ropanicant (SUVN-911) / Suven Life Sci - LARVOL DELTA

Ropanicant (SUVN-911), an α4β2 nAChR antagonist: Results from a Phase-2a Study Evaluating Safety and Efficacy in Participants with Moderate to Severe Major Depressive Disorder (Neuroscience 2025) - P2 | "The statistically significant improvements in MADRS scores suggest potential antidepressant benefits of Ropanicant. Based on these findings, a Phase 2b randomized, double-blind, placebo-controlled, parallel-group, multicenter trial (NCT06836063) has been initiated to further evaluate the efficacy and safety of Ropanicant in participants with MDD."

Clinical • P2a data • CNS Disorders • Depression • Major Depressive Disorder • Mood Disorders • Psychiatry • Suicidal Ideation

Study to Evaluate Efficacy and Safety of Ropanicant in MDD Patients (clinicaltrials.gov) - P2 | N=195 | Recruiting | Sponsor: Suven Life Sciences Limited | Not yet recruiting ➔ Recruiting

Enrollment open • CNS Disorders • Depression • Major Depressive Disorder • Mood Disorders • Psychiatry

Study to Evaluate Efficacy and Safety of Ropanicant in MDD Patients (clinicaltrials.gov) - P2 | N=195 | Not yet recruiting | Sponsor: Suven Life Sciences Limited

New P2 trial • CNS Disorders • Depression • Major Depressive Disorder • Mood Disorders • Psychiatry

Study Evaluating Safety and Efficacy of Ropanicant in MDD Patients (clinicaltrials.gov) - P2 | N=41 | Completed | Sponsor: Suven Life Sciences Limited | Active, not recruiting ➔ Completed

Trial completion • CNS Disorders • Depression • Major Depressive Disorder • Mood Disorders • Psychiatry

Ropanicant (SUVN-911), an α4β2 nAChR Antagonist: A Phase-2 Study Evaluating the Safety and Efficacy in Participants with Moderate to Severe Major Depressive Disorder (Neuroscience 2024) - P2 | "The results will be presented at the Society for Neuroscience conference. This open-label study will be a preface to a future double-blind placebo controlled study of ropanicant in participants with MDD."

Clinical • P2 data • CNS Disorders • Depression • Major Depressive Disorder • Mood Disorders • Psychiatry • Suicidal Ideation

Study Evaluating Safety and Efficacy of Ropanicant in MDD Patients (clinicaltrials.gov) - P2 | N=41 | Active, not recruiting | Sponsor: Suven Life Sciences Limited | Recruiting ➔ Active, not recruiting

Enrollment closed • CNS Disorders • Depression • Major Depressive Disorder • Mood Disorders • Psychiatry

Ropanicant (SUVN-911), a α4β2 Receptor Antagonist: A Phase-2 Study Evaluating the Safety and Efficacy in Participants with Moderate to Severe Major Depressive Disorder (ASCP 2024) - P2 | "Demographics and baseline characteristics of the recruited subjects will be presented during the conference. Learning Objectives 1.To understand the safety of Ropanicant, an α4β2 antagonist, in participants with major depressive disorder 2.To understand the efficacy of Ropanicant, an α4β2 antagonist, in participants with major depressive disorder"

Clinical • P2 data • CNS Disorders • Depression • Major Depressive Disorder • Mood Disorders • Psychiatry • Suicidal Ideation

Effect of Ropanicant (SUVN-911), an α4β2 Receptor Antagonist in Animal Models of Depression (ASCP 2024) - P2 | "Learning Objectives 1.Evaluate the non-clinical efficacy of ropanicant an α4β2 receptor antagonist in animal models of depression. 2.To understand the differentiating features of ropanicant over current standards of care with respect to onset of action and side effects profile"

Preclinical • CNS Disorders • Depression • Major Depressive Disorder • Mood Disorders • Psychiatry • BDNF

Study Evaluating Safety and Efficacy of Ropanicant in MDD Patients (clinicaltrials.gov) - P2 | N=36 | Recruiting | Sponsor: Suven Life Sciences Limited | Not yet recruiting ➔ Recruiting

Enrollment open • CNS Disorders • Depression • Major Depressive Disorder • Mood Disorders • Psychiatry

Study Evaluating Safety and Efficacy of Ropanicant in MDD Patients (clinicaltrials.gov) - P2 | N=36 | Not yet recruiting | Sponsor: Suven Life Sciences Limited

Trial completion date • Trial initiation date • Trial primary completion date • CNS Disorders • Depression • Major Depressive Disorder • Mood Disorders • Psychiatry

Study Evaluating Safety and Efficacy of Ropanicant in MDD Patients (clinicaltrials.gov) - P2 | N=36 | Not yet recruiting | Sponsor: Suven Life Sciences Limited

New P2 trial • CNS Disorders • Depression • Major Depressive Disorder • Mood Disorders • Psychiatry

Ropanicant (SUVN-911), an α4β2 nAChR antagonist: A phase-2a study evaluating the safety and efficacy in participants with moderate to severe major depressive disorder (Neuroscience 2023) - "Pharmacokinetics will be evaluated on day 1 and day 14 in subjects receiving BID dosing. This open-label study will be a preface to a large double-blind placebo controlled study of ropanicant in participants with MDD."

Clinical • P2a data • CNS Disorders • Depression • Major Depressive Disorder • Mood Disorders • Psychiatry • Suicidal Ideation

Safety, Tolerability, and Pharmacokinetics of Ropanicant (SUVN-911), a Novel Alpha4 Beta2 Nicotinic Acetylcholine Receptor (α4β2 nAChR) Antagonist, in Healthy Adult and Elderly Subjects. (PubMed, Clin Drug Investig) - P1 | "Ropanicant was found to be safe and well tolerated following single and multiple oral administrations in healthy subjects. Ropanicant showed nonlinear pharmacokinetics and accumulation following multiple dosing. Urinary excretion represents an insignificant elimination pathway for ropanicant. Ropanicant pharmacokinetics were sex dependent, and food and age had no effect on its pharmacokinetics."

Clinical • Journal • PK/PD data • CNS Disorders • Depression • Major Depressive Disorder • Mood Disorders • Pain • Psychiatry

Ropanicant (SUVN-911), an α4β2 nicotinic acetylcholine receptor antagonist intended for the treatment of depressive disorders: pharmacological, behavioral, and neurochemical characterization. (PubMed, Psychopharmacology (Berl)) - "Preclinical studies with Ropanicant support the likelihood of its therapeutic utility in the treatment of depressive disorders."

Journal • CNS Disorders • Depression • Mood Disorders • Psychiatry • Sexual Disorders • BDNF

Ropanicant (SUVN-911): An orally active neuronal nicotinic acetylcholine α4β2 receptor antagonist for the management of depression (Neuroscience 2021) - "Changes were observed in calcium binding adaptor molecules (Iba1) as well. From the above studies, we conclude that ropanicant may have potential in addressing depression."

CNS Disorders • Depression • Mood Disorders • Psychiatry • Sleep Disorder • Suicidal Ideation • BDNF

Discovery and Development of 3-(6-Chloropyridine-3-yloxymethyl)-2-azabicyclo[3.1.0]hexane hydrochloride (SUVN-911): A Novel, Potent, Selective and Orally Active Neuronal Nicotinic Acetylcholine α4β2 Receptor Antagonist for the Treatment of Depression. (PubMed, J Med Chem) - "It is devoid of cardiovascular and gastrointestinal side effects. Successful long term safety studies in animals and Phase-1 evaluation in healthy humans for safety, tolerability and pharmacokinetics paved the way for its further development."

Journal • Cardiovascular • CNS Disorders • Depression • Gastrointestinal Disorder • Mood Disorders

SUVN-911(nAChR α4β2 ) antagonist addresses most of the limitations of current antidepressant therapies (Neuroscience 2017) - "The pharmacology, pharmacokinetic, metabolic, biopharmaceutical and toxicity profiles provide strong support to develop SUVN-911 for the management of major depressive disorders. Currently, a single-center, double-blind, placebo-controlled, randomized, phase 1 study to evaluate the safety, tolerability, and pharmacokinetics of SUVN-911 after single ascending doses and multiple ascending doses in healthy male subjects, under US IND is in progress."

HEOR • CNS Disorders • Depression

SUVN-911 (potent and selective nicotitinicacetylcholine α4β2 receptor antagonist) - Safety, tolerability and pharmacokinetics in healthy subjects (Neuroscience 2018) - "During multiple ascending dose studies, SUVN-911 achieved the projected efficacy concentrations. Additional Phase 1 clinical study (US IND) to evaluate the effect of food, gender and age on human pharmacokinetics is in progress. "

Clinical • PK/PD data • CNS Disorders • Depression • Mood Disorders • Psychiatry