Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Apraglutide · 7 trials · 4 indications
System organ class, frequency and severity
Clinical Chemistry panel of analytes will be examined for clinically significant changes.
Hematology panel of analytes will be examined for clinically significant changes.
Hemostasis INR will be examined for clinically significant changes.
Urinanalysis panel of analytes will be examined for clinically significant changes.
* Systolic and diastolic blood pressure in mmHg will be examined for clinically significant changes. * Heart rate in Beats per Minute (BPM) will be examined for clinically significant changes.
ECG; intervals and rhythm
A TEAE was any unfavorable and unintended sign, symptom, or disease temporally associated with apraglutide, whether or not related, that occurred or worsened after the dose of apraglutide. A serious TEAE was defined as any TEAE that resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect or was an important medical event. Clinically significant changes from baseline in clinical chemistry, hematology, hemostasis, anti-drug antibodies (ADAs), and urine analysis were reported as adverse events. Adverse events of special interest (AESI) included injection site reaction, gastrointestinal obstruction, gallbladder, biliary, and pancreatic disease, fluid overload, colorectal polyps, malignancies.
Applicable to Protocol V3.0 implemented in France (classed as secondary endpoint in Protocol V4.0 \[implemented in Belgium\]). The absorption was defined as dietary intake minus output from fecal excretion over a 72-hour MB period at a given analysis time point. Since dietary intake and fecal excretion were measured daily, i.e., up to three measurements may contribute to absorption calculations, the average over all available daily absorption measurements over the 72-hour period were used for analysis.
Apraglutide was quantified in human plasma samples using a fully validated liquid chromatography mass spectrometry-based method, with a lower limit of quantification (LLOQ) of 1 ng/mL and an upper limit of 200 ng/mL. Plasma pharmacokinetic (PK) parameters for apraglutide were estimated using non-compartmental methods from the concentration-time profiles. Actual sampling times, rather than scheduled sampling times, were used. AUCinf was calculated as: AUCinf = AUC from time zero to the last quantifiable concentration (AUClast) + (Clast/kel) where Clast was the observed concentration at the last time point with concentrations above the lower limit of quantification and kel was the terminal elimination rate constant.
Apraglutide was quantified in human plasma samples using a fully validated liquid chromatography mass spectrometry-based method, with a LLOQ of 1 ng/mL and an upper limit of 200 ng/mL. Plasma PK parameters for apraglutide were estimated using non-compartmental methods from the concentration-time profiles. Actual sampling times, rather than scheduled sampling times, were used.
Apraglutide was quantified in human plasma samples using a fully validated liquid chromatography mass spectrometry-based method, with a LLOQ of 1 ng/mL and an upper limit of 200 ng/mL. Plasma PK parameters for apraglutide were estimated using non-compartmental methods from the concentration-time profiles. Actual sampling times, rather than scheduled sampling times, were used. Cmax was the observed peak analyte concentration obtained directly from the experimental data without interpolation, expressed in concentration units.
Pharmacokinetic (PK) samples collected for the measurement of plasma concentration of apraglutide were analyzed using a validated analytical method in compliance with applicable standard operating procedures.
PK samples collected for the measurement of plasma concentration of apraglutide were analyzed using a validated analytical method in compliance with applicable standard operating procedures.
| Arm | Type | Description |
|---|---|---|
| Apraglutide subcutaneous (SC) injections, once weekly | EXPERIMENTAL | Peptide analogue of Glucagon-like Peptide 2 (GLP-2) |
| Apraglutide SC injections, once weekly | EXPERIMENTAL | Peptide analogue of GLP-2 |
| Placebo | PLACEBO_COMPARATOR | Placebo for apraglutide, SC injection once weekly |
| Apraglutide | EXPERIMENTAL | All participants received apraglutide administered subcutaneously (SC) once weekly for 52 weeks. |
| Single SC dose of 5 mg from DCS | EXPERIMENTAL | - |
| Two concomitant single SC doses of 2.5 mg from DCS | EXPERIMENTAL | - |
| Single SC dose of 5 mg from vial | ACTIVE_COMPARATOR | - |
| Apraglutide SC injections | EXPERIMENTAL | - |
| Part 1: Moderate hepatic impairment | EXPERIMENTAL | Child-Pugh B |
| Part 1: Normal hepatic function | EXPERIMENTAL | - |
| Part 2: Mild hepatic impairment | EXPERIMENTAL | Child-Pugh A |
| Severe Renal Impairment | EXPERIMENTAL | eGFR (mL/min/1.73 m2): \<30 not on hemodialysis |
| Normal Healthy Match | EXPERIMENTAL | eGFR (mL/min/1.73 m2): ≥90 |
| Moderate Renal Impairment | EXPERIMENTAL | eGFR (mL/min/1.73 m2): ≥30 to 60 |
| Mild Renal Impairment | EXPERIMENTAL | eGFR (mL/min/1.73 m2): ≥60 to 90 |
| Name | Type | Description |
|---|---|---|
| Apraglutide | DRUG | Apraglutide is a synthetic peptide analogue of GLP-2 under development for treatment of SBS-IF, which acts as a full agonist at the GLP-2 receptor with in vitro potency and selectivity comparable with native GLP-2 |
| Placebo | DRUG | Matching placebo to apraglutide |
| Acetaminophen | DRUG | Acetaminophen mixed with a liquid meal |
Inclusion Criteria: 1. Males and females with a diagnosis of SBS-IF secondary to surgical resection of the small intestine, with Colon-in-Continuity (CIC) or stoma, who were trial subjects of parent trials TA799-007 or TA799-013 2. Able to give informed consent and agree to follow the details of pa...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Takeda Pharmaceutical Co. Ltd. Sponsored ADR | TAK | 5 | PHASE3 | Teduglutide |
| Jaguar Health, Inc. | JAGX | 1 | PHASE2 | Crofelemer for |
| Smith & Nephew plc Sponsored ADR | SNN | 1 | - | Undisclosed |
Apraglutide is an investigational peptide being studied for Short Bowel Syndrome, a condition where the intestine cannot absorb enough nutrients. It is also being evaluated in clinical trials involving healthy subjects, Hepatic Impairment, and Chronic Kidney Disease. The drug is in clinical development and has not been approved by the FDA.
Apraglutide is a peptide-based drug, classified under the -tide (peptide) target class. It is being studied for its effects in Short Bowel Syndrome and other conditions. The specific molecular target is not disclosed in the available information.
Apraglutide is being developed by Ironwood Pharmaceuticals, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol IRWD. The company is conducting clinical trials to evaluate the drug's safety and efficacy in various patient populations.
Apraglutide is in Phase 3 clinical development for Short Bowel Syndrome, with an active open-label extension trial. It has also completed Phase 1 studies in Chronic Kidney Disease and Hepatic Impairment, and a Phase 2 study in Short Bowel Syndrome. The drug is investigational and not yet approved.
Apraglutide has been studied in several clinical trials, including NCT04699032 (Phase 1, Chronic Kidney Disease), NCT04964986 (Phase 2, Short Bowel Syndrome), NCT05018286 (Phase 3, Short Bowel Syndrome, active), and NCT05706623 (Phase 1, Hepatic Impairment). These trials assess pharmacokinetics, safety, and long-term outcomes.
Apraglutide is a distinct investigational peptide drug developed by Ironwood Pharmaceuticals. No alternative names for Apraglutide have been reported in the available clinical trial information. It is being studied under its own name across multiple trials for Short Bowel Syndrome and other conditions.