View all newsletters
Receive our newsletter - data, insights and analysis delivered to you
  1. Comment
January 18, 2022updated 21 Mar 2022 8:54am

Bipolar disorder pipeline: a mix of old and innovative agents

The bipolar disorder pipeline includes agents that target bipolar mania and bipolar depression, as well as more niche indications.

By GlobalData Healthcare

The bipolar disorder pipeline is moderate in size, with agents in a range of different drug classes. It includes both agents that target bipolar mania and agents that target bipolar depression, as well as more niche patient populations such as treatment-resistant bipolar depression. Figure 1 (above) summarises the pipeline agents in clinical development for bipolar disorder across the eight major markets (8MM), namely the US, the five major European markets (5EU – France, Germany, Italy, Spain and the UK), Japan and Canada.

Free Report
img

Spot leading innovative companies with GlobalData’s Innovation Scorecard

Innovation remains a necessity in a disruptive ecosystem, as continuous innovation allows companies to adapt, evolve, and grow through disruption. Using our in-house alternative datasets, we are excited to launch GlobalData’s Innovation Scorecard. This scorecard will allow clients to rank 3,500+ companies on their innovation activity, impact, and disruptive potential across geography, sector, and theme. The scorecard provides a data-driven framework to rank leading companies on the potential of their intellectual property (IP) portfolio. GlobalData’s Innovation Scorecard focuses not only on the activity of innovation in the organization but also on its impact and disruptive potential using the 3I framework: Intensity, Impact, and Ingenuity. The tool helps clients to identify the most innovative companies that are disruptive leaders and challengers and can create alpha for their portfolio using the insights driven by 19+ high-value KPIs. Download our report to find out more about this innovative tool. Key findings derived from this tool include:
  • Alphabet, Tencent, and Qualcomm are the top three innovative companies in the last 10 years
  • The scorecard finds Technology & Communications and Pharma & Healthcare as the two main sectors driving innovation
  • Loreal placed as ‘Disruptive Leader’ in the Consumer sector, while Revlon has been identified as a traditional laggard
  • Companies such as Etsy and H&M are challenging retail ‘Disruptive Leaders’ Amazon and Walmart
by GlobalData
Enter your details here to receive your free Report.

The atypical antipsychotics have a strong presence in the bipolar disorder pipeline, despite the presence of 13 atypical antipsychotic products, as well as generics, already being on the market for managing acute manic symptoms. Pipeline agents will therefore need to demonstrate significant advantages over currently available products to best compete in the market, a point emphasised by key opinion leaders (KOLs) interviewed by GlobalData. One way these agents can differentiate themselves is through their safety profiles, as the marketed atypical antipsychotics are associated with effects on metabolic parameters (such as weight gain, hyperglycaemia and dyslipidaemia) and extrapyramidal symptoms (dystonia, akathisia, Parkinsonism and tardive dyskinesia).

KOLs agreed that despite intense competition, space remains in the bipolar disorder market for atypical antipsychotics with significantly improved safety profiles. Even with improvements in safety, the lack of novelty in this approach means that new atypical antipsychotics are likely to result only in incremental advances in treatment efficacy, especially for products that are reformulations of existing drugs, such as risperidone extended release (ER) and aripiprazole controlled release (CR), both of which are in Phase I development.

Beyond the atypical antipsychotics, there are a variety of novel mechanisms of action (MoAs) in the bipolar disorder pipeline that developers are hoping will offer improved efficacy and safety compared with available products. These new MoAs provide a point of difference for developers looking to enter this competitive market, and they may also be used to target new patient sub-populations in which competition is lower. For example, if they reach the market, Celon Pharma’s Falkieri (esketamine) would become the first approved treatment for treatment-resistant bipolar depression, while NRX Pharmaceuticals’s Cyclurad (cycloserine + lurasidone) would become the first approved treatment for acute suicidal ideation or behaviour associated with bipolar depression. There is a high unmet need for effective treatments for bipolar depression, and suicide rates are higher in bipolar disorder patients than in the general population, so these are important patient populations to be targeting.

GlobalData anticipates that six products in the late-stage pipeline will enter the bipolar disorder market prior to 2030. These products are BioXcel Therapeutics’ dexmedetomidine, Vanda Pharmaceuticals’ Fanapt (iloperidone), Jina Pharmaceuticals’ endoxifen, Cyclurad, Sunovion Pharmaceuticals’ SEP-4199 (amisulpride), and Falkieri. In addition, Intra-Cellular Therapies’ Caplyta (lumateperone) received US Food and Drug Administration (FDA) approval for the treatment of depressive episodes associated with bipolar I or II disorder last month and is expected to launch later this year.

Although there are several promising agents in the pipeline, it is unlikely that lithium will be replaced as the gold standard treatment for bipolar disorder, given its efficacy in treating both bipolar mania and bipolar depression, as well as the fact that it is effective for both acute and maintenance therapy. It is also unlikely that these agents will alter the treatment paradigm. It is more likely that they will become supplementary options that can be added to existing treatments or used when more established therapies fail.

Related Companies

Free Report
img

Spot leading innovative companies with GlobalData’s Innovation Scorecard

Innovation remains a necessity in a disruptive ecosystem, as continuous innovation allows companies to adapt, evolve, and grow through disruption. Using our in-house alternative datasets, we are excited to launch GlobalData’s Innovation Scorecard. This scorecard will allow clients to rank 3,500+ companies on their innovation activity, impact, and disruptive potential across geography, sector, and theme. The scorecard provides a data-driven framework to rank leading companies on the potential of their intellectual property (IP) portfolio. GlobalData’s Innovation Scorecard focuses not only on the activity of innovation in the organization but also on its impact and disruptive potential using the 3I framework: Intensity, Impact, and Ingenuity. The tool helps clients to identify the most innovative companies that are disruptive leaders and challengers and can create alpha for their portfolio using the insights driven by 19+ high-value KPIs. Download our report to find out more about this innovative tool. Key findings derived from this tool include:
  • Alphabet, Tencent, and Qualcomm are the top three innovative companies in the last 10 years
  • The scorecard finds Technology & Communications and Pharma & Healthcare as the two main sectors driving innovation
  • Loreal placed as ‘Disruptive Leader’ in the Consumer sector, while Revlon has been identified as a traditional laggard
  • Companies such as Etsy and H&M are challenging retail ‘Disruptive Leaders’ Amazon and Walmart
by GlobalData
Enter your details here to receive your free Report.

NEWSLETTER Sign up Tick the boxes of the newsletters you would like to receive. Key drug pipeline and competitive landscape changes based on the latest clinical activity, sent every Tuesday. Curated analysis and data-driven insights on clinical trials strategy and operations, sent every Thursday. The pharmaceutical industry's most comprehensive news and information delivered every month.
I consent to GlobalData UK Limited collecting my details provided via this form in accordance with the Privacy Policy
SUBSCRIBED

THANK YOU

Thank you for subscribing to Clinical Trials Arena