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- || Review, Journal: Emerging trends in antipsychotic and antidepressant drug development: Targeting nonmonoamine receptors and innovative mechanisms. (Pubmed Central) - Jun 13, 2024
Additionally, TAK-653 (NBI-1065845) and MJI821 (Onfasprodil) have emerged as potential antidepressants targeting AMPA receptors and NMDA receptor 2B (NR2B) negative allosteric modulation, respectively...By focusing on nonmonoamine receptors and introducing innovative mechanisms, these drugs offer a promising prospect of improved outcomes for individuals suffering from schizophrenia and MDD. Thus, sustained attention and dedication to the development of such drugs are essential to augmenting the therapeutic options available for psychiatric patients.
- || onfasprodil intravenous (MIJ821 IV) / Novartis
P1 data, Journal: MIJ821 (onfasprodil) in healthy volunteers: First-in-human, randomized, placebo-controlled study (single ascending dose and repeated intravenous dose). (Pubmed Central) - Nov 27, 2023
In conclusion, MIJ821 showed a good safety and tolerability profile in healthy volunteers. Dissociative AEs were mild, transient, and dose-dependent.
- ||||| onfasprodil intravenous (MIJ821 IV) / Novartis
Trial completion date, Trial termination: Study of Efficacy and Safety of MIJ821 in Addition to Comprehensive Standard of Care on the Rapid Reduction of Symptoms of Major Depressive Disorder in Subjects Who Have Suicidal Ideation With Intent (clinicaltrials.gov) - Nov 1, 2023
P2, N=200, Terminated, Sponsor: Novartis Pharmaceuticals
Dissociative AEs were mild, transient, and dose-dependent. Trial completion date: Aug 2024 --> Sep 2023 | Active, not recruiting --> Terminated; Terminated by Novartis
- || onfasprodil intravenous (MIJ821 IV) / Novartis
Enrollment closed, Trial completion date: Study of Efficacy and Safety of MIJ821 in Addition to Comprehensive Standard of Care on the Rapid Reduction of Symptoms of Major Depressive Disorder in Subjects Who Have Suicidal Ideation With Intent (clinicaltrials.gov) - Oct 30, 2023
P2, N=195, Active, not recruiting, Sponsor: Novartis Pharmaceuticals
Trial completion date: Aug 2024 --> Sep 2023 | Active, not recruiting --> Terminated; Terminated by Novartis Terminated --> Active, not recruiting | Trial completion date: Jul 2023 --> Aug 2024
- ||||| onfasprodil intravenous (MIJ821 IV) / Novartis
Trial completion date, Trial termination, Trial primary completion date: Study of Efficacy and Safety of MIJ821 in Addition to Comprehensive Standard of Care on the Rapid Reduction of Symptoms of Major Depressive Disorder in Subjects Who Have Suicidal Ideation With Intent (clinicaltrials.gov) - Oct 6, 2023
P2, N=199, Terminated, Sponsor: Novartis Pharmaceuticals
Terminated --> Active, not recruiting | Trial completion date: Jul 2023 --> Aug 2024 Trial completion date: Oct 2024 --> Jul 2023 | Active, not recruiting --> Terminated | Trial primary completion date: Mar 2023 --> Jul 2023; Terminated by Novartis
- || onfasprodil intravenous (MIJ821 IV) / Novartis
Enrollment closed, Trial primary completion date: Study of Efficacy and Safety of MIJ821 in Addition to Comprehensive Standard of Care on the Rapid Reduction of Symptoms of Major Depressive Disorder in Subjects Who Have Suicidal Ideation With Intent (clinicaltrials.gov) - Aug 29, 2023
P2, N=199, Active, not recruiting, Sponsor: Novartis Pharmaceuticals
Trial completion date: Oct 2024 --> Jul 2023 | Active, not recruiting --> Terminated | Trial primary completion date: Mar 2023 --> Jul 2023; Terminated by Novartis Recruiting --> Active, not recruiting | Trial primary completion date: Aug 2024 --> Mar 2023
- || onfasprodil intravenous (MIJ821 IV) / Novartis
Trial completion date, Trial primary completion date: Study of Efficacy and Safety of MIJ821 in Addition to Comprehensive Standard of Care on the Rapid Reduction of Symptoms of Major Depressive Disorder in Subjects Who Have Suicidal Ideation With Intent (clinicaltrials.gov) - Jul 13, 2023
P2, N=195, Recruiting, Sponsor: Novartis Pharmaceuticals
Recruiting --> Active, not recruiting | Trial primary completion date: Aug 2024 --> Mar 2023 Trial completion date: May 2024 --> Aug 2024 | Trial primary completion date: May 2024 --> Aug 2024
- || onfasprodil intravenous (MIJ821 IV) / Novartis
Enrollment open, Trial completion date, Trial primary completion date: An Open-label, Adaptive Design, Positron Emission Tomography Study in Healthy Male Participants to Characterize Receptor Occupancy by MIJ821 in the Brain (clinicaltrials.gov) - Jun 18, 2023
P1, N=10, Recruiting, Sponsor: Novartis Pharmaceuticals
Trial completion date: May 2024 --> Aug 2024 | Trial primary completion date: May 2024 --> Aug 2024 Not yet recruiting --> Recruiting | Trial completion date: May 2023 --> Nov 2023 | Trial primary completion date: Apr 2023 --> Nov 2023
- || onfasprodil intravenous (MIJ821 IV) / Novartis
New P1 trial: An Open-label, Adaptive Design, Positron Emission Tomography Study in Healthy Male Participants to Characterize Receptor Occupancy by MIJ821 in the Brain (clinicaltrials.gov) - Dec 28, 2022
P1, N=10, Not yet recruiting, Sponsor: Novartis Pharmaceuticals
- |||| onfasprodil intravenous (MIJ821 IV) / Novartis
New P2 trial: Study of efficacy, safety, tolerability and pharmacokinetics of MIJ821 in participants with treatment- resistant depression (TRD) Estudio de eficacia, seguridad, tolerabilidad y farmacocin (EUDRACT) - Nov 1, 2022
P2, N=56, Ongoing, Sponsor: Novartis Farmac
- || onfasprodil intravenous (MIJ821 IV) / Novartis
Trial completion date, Trial primary completion date: Study of Efficacy and Safety of MIJ821 in Addition to Comprehensive Standard of Care on the Rapid Reduction of Symptoms of Major Depressive Disorder in Subjects Who Have Suicidal Ideation With Intent (clinicaltrials.gov) - Oct 18, 2022
P2, N=195, Recruiting, Sponsor: Novartis Pharmaceuticals
Not yet recruiting --> Recruiting | Trial completion date: May 2023 --> Nov 2023 | Trial primary completion date: Apr 2023 --> Nov 2023 Trial completion date: Jan 2024 --> May 2024 | Trial primary completion date: Jan 2024 --> May 2024
- MIJ821 IV / Novartis
Discovery and first disclosure of MIJ821, a novel, rapidly acting antidepressant (W183a (McCormick Place Convention Center)) - Aug 9, 2022 - Abstract #ACSFall2022ACS_Fall_10347;
We will present the discovery of MIJ821 in collaboration with biotech partners. We will include a story of scaffold morphing from a literature lead, balancing properties, in particular hERG and PGP efflux to ensure brain exposure, a target engagement imaging strategy, and a summary of the Phase 1 and Phase 2 clinical data that has led to this molecule moving into full clinical development.
- ||| Clinical, P2 data, P3 data, Review, Journal: Novel Antidepressants in the Pipeline (Phase II and III): A Systematic Review of the US Clinical Trials Registry. (Pubmed Central) - Jul 10, 2022
We will include a story of scaffold morphing from a literature lead, balancing properties, in particular hERG and PGP efflux to ensure brain exposure, a target engagement imaging strategy, and a summary of the Phase 1 and Phase 2 clinical data that has led to this molecule moving into full clinical development. These new compounds with novel mechanisms of action are expected to provide a greater variety of treatment options for depression if preliminary positive results are confirmed.
- ||| onfasprodil intravenous (MIJ821 IV) / Novartis
Enrollment open: Study of Efficacy and Safety of MIJ821 in Addition to Comprehensive Standard of Care on the Rapid Reduction of Symptoms of Major Depressive Disorder in Subjects Who Have Suicidal Ideation With Intent (clinicaltrials.gov) - Jun 8, 2021
P2, N=195, Recruiting, Sponsor: Novartis Pharmaceuticals
These new compounds with novel mechanisms of action are expected to provide a greater variety of treatment options for depression if preliminary positive results are confirmed. Not yet recruiting --> Recruiting
- MIJ821 / Novartis
[VIRTUAL] Efficacy and Safety of MIJ821 in Patients With Treatment-Resistant Depression: Results From a Randomized, Placebo-Controlled, Proof-of-Concept Study () - May 2, 2021 - Abstract #APA2021APA_944;
P2
In this proof-of-concept study, MIJ821 was associated with a significant improvement in MADRS score vs. placebo in patients with TRD. No new safety signals were identified.
- MIJ821 / Novartis
[VIRTUAL] Efficacy and safety of MIJ821 in patients with treatment-resistant depression: Results from a randomized, placebo-controlled, proof-of-concept study (e-Poster Gallery) - Apr 26, 2021 - Abstract #EPA2021EPA_1100;
P2
This study was funded by Novartis. Clinical trial.gov: NCT03756129
- |||| onfasprodil intravenous (MIJ821 IV) / Novartis
New P2 trial: Study of Efficacy and Safety of MIJ821 in Addition to Comprehensive Standard of Care on the Rapid Reduction of Symptoms of Major Depressive Disorder in Subjects Who Have Suicidal Ideation With Intent (clinicaltrials.gov) - Jan 25, 2021
P2, N=195, Not yet recruiting, Sponsor: Novartis Pharmaceuticals
- ||| onfasprodil intravenous (MIJ821 IV) / Novartis
Trial completion: Proof of Concept Study Evaluating the Efficacy and Safety of MIJ821 in Patients With Treatment-resistant Depression (clinicaltrials.gov) - May 11, 2020
P2, N=72, Completed, Sponsor: Novartis Pharmaceuticals
Clinical trial.gov: NCT03756129 Active, not recruiting --> Completed
- || onfasprodil intravenous (MIJ821 IV) / Novartis
Enrollment closed: Proof of Concept Study Evaluating the Efficacy and Safety of MIJ821 in Patients With Treatment-resistant Depression (clinicaltrials.gov) - Feb 18, 2020
P2, N=72, Active, not recruiting, Sponsor: Novartis Pharmaceuticals
Active, not recruiting --> Completed Recruiting --> Active, not recruiting
- ||| onfasprodil intravenous (MIJ821 IV) / Novartis
Enrollment open: Proof of Concept Study Evaluating the Efficacy and Safety of MIJ821 in Patients With Treatment-resistant Depression (clinicaltrials.gov) - Mar 8, 2019
P2, N=66, Recruiting, Sponsor: Novartis Pharmaceuticals
Recruiting --> Active, not recruiting Not yet recruiting --> Recruiting
- | onfasprodil intravenous (MIJ821 IV) / Novartis
New P2 trial: Proof of Concept Study Evaluating the Efficacy and Safety of MIJ821 in Patients With Treatment-resistant Depression (clinicaltrials.gov) - Nov 28, 2018
P2, N=66, Not yet recruiting, Sponsor: Novartis Pharmaceuticals