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- ||| glepaglutide (ZP1848) / Zealand Pharma
P3 data, Journal: Glepaglutide, a Long-acting Glucagon-like Peptide-2 Analog, Reduces Parenteral Support in Patients with Short Bowel Syndrome: a Phase 3, Randomized, Controlled Trial. (Pubmed Central) - Mar 23, 2025
P3
Glepaglutide treatment in patients with SBS with intestinal failure resulted in clinically relevant reductions in PS requirements and was well tolerated. (ClinicalTrials.gov, Number: NCT03690206; ClinicalTrialsRegister.eu, Number: 2017-004394-14.).
- | glepaglutide (ZP1848) / Zealand Pharma
Journal: Glepaglutide-Loaded Foam for the Induction of Mucosal Healing in the Treatment of Inflammatory Bowel Disease. (Pubmed Central) - Mar 17, 2025
(ClinicalTrials.gov, Number: NCT03690206; ClinicalTrialsRegister.eu, Number: 2017-004394-14.). The foam formulation improved macromolecule absorption in the colon, with fast recovery of enhanced permeation that dissipated after 4
- | Gattex (teduglutide) / Takeda, apraglutide (FE 203799) / Ironwood Pharma, glepaglutide (ZP1848) / Zealand Pharma
Journal: Use of glucagon-like polypeptide 2 analogs for intestinal failure. (Pubmed Central) - Dec 17, 2024
More recently, ultralong acting GLP-2 analogs with half-lives of 70-80?hours can improve gastrointestinal function in surgically foreshortened bowel with only one injection every three to seven days. Future research is likely to focus upon the potential complementary role of GLP-1 and GLP-2 in treating short bowel syndrome.
- || Review, Journal: Emerging drugs for the treatment of short bowel syndrome. (Pubmed Central) - Sep 26, 2024
Future research is likely to focus upon the potential complementary role of GLP-1 and GLP-2 in treating short bowel syndrome. Clinical trials and real-world experience demonstrated that Teduglutide
- |||| glepaglutide (ZP1848) / Zealand Pharma
Enrollment closed, Trial completion date, Trial primary completion date: EASE SBS 2: Evaluation of Long Term Safety and Efficacy of Glepaglutide in Treatment of SBS (clinicaltrials.gov) - Sep 20, 2024
P3, N=145, Active, not recruiting, Sponsor: Zealand Pharma
Clinical trials and real-world experience demonstrated that Teduglutide Recruiting --> Active, not recruiting | Trial completion date: Dec 2024 --> Oct 2026 | Trial primary completion date: Dec 2024 --> Oct 2026
- glepaglutide (ZP1848) / Zealand Pharma
GLEPAGLUTIDE REDUCES NEED OF PARENTERAL SUPPORT OF FLUIDS, ELECTROLYTES, ENERGY AND MACRONUTRIENTS IN SHORT BOWEL SYNDROME PATIENTS: RESULTS FROM THE 52-WEEK OPEN-LABEL EASE SBS-4 STUDY (Lehar 1) - Jul 18, 2024 - Abstract #UEGW2024UEGW_2813;
Glepaglutide induced clinically meaningful, sustained reduction in the PS need, including fluids, electrolytes, energy and macronutrients at 52 weeks in SBS patients with and without CIC. These data are in alignment with glepaglutide-induced increases in intestinal absorptive capacity as demonstrated in state-of-art metabolic balance studies.
- || Gattex (teduglutide) / Takeda, apraglutide (FE 203799) / Ironwood Pharma, glepaglutide (ZP1848) / Zealand Pharma
Retrospective data, Review, Journal: Efficacy and safety of glucagon-like peptide-2 (GLP-2) in patients with short bowel syndrome; A Systematic Review and Network Meta-analysis. (Pubmed Central) - Jul 4, 2024
Despite the small number of patients in the included studies and variable follow-up duration, GLP-2 seems to be safe and effective in patients with SBS. GLP-2 showed a positive effect on increasing plasma citrulline level and decreasing ALP level.
- | Gattex (teduglutide) / Takeda, apraglutide (FE 203799) / Ironwood Pharma, glepaglutide (ZP1848) / Zealand Pharma
Journal: Intestinal adaptation and rehabilitation in adults with short bowel syndrome. (Pubmed Central) - Jul 4, 2024
Some case reports highlighted the potential benefit of treatment with teduglutide in non-SBS gastrointestinal diseases, such as graft-versus-host disease, primary amyloidosis and refractory microscopic colitis. Phase 2 RCTs on safety and efficacy of two new long-acting GLP-2 analogues, glepaglutide and apraglutide, were published, and phase 3 RCTs have been completed.
- glepaglutide (ZP1848) / Zealand Pharma
EFFECT OF GLEPAGLUTIDE, A LONG-ACTING GLP-2 ANALOG, ON HEPATIC, RENAL AND BONE MARKERS IN PATIENTS WITH SHORT BOWEL SYNDROME: RESULTS OF EASE SBS-1 PHASE 3 TRIAL (Hall A, Poster Hall - Walter E. Washington Convention Center) - Mar 14, 2024 - Abstract #DDW2024DDW_7911;
In addition to clinically relevant reductions in PS requirements, short-term treatment (24 weeks) of SBS-IF patients with the long-acting GLP-2 analog glepaglutide also led to improvement in liver function tests, with no short-term change in renal function or bone markers. It is possible that longer-term monitoring is required to show additional changes, and these outcomes are pending.
- ||| glepaglutide (ZP1848) / Zealand Pharma
Trial completion date, Trial primary completion date: EASE SBS 3: Evaluation of Long Term Safety and Efficacy of Glepaglutide in Treatment of SBS - Extension Trial (clinicaltrials.gov) - Dec 30, 2023
P3, N=129, Enrolling by invitation, Sponsor: Zealand Pharma
- || glepaglutide (ZP1848) / Zealand Pharma
Trial completion: EASE SBS 4: The Long-term Effect on Intestinal Absorption and Safety of Treatment With Glepaglutide in Patients With Short Bowel Syndrome (clinicaltrials.gov) - Sep 30, 2023
P3b, N=12, Completed, Sponsor: Zealand Pharma
It is possible that longer-term monitoring is required to show additional changes, and these outcomes are pending. Active, not recruiting --> Completed
- glepaglutide (ZP1848) / Zealand Pharma
EARLY RESPONSE TO GLEPAGLUTIDE, A NOVEL LONG-ACTING GLP-2 ANALOG, IN SHORT BOWEL SYNDROME PATIENTS WITH INTESTINAL FAILURE: RESULTS OF 24-WEEK PHASE 3 TRIAL (Auditorium 12) - Jul 8, 2023 - Abstract #UEGW2023UEGW_1032;
- | glepaglutide (ZP1848) / Zealand Pharma
Journal: Differential Responses of the GLP-1 and GLP-2 Receptors to N-Terminal Modification of a Dual Agonist. (Pubmed Central) - Jun 8, 2023
Using variants of the hormone GLP-2 and the designed clinical agonist glepaglutide (GLE), we find that the GLP-2R is quite tolerant of variations in ?-helical propensity near the agonist N-terminus, which contrasts with signaling at the GLP-1R...This comparison supports the conclusion that the GLP-1R and GLP-2R differ in their response to variations in helical propensity near the agonist N-terminus. The data offer a basis for development of new hormone analogues with distinctive and potentially useful activity profiles; for example, one of the GLE analogues is a potent agonist of the GLP-2R but also a potent antagonist of the GLP-1R, a novel form of polypharmacology.
- HM15912 / Hanmi
Beneficial Effect on Intestinal Growth of a Long-Acting GLP-2 Analog, HM15912, after Treatment Switching from Conventional GLP-2 Drug or Other Long-Acting GLP-2 Analogs under Clinical Development in Animal Model (ENDOExpo) - May 11, 2023 - Abstract #ENDO2023ENDO_1526;
The widespread use of teduglutide, which is only approved GLP-2 analog drug for short bowel syndrome (SBS), may be still limited due to insufficient efficacy and leading to a significant burden for patients by daily administration...Next, we synthesized GLP-2 analogs to have same sequences with glepaglutide and apraglutide...As a results, HM15912 significantly promoted small intestinal growth than existing GLP-2 analogs even with a less frequent dosing interval of once a week in rodents. A phase 2 clinical study of once-monthly dosing in patients with SBS is ongoing to evaluate the clinical relevance of these findings.
- | glepaglutide (ZP1848) / Zealand Pharma
Preclinical, Journal: Glepaglutide, a novel glucagon-like peptide-2 agonist, has anti-inflammatory and mucosal regenerative effects in an experimental model of inflammatory bowel disease in rats. (Pubmed Central) - Mar 25, 2023
Glepaglutide has anti-inflammatory and intestinotrophic effects without the need for pre-treatment in a rat model of small intestinal inflammation. Thus, glepaglutide is of potential clinical interest for patients with IBD.
- glepaglutide (ZP1848) / Zealand Pharma
GLEPAGLUTIDE, A LONG-ACTING GLP-2 ANALOG, SIGNIFICANTLY REDUCES NEED FOR PARENTERAL SUPPORT IN PATIENTS WITH SHORT BOWEL SYNDROME: RESULTS OF EASE SBS-1, A RANDOMIZED, DOUBLE-BLIND, 24-WEEK PHASE 3 TRIAL (S102 - McCormick Place) - Mar 23, 2023 - Abstract #DDW2023DDW_5226;
Treatment with the novel, long-acting GLP-2 analog glepaglutide resulted in significant and clinically relevant reductions in PS requirements for SBS patients with intestinal failure. One in seven patients treated with glepaglutide TW achieved enteral autonomy.
- || glepaglutide (ZP1848) / Zealand Pharma
PK/PD data, Journal: Pharmacokinetics, Safety, and Tolerability of Glepaglutide, a Long-Acting GLP-2 Analog, in Subjects with Renal Impairment. (Pubmed Central) - Feb 22, 2023
P1
No difference in glepaglutide pharmacokinetics was seen between renal impaired and normal subjects. Based on this trial, dose adjustment appears not to be warranted in SBS patients with renal impairment.
- ||| glepaglutide (ZP1848) / Zealand Pharma
Trial completion date, Trial primary completion date: EASE SBS 2: Evaluation of Long Term Safety and Efficacy of Glepaglutide in Treatment of SBS (clinicaltrials.gov) - Feb 6, 2023
P3, N=145, Recruiting, Sponsor: Zealand Pharma
Based on this trial, dose adjustment appears not to be warranted in SBS patients with renal impairment. Trial completion date: Nov 2022 --> Dec 2024 | Trial primary completion date: Nov 2022 --> Dec 2024
- || Gattex (teduglutide) / Takeda, apraglutide (FE 203799) / VectivBio, Asahi Kasei, glepaglutide (ZP1848) / Zealand Pharma
Review, Journal: Glucagon-like peptide-2 analogues for Crohn's disease patients with short bowel syndrome and intestinal failure. (Pubmed Central) - Dec 13, 2022
Teduglutide has been approved for the treatment of SBS-IF, and apraglutide is currently in clinical development. The use of these drugs was examined with a focus on their use in CD patients.
- || glepaglutide (ZP1848) / Zealand Pharma
PK/PD data, Journal: Pharmacokinetics of Glepaglutide, A Long-Acting Glucagon-Like Peptide-2 Analogue: A Study in Healthy Subjects. (Pubmed Central) - Nov 4, 2022
P1
Slow release of active metabolites following subcutaneous dosing leads to a significantly protracted pharmacokinetic profile for glepaglutide. These results support that once- or twice-weekly subcutaneous dosing of glepaglutide could be an efficacious therapy for intestinal rehabilitation.
- ||||| glepaglutide (ZP1848) / Zealand Pharma
Trial completion: EASE SBS 1: Efficacy And Safety Evaluation of Glepaglutide in Treatment of Short Bowel Syndrome (SBS) (clinicaltrials.gov) - Oct 31, 2022
P3, N=106, Completed, Sponsor: Zealand Pharma
These results support that once- or twice-weekly subcutaneous dosing of glepaglutide could be an efficacious therapy for intestinal rehabilitation. Active, not recruiting --> Completed
- || glepaglutide (ZP1848) / Zealand Pharma
P3 data: $ZEAL: Glepaglutide phase 3 data in SBS - Q3'22 Conferences #BioPharmAmerica: 28-29 Sep #HFSA2022 : 30 Sep - 3 Oct #AAO: 30 Sep - 3 Oct Roadshows Analyst roadshow: Paris - 27 Sep (2/2) (Twitter) - Sep 25, 2022
- || glepaglutide (ZP1848) / Zealand Pharma
$ZEAL: Glepaglutide ph3 data in SBS - Q3'22 Conferences #ESMO2022 - 9-13 Sep #MDSCongress - 15-18 Sep #EHDN - 16-18 Sep Roadshows $ZEAL: NY - 13 Sep $LVTX: Zurich, Stockholm - 14-15 Sep $CALTX: Virtual (US) - 15-16 Sep $TRVX: Virtual - 16 Sep (2/2) (Twitter) - Sep 11, 2022
- || glepaglutide (ZP1848) / Zealand Pharma
Enrollment closed: EASE SBS 4: The Long-term Effect on Intestinal Absorption and Safety of Treatment With Glepaglutide in Patients With Short Bowel Syndrome (clinicaltrials.gov) - Aug 23, 2022
P3b, N=12, Active, not recruiting, Sponsor: Zealand Pharma
Active, not recruiting --> Completed Recruiting --> Active, not recruiting
- || Gattex (teduglutide) / Takeda, apraglutide (FE 203799) / VectivBio, Asahi Kasei, glepaglutide (ZP1848) / Zealand Pharma
Review, Journal: Therapeutic Potential of GLP-2 Analogs in Gastrointestinal Disorders: Current Knowledge, Nutritional Aspects, and Future Perspectives. (Pubmed Central) - Aug 7, 2022
Another two longer-acting analogs, glepaglutide and apraglutide, are currently undergoing phase III clinical trials. The use of GLP-2 analogs is effective in the management of SBS-IF and may show promise in the treatment of other severe gastrointestinal disorders associated with loss of effective intestinal resorptive surface area.
- || glepaglutide (ZP1848) / Zealand Pharma
Clinical, P2 data, Journal: Bile acid - farnesoid X receptor - fibroblast growth factor 19 axis in patients with short bowel syndrome: the randomized glepaglutide phase 2 trial. (Pubmed Central) - May 29, 2022
Glepaglutide may stimulate the bile acid/FXR/FGF19 axis, leading to increased plasma concentrations of FGF19. Thereby, glepaglutide may ameliorate the accelerated de novo bile acid synthesis and play a role in the prevention and/or treatment of intestinal failure-associated liver disease.
- | glepaglutide (ZP1848) / Zealand Pharma
Journal: Short- versus long-term, gender and species differences in the intestinotrophic effects of long-acting glucagon-like peptide 2 analog. (Pubmed Central) - May 29, 2022
The findings were still present following a 6-week recovery period, indicating long-acting intestinotrophic effects of glepaglutide. These studies demonstrate that a long-acting GLP-2 analogue (glepaglutide) has a fast onset and long duration of intestinotrophic action with similar profile in both genders and species (rat and dog).
- || glepaglutide (ZP1848) / Zealand Pharma
P2 data, Journal: Effects of glepaglutide, a long-acting glucagon-like peptide-2 analog, on intestinal morphology and perfusion in patients with short bowel syndrome: Findings from a randomized phase 2 trial. (Pubmed Central) - May 6, 2022
The increase in plasma citrulline and the morphological improvements may partly account for improvement in the intestinal absorptive function. However, the finding of a stability in perfusion after three weeks of treatment with glepaglutide may have been preceded by a more profound acute-phase increase in intestinal perfusion at treatment initiation.
- | Gattex (teduglutide) / Takeda, apraglutide (FE 203799) / VectivBio, Asahi Kasei, glepaglutide (ZP1848) / Zealand Pharma
Journal: An updated overview of glucagon-like peptide-2 analog trophic therapy for short bowel syndrome in adults. (Pubmed Central) - Apr 5, 2022
Many high-quality studies have provided evidence-based medical findings to support the development of clinical guidelines. This article reviews the latest research advancements regarding the use of glucagon-like peptide-2 analogs (teduglutide, glepaglutide, and apraglutide) in the treatment of SBS.
- |||| glepaglutide (ZP1848) / Zealand Pharma
Enrollment closed: EASE SBS 1: Efficacy And Safety Evaluation of Glepaglutide in Treatment of Short Bowel Syndrome (SBS) (clinicaltrials.gov) - Feb 25, 2022
P3, N=129, Active, not recruiting, Sponsor: Zealand Pharma
This article reviews the latest research advancements regarding the use of glucagon-like peptide-2 analogs (teduglutide, glepaglutide, and apraglutide) in the treatment of SBS. Recruiting --> Active, not recruiting
- ||| glepaglutide (ZP1848) / Zealand Pharma
Trial completion date, Trial primary completion date: EASE SBS 1: Efficacy And Safety Evaluation of Glepaglutide in Treatment of Short Bowel Syndrome (SBS) (clinicaltrials.gov) - Jan 13, 2022
P3, N=129, Recruiting, Sponsor: Zealand Pharma
Recruiting --> Active, not recruiting Trial completion date: Nov 2021 --> Sep 2022 | Trial primary completion date: Oct 2021 --> Aug 2022
- || glepaglutide (ZP1848) / Zealand Pharma
Clinical, PK/PD data, Journal: PE-7: Glepaglutide Pharmacokinetic Profile after Single Subcutaneous Injection in Human Subjects with Varying Degrees of Renal Function. (Pubmed Central) - Nov 21, 2021
Trial completion date: Nov 2021 --> Sep 2022 | Trial primary completion date: Oct 2021 --> Aug 2022 No abstract available
- || glepaglutide (ZP1848) / Zealand Pharma
Clinical, PK/PD data, Journal: PE-16: Pharmacokinetics and Pharmacodynamics of Long-Acting GLP-2 Analogue Glepaglutide after Once-weekly Dosing in Adult Healthy Subjects. (Pubmed Central) - Nov 21, 2021
No abstract available No abstract available
- glepaglutide (ZP1848) / Zealand Pharma
Enrollment open: EASE SBS 4: The Long-term Effect on Intestinal Absorption and Safety of Treatment With Glepaglutide in Patients With Short Bowel Syndrome (clinicaltrials.gov) - Aug 30, 2021
P3b, N=10, Recruiting, Sponsor: Zealand Pharma
No abstract available Not yet recruiting --> Recruiting
- | glepaglutide (ZP1848) / Zealand Pharma
New P3 trial: EASE SBS 4: The Long-term Effect on Intestinal Absorption and Safety of Treatment With Glepaglutide in Patients With Short Bowel Syndrome (clinicaltrials.gov) - Aug 4, 2021
P3b, N=10, Not yet recruiting, Sponsor: Zealand Pharma
- glepaglutide (ZP1848) / Zealand Pharma
[VIRTUAL] GLEPAGLUTIDE, A NOVEL LONG-ACTING GLP-2 ANALOGUE, EXPOSURE DOES NOT CORRELATE WITH HEPATIC INDOCYANINE GREEN CLEARANCE (Poster Exhibition) - Jul 20, 2021 - Abstract #UEGW2021UEGW_4231;
Not yet recruiting --> Recruiting Plasma exposure of glepaglutide was not associated with hepatic ICG-PDR, suggesting that hepatic flow-related clearance does not contribute significantly to the overall plasma clearance of glepaglutide.
- Gattex (teduglutide) / Takeda, glepaglutide (ZP1848) / Zealand Pharma
[VIRTUAL] ACUTE INTESTINOTROPHIC EFFECTS OF SHORT AND LONG-ACTING GLP-2 ANALOGUES IN RATS (Poster Exhibition) - Jul 20, 2021 - Abstract #UEGW2021UEGW_4229;
Plasma exposure of glepaglutide was not associated with hepatic ICG-PDR, suggesting that hepatic flow-related clearance does not contribute significantly to the overall plasma clearance of glepaglutide. Long-acting GLP-2 analogue glepaglutide possess pronounced dose-dependent acute effects on both small and large intestines in contrast to short-acting teduglutide, which only demonstrated weight increase effects on the small intestine in rats.
- glepaglutide (ZP1848) / Zealand Pharma
[VIRTUAL] GLEPAGLUTIDE, A NOVEL LONG-ACTING GLP-2 ANALOGUE, EXPOSURE DOES NOT CORRELATE WITH HEPATIC INDOCYANINE GREEN CLEARANCE (Poster Exhibition) - Jul 20, 2021 - Abstract #UEGW2021UEGW_2051;
Long-acting GLP-2 analogue glepaglutide possess pronounced dose-dependent acute effects on both small and large intestines in contrast to short-acting teduglutide, which only demonstrated weight increase effects on the small intestine in rats. Plasma exposure of glepaglutide was not associated with hepatic ICG-PDR, suggesting that hepatic flow-related clearance does not contribute significantly to the overall plasma clearance of glepaglutide.
- Gattex (teduglutide) / Takeda, glepaglutide (ZP1848) / Zealand Pharma
[VIRTUAL] ACUTE INTESTINOTROPHIC EFFECTS OF SHORT AND LONG-ACTING GLP-2 ANALOGUES IN RATS (Poster Exhibition) - Jul 20, 2021 - Abstract #UEGW2021UEGW_2049;
Plasma exposure of glepaglutide was not associated with hepatic ICG-PDR, suggesting that hepatic flow-related clearance does not contribute significantly to the overall plasma clearance of glepaglutide. Long-acting GLP-2 analogue glepaglutide possess pronounced dose-dependent acute effects on both small and large intestines in contrast to short-acting teduglutide, which only demonstrated weight increase effects on the small intestine in rats.
- glepaglutide (ZP1848) / Zealand Pharma
[VIRTUAL] GLEPAGLUTIDE, A NOVEL LONG-ACTING GLP-2 ANALOGUE, EXPOSURE DOES NOT CORRELATE WITH HEPATIC INDOCYANINE GREEN CLEARANCE (Poster Exhibition) - Jul 20, 2021 - Abstract #UEGW2021UEGW_220;
Long-acting GLP-2 analogue glepaglutide possess pronounced dose-dependent acute effects on both small and large intestines in contrast to short-acting teduglutide, which only demonstrated weight increase effects on the small intestine in rats. Plasma exposure of glepaglutide was not associated with hepatic ICG-PDR, suggesting that hepatic flow-related clearance does not contribute significantly to the overall plasma clearance of glepaglutide.
- Gattex (teduglutide) / Takeda, glepaglutide (ZP1848) / Zealand Pharma
[VIRTUAL] ACUTE INTESTINOTROPHIC EFFECTS OF SHORT AND LONG-ACTING GLP-2 ANALOGUES IN RATS (Poster Exhibition) - Jul 20, 2021 - Abstract #UEGW2021UEGW_218;
Plasma exposure of glepaglutide was not associated with hepatic ICG-PDR, suggesting that hepatic flow-related clearance does not contribute significantly to the overall plasma clearance of glepaglutide. Long-acting GLP-2 analogue glepaglutide possess pronounced dose-dependent acute effects on both small and large intestines in contrast to short-acting teduglutide, which only demonstrated weight increase effects on the small intestine in rats.
- ||| glepaglutide (ZP1848) / Zealand Pharma
Trial completion: ZP1848-19045: A Bridging Trial to Compare the PK Profile When Glepaglutide is Administered Via Vial/Syringe Versus Autoinjector. (clinicaltrials.gov) - Jul 14, 2021
P1, N=85, Completed, Sponsor: Zealand Pharma
Long-acting GLP-2 analogue glepaglutide possess pronounced dose-dependent acute effects on both small and large intestines in contrast to short-acting teduglutide, which only demonstrated weight increase effects on the small intestine in rats. Recruiting --> Completed
- |||| glepaglutide (ZP1848) / Zealand Pharma
Enrollment open: EASE SBS 3: Evaluation of Long Term Safety and Efficacy of Glepaglutide in Treatment of SBS - Extension Trial (clinicaltrials.gov) - Jun 28, 2021
P3, N=129, Enrolling by invitation, Sponsor: Zealand Pharma
Recruiting --> Completed Not yet recruiting --> Enrolling by invitation
- |||||||| glepaglutide (ZP1848) / Zealand Pharma
New P3 trial: EASE SBS 3: Evaluation of Long Term Safety and Efficacy of Glepaglutide in Treatment of SBS - Extension Trial (clinicaltrials.gov) - May 10, 2021
P3, N=129, Not yet recruiting, Sponsor: Zealand Pharma
- || glepaglutide (ZP1848) / Zealand Pharma
Clinical, Journal: Effect of Glepaglutide, a Long-Acting Glucagon-Like Peptide-2 Analog, on Gastrointestinal Transit Time and Motility in Patients With Short Bowel Syndrome: Findings From a Randomized Trial. (Pubmed Central) - Mar 20, 2021
Not yet recruiting --> Enrolling by invitation The prolonged GI transit after glepaglutide treatment, along with demonstrated positive effects on intestinal mucosal growth and potential effects on GI hypersecretions, is believed to contribute to the observed beneficial effects on fecal output (primary endpoint) and associated improvement in intestinal absorption.
- || glepaglutide (ZP1848) / Zealand Pharma
Trial completion date, Trial primary completion date: ZP1848-19045: A Bridging Trial to Compare the PK Profile When Glepaglutide is Administered Via Vial/Syringe Versus Autoinjector. (clinicaltrials.gov) - Jan 6, 2021
P1, N=72, Recruiting, Sponsor: Zealand Pharma
The prolonged GI transit after glepaglutide treatment, along with demonstrated positive effects on intestinal mucosal growth and potential effects on GI hypersecretions, is believed to contribute to the observed beneficial effects on fecal output (primary endpoint) and associated improvement in intestinal absorption. Trial completion date: Sep 2020 --> May 2021 | Trial primary completion date: Sep 2020 --> May 2021
- ||| glepaglutide (ZP1848) / Zealand Pharma
Trial completion date, Trial primary completion date: EASE SBS 1: Efficacy And Safety Evaluation of Glepaglutide in Treatment of Short Bowel Syndrome (SBS) (clinicaltrials.gov) - Nov 18, 2020
P3, N=129, Recruiting, Sponsor: Zealand Pharma
Trial completion date: Sep 2020 --> May 2021 | Trial primary completion date: Sep 2020 --> May 2021 Trial completion date: Oct 2020 --> Nov 2021 | Trial primary completion date: Sep 2020 --> Oct 2021
- || glepaglutide (ZP1848) / Zealand Pharma
Trial completion, Enrollment change, Trial completion date, Trial primary completion date: Pharmacokinetic Profile of Glepaglutide After a Single Injection in Subjects With Varying Degrees of Renal Function (clinicaltrials.gov) - Nov 18, 2020
P1, N=16, Completed, Sponsor: Zealand Pharma
Trial completion date: Oct 2020 --> Nov 2021 | Trial primary completion date: Sep 2020 --> Oct 2021 Recruiting --> Completed | N=48 --> 16 | Trial completion date: Apr 2020 --> Jul 2020 | Trial primary completion date: Mar 2020 --> Jul 2020
- | apraglutide (FE 203799) / VectivBio
Journal: Pharmacological Characterization of Apraglutide a Novel Long-Acting Peptidic Glucagon-Like Peptide-2 Agonist for the Treatment of Short Bowel Syndrome. (Pubmed Central) - Sep 9, 2020
SIGNIFICANCE STATEMENT: Apraglutide is a potent and selective GLP-2 agonist with an extremely low clearance and prolonged elimination half-life, which differentiate it from teduglutide (the only approved GLP-2 agonist). The enhanced pharmacokinetics of apraglutide will benefit patients by enabling a reduced dosing frequency and removing the need for daily injections.
- | Gattex (teduglutide) / Takeda, glepaglutide (ZP1848) / Zealand Pharma
Journal: Treating short bowel syndrome with pharmacotherapy. (Pubmed Central) - Jul 7, 2020
Surgical options such as intestinal lengthening or transplantation are also addressed although these options are considerably more aggressive and have stricter indications.Expert opinion: GLP-2 analogs are the first candidates from a pioneering pharmacotherapic family within the SBS framework, namely disease-modifying, absorption-restoring agents. This family of drugs, potentially applicable in all contexts of severe intestinal loss, could become the therapeutic benchmark of the near future.