalamine Granules has been evaluated in one Phase 3 clinical trial, NCT00326209, titled Long-Term Safety and Tolerability of Mesalamine Pellets in Participants With Ulcerative Colitis in Remission. The trial enrolled 393 participants in the United States and has been completed.
Yes, Encapsulated Mesalamine Granules is also known as eMG. Both names refer to the same investigational therapy being developed by Bausch Health Companies Inc. for ulcerative colitis. The abbreviation eMG is commonly used in reference to this drug candidate.