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- || Review, Journal: Investigational drugs for the Treatment of Acromegaly: new agents to transform therapy. (Pubmed Central) - Jun 7, 2024
Current studies are addressing patient's needing for both new molecules and less invasive routes of administration for already existing drugs. It cannot be ruled out that drugs currently used for other disease such as cancers could be considered in the future for the treatment of acromegaly.
- || cimdelirsen (IONIS-GHR-LRx) / Ionis
Trial completion, Trial completion date, Trial primary completion date, Monotherapy: A Study to Assess the Safety, Tolerability, and Efficacy of IONIS-GHR-LRx Administered in Patients With Acromegaly (clinicaltrials.gov) - Jun 6, 2023
P2, N=34, Completed, Sponsor: Ionis Pharmaceuticals, Inc.
It cannot be ruled out that drugs currently used for other disease such as cancers could be considered in the future for the treatment of acromegaly. Active, not recruiting --> Completed | Trial completion date: Oct 2023 --> May 2023 | Trial primary completion date: Aug 2023 --> Jul 2022
- | cimdelirsen (IONIS-GHR-LRx) / Ionis
Trial primary completion date: Extension Study of IONIS-GHR-LRx Administered to Participants With Acromegaly Being Treated With Long-acting Somatostatin Receptor Ligands (clinicaltrials.gov) - Aug 8, 2022
P2, N=39, Completed, Sponsor: Ionis Pharmaceuticals, Inc.
Active, not recruiting --> Completed | Trial completion date: Oct 2023 --> May 2023 | Trial primary completion date: Aug 2023 --> Jul 2022 Trial primary completion date: Jul 2022 --> Mar 2022
- || cimdelirsen (IONIS-GHR-LRx) / Ionis
Trial completion, Trial completion date, Trial primary completion date: Extension Study of IONIS-GHR-LRx Administered to Participants With Acromegaly Being Treated With Long-acting Somatostatin Receptor Ligands (clinicaltrials.gov) - Jul 28, 2022
P2, N=39, Completed, Sponsor: Ionis Pharmaceuticals, Inc.
Trial primary completion date: Jul 2022 --> Mar 2022 Active, not recruiting --> Completed | Trial completion date: Jul 2023 --> Jul 2022 | Trial primary completion date: Jul 2023 --> Jul 2022
- cimdelirsen (IONIS-GHR-LRx) / Ionis
Placebo-Controlled and Open-Label Extension Study of a Novel Hepatic-Targeted Antisense Cimdelirsen (IONIS-GHR-LRx) Under Investigation in Acromegaly Patients) (In Person and Livestreamed A313-A314) - Jul 16, 2022 - Abstract #ENDO2022ENDO_2430;
P2
Once monthly SC cimdelirsen injections demonstrated long-term safety, were well-tolerated, and resulted in significant reductions in GHBP and IGF-1 AUC without increased GH levels. Cimdelirsen also improved PRO, collectively supporting further development of this novel, liver-directed potential therapy for uncontrolled acromegaly.
- | cimdelirsen (IONIS-GHR-LRx) / Ionis
Enrollment closed, Monotherapy: A Study to Assess the Safety, Tolerability, and Efficacy of IONIS-GHR-LRx Administered in Patients With Acromegaly (clinicaltrials.gov) - Jan 9, 2022
P2, N=40, Active, not recruiting, Sponsor: Ionis Pharmaceuticals, Inc.
Cimdelirsen also improved PRO, collectively supporting further development of this novel, liver-directed potential therapy for uncontrolled acromegaly. Recruiting --> Active, not recruiting
- | cimdelirsen (IONIS-GHR-LRx) / Ionis
Enrollment closed: Extension Study of IONIS-GHR-LRx Administered to Participants With Acromegaly Being Treated With Long-acting Somatostatin Receptor Ligands (clinicaltrials.gov) - Jul 12, 2021
P2, N=39, Active, not recruiting, Sponsor: Ionis Pharmaceuticals, Inc.
Recruiting --> Active, not recruiting Enrolling by invitation --> Active, not recruiting
- ||| cimdelirsen (IONIS-GHR-LRx) / Ionis
Enrollment change: Extension Study of IONIS-GHR-LRx Administered to Participants With Acromegaly Being Treated With Long-acting Somatostatin Receptor Ligands (clinicaltrials.gov) - May 19, 2021
P2, N=39, Enrolling by invitation, Sponsor: Ionis Pharmaceuticals, Inc.
Enrolling by invitation --> Active, not recruiting N=60 --> 39
- || cimdelirsen (IONIS-GHR-LRx) / Ionis
Trial completion: Safety, Tolerability, and Efficacy of IONIS-GHR-LRx in Participants With Acromegaly Being Treated With Long-acting Somatostatin Receptor Ligands (clinicaltrials.gov) - May 18, 2021
P2, N=43, Completed, Sponsor: Ionis Pharmaceuticals, Inc.
N=60 --> 39 Active, not recruiting --> Completed
- || cimdelirsen (IONIS-GHR-LRx) / Ionis
Enrollment status: Extension Study of IONIS-GHR-LRx Administered to Participants With Acromegaly Being Treated With Long-acting Somatostatin Receptor Ligands (clinicaltrials.gov) - Feb 21, 2021
P2, N=60, Enrolling by invitation, Sponsor: Ionis Pharmaceuticals, Inc.
Active, not recruiting --> Completed Recruiting --> Enrolling by invitation
- | cimdelirsen (IONIS-GHR-LRx) / Ionis
Trial completion date, Trial primary completion date, Monotherapy: A Study to Assess the Safety, Tolerability, and Efficacy of IONIS-GHR-LRx Administered in Patients With Acromegaly (clinicaltrials.gov) - Feb 2, 2021
P2, N=40, Recruiting, Sponsor: Ionis Pharmaceuticals, Inc.
Recruiting --> Enrolling by invitation Trial completion date: Apr 2023 --> Aug 2023 | Trial primary completion date: Apr 2023 --> Aug 2023
- | cimdelirsen (IONIS-GHR-LRx) / Ionis
Trial completion date: Safety, Tolerability, and Efficacy of IONIS-GHR-LRx in Participants With Acromegaly Being Treated With Long-acting Somatostatin Receptor Ligands (clinicaltrials.gov) - Jan 11, 2021
P2, N=43, Active, not recruiting, Sponsor: Ionis Pharmaceuticals, Inc.
Trial completion date: Apr 2023 --> Aug 2023 | Trial primary completion date: Apr 2023 --> Aug 2023 Trial completion date: Dec 2020 --> Apr 2021
- || cimdelirsen (IONIS-GHR-LRx) / Ionis
Trial completion date, Trial primary completion date: Extension Study of IONIS-GHR-LRx Administered to Participants With Acromegaly Being Treated With Long-acting Somatostatin Receptor Ligands (clinicaltrials.gov) - Jan 11, 2021
P2, N=60, Recruiting, Sponsor: Ionis Pharmaceuticals, Inc.
Trial completion date: Dec 2020 --> Apr 2021 Trial completion date: Jan 2021 --> Jun 2023 | Trial primary completion date: Jan 2021 --> Jun 2023
- | cimdelirsen (IONIS-GHR-LRx) / Ionis
Enrollment closed: Safety, Tolerability, and Efficacy of IONIS-GHR-LRx in Participants With Acromegaly Being Treated With Long-acting Somatostatin Receptor Ligands (clinicaltrials.gov) - Dec 19, 2020
P2, N=43, Active, not recruiting, Sponsor: Ionis Pharmaceuticals, Inc.
Trial completion date: Jan 2021 --> Jun 2023 | Trial primary completion date: Jan 2021 --> Jun 2023 Recruiting --> Active, not recruiting
- || cimdelirsen (IONIS-GHR-LRx) / Ionis
Trial completion date, Trial primary completion date: Safety, Tolerability, and Efficacy of IONIS-GHR-LRx in Participants With Acromegaly Being Treated With Long-acting Somatostatin Receptor Ligands (clinicaltrials.gov) - Dec 7, 2020
P2, N=60, Recruiting, Sponsor: Ionis Pharmaceuticals, Inc.
Recruiting --> Active, not recruiting Trial completion date: Jul 2020 --> Dec 2020 | Trial primary completion date: Jul 2020 --> Dec 2020
- || cimdelirsen (IONIS-GHR-LRx) / Ionis
Enrollment open, Trial initiation date, Monotherapy: A Study to Assess the Safety, Tolerability, and Efficacy of IONIS-GHR-LRx Administered in Patients With Acromegaly (clinicaltrials.gov) - Oct 28, 2020
P2, N=40, Recruiting, Sponsor: Ionis Pharmaceuticals, Inc.
Trial completion date: Jul 2020 --> Dec 2020 | Trial primary completion date: Jul 2020 --> Dec 2020 Not yet recruiting --> Recruiting | Initiation date: Sep 2020 --> Dec 2020
- || cimdelirsen (IONIS-GHR-LRx) / Ionis
New P2 trial, Monotherapy: A Study to Assess the Safety, Tolerability, and Efficacy of IONIS-GHR-LRx Administered in Patients With Acromegaly (clinicaltrials.gov) - Aug 20, 2020
P2, N=40, Not yet recruiting, Sponsor: Ionis Pharmaceuticals, Inc.
- || cimdelirsen (IONIS-GHR-LRx) / Ionis
Trial completion date, Trial primary completion date: Safety, Tolerability, and Efficacy of IONIS-GHR-LRx in Participants With Acromegaly Being Treated With Long-acting Somatostatin Receptor Ligands (clinicaltrials.gov) - Nov 4, 2019
P2, N=60, Recruiting, Sponsor: Ionis Pharmaceuticals, Inc.
Not yet recruiting --> Recruiting | Initiation date: Sep 2020 --> Dec 2020 Trial completion date: Dec 2019 --> Jul 2020 | Trial primary completion date: Sep 2019 --> Jul 2020
- | cimdelirsen (IONIS-GHR-LRx) / Ionis
Enrollment change: Extension Study of IONIS-GHR-LRx Administered to Participants With Acromegaly Being Treated With Long-acting Somatostatin Receptor Ligands (clinicaltrials.gov) - Sep 24, 2019
P2, N=60, Recruiting, Sponsor: Ionis Pharmaceuticals, Inc.
Trial completion date: Dec 2019 --> Jul 2020 | Trial primary completion date: Sep 2019 --> Jul 2020 N=42 --> 60
- | cimdelirsen (IONIS-GHR-LRx) / Ionis
Enrollment open: Extension Study of IONIS-GHR-LRx Administered to Participants With Acromegaly Being Treated With Long-acting Somatostatin Receptor Ligands (clinicaltrials.gov) - Jul 28, 2019
P2, N=42, Recruiting, Sponsor: Ionis Pharmaceuticals, Inc.
N=42 --> 60 Not yet recruiting --> Recruiting
- ||| cimdelirsen (IONIS-GHR-LRx) / Ionis
Enrollment change: Safety, Tolerability, and Efficacy of IONIS-GHR-LRx in Participants With Acromegaly Being Treated With Long-acting Somatostatin Receptor Ligands (clinicaltrials.gov) - Jul 5, 2019
P2, N=60, Recruiting, Sponsor: Ionis Pharmaceuticals, Inc.
Not yet recruiting --> Recruiting N=42 --> 60
- || cimdelirsen (IONIS-GHR-LRx) / Ionis
New P2 trial: Extension Study of IONIS-GHR-LRx Administered to Participants With Acromegaly Being Treated With Long-acting Somatostatin Receptor Ligands (clinicaltrials.gov) - May 29, 2019
P2, N=42, Not yet recruiting, Sponsor: Ionis Pharmaceuticals, Inc.
- || cimdelirsen (IONIS-GHR-LRx) / Ionis
Enrollment open: Safety, Tolerability, and Efficacy of IONIS-GHR-LRx in Participants With Acromegaly Being Treated With Long-acting Somatostatin Receptor Ligands (clinicaltrials.gov) - Jun 27, 2018
P2, N=42, Recruiting, Sponsor: Ionis Pharmaceuticals, Inc.
N=42 --> 60 Not yet recruiting --> Recruiting
- || cimdelirsen (IONIS-GHR-LRx) / Ionis
New P2 trial: Safety, Tolerability, and Efficacy of IONIS-GHR-LRx in Participants With Acromegaly Being Treated With Long-acting Somatostatin Receptor Ligands (clinicaltrials.gov) - Jun 6, 2018
P2, N=42, Not yet recruiting, Sponsor: Ionis Pharmaceuticals, Inc.