 |
8 Diseases |  |
4 Trials |
|
4 Trials |  |
93 News |  |
- | Trial completion date: SWOG-S0518: Octreotide Acetate and Recombinant Interferon Alfa-2b or Bevacizumab in Treating Patients With Metastatic or Locally Advanced, High-Risk Neuroendocrine Tumor (clinicaltrials.gov) - Mar 6, 2024
P3, N=427, Active, not recruiting, Sponsor: National Cancer Institute (NCI)
- || Rybelsus (semaglutide oral) / Novo Nordisk, Mycapssa (octreotide) / Chiesi
Review, Journal: Oral Absorption of Middle-to-Large Molecules and Its Improvement, with a Focus on New Modality Drugs. (Pubmed Central) - Jan 23, 2024
Although these two medications represent major achievements in the development of orally absorbable peptide formulations, the oral bioavailability of peptides after taking Rybelsus and Mycapssa is still only around 1%. In this article, we review the approaches and recent advances of orally bioavailable middle-to-large molecules and discuss challenges for improving their oral absorption.
- || Mycapssa (octreotide) / Chiesi
Review, Journal: Acromegaly: Pathophysiological Considerations and Treatment Options Including the Evolving Role of Oral Somatostatin Analogs. (Pubmed Central) - Sep 27, 2023
While clinical trial data supports the use of octreotide capsules (Mycapssa) in the pharmacological management of GH and IGF-1 levels, very little data exist regarding the drug's efficacy, tolerability, and use in female or pediatric-specific populations. A better understanding of the efficacy, application, and role of oral octreotide capsules in the long-term medical management of acromegaly in a diversity of populations is imperative to best determine the risks/benefits for the clinician.
- || Rybelsus (semaglutide oral) / Novo Nordisk, Mycapssa (octreotide) / Amryt
Review, Journal: Gastrointestinal Permeation Enhancers for the Development of Oral Peptide Pharmaceuticals. (Pubmed Central) - Dec 24, 2022
Sodium salcaprozate (SNAC) and sodium caprylate (C8) have been used as gastrointestinal permeation enhancers for semaglutide and octreotide, respectively. Herein, we briefly review two approved products, Rybelsus and Mycapssa, and discuss the permeation properties of SNAC and medium chain fatty acids, sodium caprate (C10) and C8, focusing on Eligen technology using SNAC, TPE technology using C8, and gastrointestinal permeation enhancement technology (GIPET) using C10.
- || Mycapssa (octreotide) / Amryt
$AMYT Amryt Announces New Patent for Mycapssa® https://t.co/dgtgNdYU24 #patent (Twitter) - Sep 13, 2022
- Mycapssa (octreotide) / Amryt
(PT10) Consistent Control for Patients with Acromegaly (In Person and Livestreamed ENDOExpo, Theater 1) - Jul 16, 2022 - Abstract #ENDO2022ENDO_3134;
Herein, we briefly review two approved products, Rybelsus and Mycapssa, and discuss the permeation properties of SNAC and medium chain fatty acids, sodium caprate (C10) and C8, focusing on Eligen technology using SNAC, TPE technology using C8, and gastrointestinal permeation enhancement technology (GIPET) using C10. This Product Theater is presented by: AMRYT PHARMA Session Description: - Describe the clinical characteristics and associated serious comorbidities of acromegaly - Utilizing an acromegaly case study, demonstrate how the road to diagnosis could be more accurate and efficient - Describe the risk to benefit profile of utilizing MYCAPSSA® (octreotide) for patients with acromegaly
- || Mycapssa (octreotide) / Amryt
$AMYT Amryt Announces Successful Bioavailability Study for Mycapssa® (octreotide capsules) https://t.co/TaOAxkmrJP (Twitter) - Mar 8, 2022
- | Rybelsus (semaglutide oral) / Novo Nordisk, Mycapssa (octreotide) / Amryt
Journal: Transient Permeation Enhancer® (TPE®) technology for oral delivery of octreotide: a technological evaluation. (Pubmed Central) - Oct 27, 2021
We evaluated the oral octreotide formulation, MYCAPSSA® (Chiasma Pharmaceuticals, Needham, MA, USA)...The oral octreotide dose required to achieve these endpoints was over 200 times that of the 0.1 mg immediate-release subcutaneous injection, a reminder of the difficulty in achieving oral absorption of macromolecules. Many acromegaly patients will prefer a convenient twice-daily oral formulation of octreotide compared to monthly depot injections.
- || Mycapssa (octreotide) / Amryt, Filsuvez (AP101) / Amryt
$AMYT Amryt Announces New Patents for Oleogel-S10 and Mycapssa® https://t.co/N9eIqWAuSE #patent (Twitter) - Oct 19, 2021
- Mycapssa (octreotide) / Chiasma
[VIRTUAL] Injection Site Reactions and Their Impact in Patients With Acromegaly Receiving Injectable Somatostatin Receptor Ligands in the Phase 3 MPOWERED Trial () - Jun 7, 2021 - Abstract #AACE2021AACE_434;
MPOWERED is a phase 3 trial assessing maintenance of response to OOC compared to iSRLs in patients with acromegaly. Here we report ISR-related data from patients receiving iSRLs in the randomized controlled treatment (RCT) phase of the MPOWERED trial.
- Mycapssa (octreotide) / Chiasma
[VIRTUAL] Improved Quality of Life and Work Productivity in Patients With Acromegaly Receiving Oral Octreotide Capsules in the Phase 3 MPOWERED Trial () - Jun 7, 2021 - Abstract #AACE2021AACE_431;
Patient-reported outcomes (PROs) are a key treatment objective in acromegaly. Validated PROs were used to assess disease and treatment burden in the MPOWERED phase 3 trial comparing oral octreotide capsules (OOC; MYCAPSSA ) to injectable SRLs (iSRLs).
- Mycapssa (octreotide) / Chiasma
[VIRTUAL] Effects of Prior Injectable Somatostatin Receptor Ligand Type and Dose in Patients With Acromegaly Receiving Oral Octreotide Capsules in the Phase 3 MPOWERED Trial () - Jun 7, 2021 - Abstract #AACE2021AACE_383;
MPOWERED is a phase 3 trial assessing maintenance of response to OOC compared to iSRLs in acromegaly. Here we report outcomes in patients receiving OOC based on their prior iSRL treatment (octreotide or lanreotide).
- Mycapssa (octreotide) / Chiasma
[VIRTUAL] Improved Quality of Life and Work Productivity in Patients With Acromegaly Receiving Oral Octreotide Capsules in the Phase 3 MPOWERED Trial () - May 16, 2021 - Abstract #AACE2021AACE_99;
As patients served as their own control, the analysis was highly sensitive in the Run-in phase. Significant differences between treatment arms were not observed during the RCT phase, potentially due to sample size and variability of the measures.
- Mycapssa (octreotide) / Chiasma
[VIRTUAL] Understanding the Management of Acromegaly with MYCAPSSAa (octreotide) Delayed-Release Oral Capsules presented by Chiasma () - May 16, 2021 - Abstract #AACE2021AACE_61;
Monitor patients periodically. Discontinue if complications of cholelithiasis are suspected.
- cabergoline / Generic mfg.
[VIRTUAL] Addition of Cabergoline to Oral Octreotide Capsules May Improve Biochemical Control in Patients With Acromegaly Who Are Inadequately Controlled With Monotherapy () - Mar 27, 2021 - Abstract #ENDO2021ENDO_3334;
Addition of cabergoline to OOC yielded biochemical control improvement (IGF-I reduction) in patients inadequately controlled with OOC monotherapy. As both combination and OOC monotherapy safety profiles were similar, adjunctive cabergoline may be helpful in patients with acromegaly who do not achieve adequate biochemical control on OOC alone.
- Mycapssa (octreotide) / Chiasma
[VIRTUAL] A Phase 3 Large International Noninferiority Trial (MPOWERED): Assessing Maintenance of Response to Oral Octreotide Capsules in Comparison to Injectable Somatostatin Receptor Ligands () - Mar 27, 2021 - Abstract #ENDO2021ENDO_3333;
Background : MPOWERED, a large phase 3 trial, assessed maintenance of response to oral octreotide capsules (OOC; MYCAPSSA ® ) compared to injectable somatostatin receptor ligands (iSRLs) in patients with acromegaly who responded to OOC and iSRLs (octreotide or lanreotide)...For oral presentations, the abstracts are embargoed until the session begins. The Endocrine Society reserves the right to lift the embargo on specific abstracts that are selected for promotion prior to or during ENDO 2021.
- Mycapssa (octreotide) / Chiasma
[VIRTUAL] Improved Acromegaly Patient Satisfaction With Oral Octreotide Capsules Compared With Injectable Somatostatin Receptor Ligands in the MPOWERED Trial () - Mar 27, 2021 - Abstract #ENDO2021ENDO_3331;
Validated PROs were used to assess disease and treatment burden in the MPOWERED phase 3 trial in acromegaly, which also assessed safety and efficacy of oral octreotide capsules (OOC; MYCAPSSA ® ) compared to injectable SRLs (iSRLs)...Breakthrough symptoms were reported more frequently with iSRLs (31%) than OOC (15%) at the end of RCT. Conclusion : Higher patient satisfaction, convenience and emotional well-being, and improved symptom control based on the newly validated Acro-TSQ PRO reporting tool were observed with OOC compared to iSRLs in patients enrolled in the MPOWERED trial.
- Mycapssa (octreotide) / Chiasma
[VIRTUAL] Safety Results From MPOWERED, a Phase 3 Trial of Oral Octreotide Capsules in Adults With Acromegaly () - Mar 27, 2021 - Abstract #ENDO2021ENDO_3330;
19 patients (34.5%) in the OOC and 15 (40.5%) in the iSRL group had treatment-related TEAEs. Occurrence was similar for serious AEs (OOC, 5.5%; iSRL, 8.1%) as well as TEAEs classified as severe (OOC, 9.1%; iSRL, 10.8%).
- Mycapssa (octreotide) / Chiasma
[VIRTUAL] Oral Octreotide Capsules Lowered Incidence and Improved Severity of Acromegaly Symptoms Compared to Injectable Somatostatin Receptor Ligands—Results From the MPOWERED Trial () - Mar 27, 2021 - Abstract #ENDO2021ENDO_3328;
The phase 3 MPOWERED trial assessed control of acromegaly by oral octreotide capsules (OOC; MYCAPSSA ® ) in comparison to injectable somatostatin receptor ligands (iSRLs) in patients responding to both OOC and iSRLs...Conclusion : Results from MPOWERED show that patients receiving OOC had significant improvement in number and severity of acromegaly symptoms after switching from iSRLs. These findings validate previous results from a phase 3 study of OOC in acromegaly in which patients switching to OOC from iSRLs showed significant reduction in joint pain, extremity swelling, and fatigue.
- Mycapssa (octreotide) / Chiasma
[VIRTUAL] PT01. Acromegaly and the Role of Oral Octreotide (MYCAPSSA) in its Management () - Mar 27, 2021 - Abstract #ENDO2021ENDO_3098;
Monitor patients periodically. Discontinue if complications of cholelithiasis are suspected.
- || Mycapssa (octreotide) / Chiesi
Trial completion date: OPTIMAL: Efficacy and Safety of Octreotide Capsules (MYCAPSSA) in Acromegaly (clinicaltrials.gov) - Oct 19, 2020
P3, N=56, Active, not recruiting, Sponsor: Chiasma, Inc.
Discontinue if complications of cholelithiasis are suspected. Trial completion date: May 2020 --> May 2022
- | Mycapssa (octreotide) / Chiasma
$CHMA Announces U.S. Commercial Launch and Availability of MYCAPSSA (Twitter) - Aug 31, 2020
- || Mycapssa (octreotide) / Chiasma
The prescription: Take MYCAPSSA orally with a glass of water on an empty stomach, at least 1 hour before a meal or at least 2 hours after a meal. Recommended Dosage, Titration, and Monitoring. Initiate at a dosage of 40 mg daily, administered as 20 mg orally twice daily. (Twitter) - Jul 1, 2020
- ||| Mycapssa (octreotide) / Chiasma
FDA event: Chiasma secures FDA approval for acromegaly pill Mycapssa years after near-catastrophic rejection https://t.co/asDBd6mBhO (Twitter) - Jun 26, 2020
- || Mycapssa (octreotide) / Chiasma
NDA, PDUFA date: $CHMA Announces FDA Acceptance of MYCAPSSA NDA Resubmission. PDUFA 06/26/20 (Twitter) - Jan 13, 2020
- | Mycapssa (octreotide) / Chiesi
Trial primary completion date: OPTIMAL: Efficacy and Safety of Octreotide Capsules (MYCAPSSA) in Acromegaly (clinicaltrials.gov) - Sep 14, 2019
P3, N=56, Active, not recruiting, Sponsor: Chiasma, Inc.
Trial completion date: May 2020 --> May 2022 Trial primary completion date: Dec 2019 --> Jun 2019
- | Mycapssa (octreotide) / Chiesi
Enrollment closed: OPTIMAL: Efficacy and Safety of Octreotide Capsules (MYCAPSSA) in Acromegaly (clinicaltrials.gov) - Oct 3, 2018
P3, N=56, Active, not recruiting, Sponsor: Chiasma, Inc.
Trial primary completion date: Dec 2019 --> Jun 2019 Recruiting --> Active, not recruiting
- | Mycapssa (octreotide) / Chiesi
Enrollment open: OPTIMAL: Efficacy and Safety of Octreotide Capsules (MYCAPSSA) in Acromegaly (clinicaltrials.gov) - Sep 5, 2017
P3, N=50, Recruiting, Sponsor: Chiasma, Inc.
Recruiting --> Active, not recruiting Not yet recruiting --> Recruiting
- ||| Mycapssa (octreotide) / Amryt
Clinical: OPTIMAL: Efficacy and Safety of Octreotide Capsules (MYCAPSSA) in Acromegaly (clinicaltrials.gov) - Aug 17, 2017
P3, N=50, Not yet recruiting, Sponsor: Chiasma, Inc.
- | Mycapssa (octreotide) / Chiesi
Enrollment closed: Efficacy and Safety of Octreotide (MYCAPSSA (clinicaltrials.gov) - Mar 24, 2014
P3, N=150, Active, not recruiting, Sponsor: Chiasma, Inc.
Not yet recruiting --> Recruiting Recruiting --> Active, not recruiting
- | Enrollment closed: SWOG-S0518: Octreotide Acetate and Recombinant Interferon Alfa-2b or Bevacizumab in Treating Patients With Metastatic or Locally Advanced, High-Risk Neuroendocrine Tumor (clinicaltrials.gov) - Feb 26, 2013
P3, N=400, Active, not recruiting, Sponsor: National Cancer Institute (NCI)
Recruiting --> Active, not recruiting Recruiting --> Active, not recruiting
- || Mycapssa (octreotide) / Chiesi
New P3 trial: Efficacy and Safety of Octreotide (MYCAPSSA (clinicaltrials.gov) - Aug 7, 2011
P3, N=150, Active, not recruiting, Sponsor: Chiasma, Inc.