MedPath

Iloperidone

Generic Name
Iloperidone
Brand Names
Fanapt
Drug Type
Small Molecule
Chemical Formula
C24H27FN2O4
CAS Number
133454-47-4
Unique Ingredient Identifier
VPO7KJ050N
Background

Iloperidone is an atypical antipsychotic for the treatment of schizophrenia symptoms. Hoechst Marion Roussel Inc. researched the drug until May 1996. In June 1997 they gave the research rights to Titan Pharmaceuticals, who gave the worldwide development, manufacturing, and marketing rights to Novartis in August 1998. On June 9, 2004, Titan Pharmaceuticals gave the Phase III development rights to Vanda Pharmaceuticals. FDA approved on May 9, 2009.

Indication

Treatment of acute schizophrenia.

Associated Conditions
Schizophrenia

Novo Nordisk's Amycretin Shows Promising Weight Loss in Phase 1b/2a Trial

• Novo Nordisk's amycretin, a GLP-1 and amylin receptor agonist, demonstrated significant weight loss in a Phase 1b/2a trial. • Participants on the highest dose of subcutaneous amycretin (20mg) experienced an average 22% body weight loss over 36 weeks. • The safety profile of amycretin was consistent with incretin-based therapies, with mainly mild to moderate gastrointestinal adverse events. • Novo Nordisk plans further clinical development of amycretin for adults with overweight or obesity, based on these encouraging results.

Schizophrenia Market Set for Strong Growth, Driven by Novel Therapies

• The schizophrenia market is expected to grow significantly, driven by the launch of novel therapies and increased diagnosis rates. • Long-acting injectables (LAIs) are gaining traction despite higher costs, offering an alternative to oral antipsychotics. • The US dominates the schizophrenia market due to a large patient population and high drug costs. • Emerging treatments like Cobenfy, evenamide, Ingrezza, and iclepertin aim to address unmet needs in managing both positive and negative symptoms.

Vanda Pharmaceuticals Reports Revenue Increase and Advances Pipeline in Q3 2024

• Vanda Pharmaceuticals reported a 23% increase in Q3 2024 revenues, reaching $47.7 million, driven by sales of Fanapt, HETLIOZ, and PONVORY. • The company is advancing its psychiatry portfolio, with plans to submit an NDA for milsaperidone for schizophrenia and bipolar I disorder in early 2025. • Vanda initiated the commercial launch of PONVORY for multiple sclerosis and is exploring its use in psoriasis and ulcerative colitis with IND submissions expected in Q4 2024. • A New Drug Application for tradipitant in motion sickness is expected to be submitted in Q4 2024, building on positive clinical trial results.

Schizophrenia Clinical Trial Pipeline Boasts 60+ Drugs Under Development

• The schizophrenia treatment landscape is expanding with over 60 drugs in active development, driven by increased R&D and innovative therapies. • Key players like Sumitomo Pharma, Boehringer Ingelheim, and Reviva Pharmaceuticals are advancing novel antipsychotics and personalized medicine approaches. • Recent progress includes positive Phase III trial results for brilaroxazine and LY03020's IND approval in China, signaling potential new treatment options. • COBENFY, a first-in-class muscarinic agonist, received FDA approval, marking a significant advancement in schizophrenia treatment after 35 years.

FDA Approves Cobenfy, a Novel Schizophrenia Treatment Targeting Cholinergic Receptors

• The FDA has approved Cobenfy (xanomeline and trospium chloride) as the first new class of drug for schizophrenia in over 30 years, offering a novel approach to treatment. • Cobenfy targets muscarinic receptors, unlike traditional antipsychotics that focus on dopamine, potentially reducing side effects like weight gain and movement disorders. • Clinical trials demonstrated Cobenfy significantly reduced schizophrenia symptoms compared to placebo, marking a transformative moment in managing this challenging condition. • Expected to launch in late October, Cobenfy offers a new option for adults with schizophrenia, with ongoing studies exploring its potential in Alzheimer's psychosis and other conditions.

Vanda Pharmaceuticals Faces Challenges Despite New Drug Launches and Takeover Bids

• Vanda Pharmaceuticals' Fanapt, approved for bipolar 1 disorder, faces challenges due to competition from generic antipsychotics with established physician experience. • Tradipitant's Phase 3 trial for gastroparesis failed to meet primary endpoints, and motion sickness treatment faces competition from affordable generics like scopolamine. • Despite takeover bids, Vanda rejected offers, citing undervaluation, raising concerns about cash management and strategic direction given pipeline challenges. • Vanda's internally developed Hetlioz is experiencing revenue decline due to generic competition, impacting overall financial performance.
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