Serotonin 1A Receptor Agonist Market: Competitive Landscape, Pipeline, and Market Analysis 2024 

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The serotonin 1A receptor or 5-HT1A receptor is a subtype of serotonin receptors or 5-HT receptors, that binds serotonin neurotransmitter, also known as 5-HT. 5-HT1A is expressed in the brain, spleen, and neonatal kidney. It is a G protein-coupled receptor (GPCR), coupled to the Gi protein, and its activation in the brain mediates hyperpolarisation and reduction of the firing rate of the postsynaptic neuron. Mechanism of action (MOA) of Serotonin 1A Receptor Agonist is by decreasing blood pressure and heart rate via a central mechanism, by inducing peripheral vasodilation, and by stimulating the vagus nerve. These effects are the result of activation of 5-HT1A receptors within the rostral ventrolateral medulla. Serotonin 1A Receptor Agonists are used to treat CNS disorders, movement disorders, epilepsy, schizophrenia, acute coronary syndrome, ischemia, obesity, Parkinson's disorder, etc.

Increased prevalence of neurological disorders and changing lifestyles are the key drivers for the Serotonin 1A Receptor Agonist market. For instance, according to the World Health Organization 2023, an estimated 3.8% of the population experience depression, including 5% of adults (4% among men and 6% among women) and 5.7% of adults older than 60 years. approximately 280 million people in the world have depression. Depression is about 50% more common among women than among men. Worldwide, more than 10% of pregnant women and women who have just given birth experience depression. Launch of newer products by the market players could seek opportunities that influence extensive research and development in Serotonin 1A Receptor Agonist. For instance, Takeda’s Trintellix (Vortioxetine) is used to treat major depressive disorder in adults. Moreover, the development of novel molecules by market players is coming up to overcome challenges in therapy. For instance, AbbVie’s Pardoprunox (SLV-308) for the treatment of Parkinson's is under the various stages of clinical studies.

Serotonin 1A Receptor Agonist Market Key Developments:
  • In July 2018, Alkermes received FDA approval for an Aristada Initio (Aripiprazole Lauroxil) for the treatment of depression and depressed state.
  • In September 2019, Takeda received MHLW approval for a Trintellix (Vortioxetine) for the treatment of schizophrenia in adults.
Approved Drug Molecules and Brand Names for Serotonin 1A Receptor Agonist:
  • Trintellix (Vortioxetine)
  • Addyi (Flibanserin)
  • Aristada (Aripiprazole lauroxil once a month)
  • Sediel (Tandospirone)
  • Aristada Initio (Aripiprazole Lauroxil Nanocrystal Dispersion)
  • Aristada LAI 6-week
Drugs under the Pipeline for Serotonin 1A Receptor Agonist:
  • Ulotaront (SEP-363856)
  • Pardoprunox (SLV-308)
  • Sarizotan (EMD128130)
  • Befiradol (NLX-112)
  • Buspirone/Zolmitriptan (JM-010)
  • Piromelatine (Neu P11)
  • Eltoprazine (DU 28853)
  • Naluzotan (PRX-00023)
  • F17464
  • Tpn-672
  • Piclozotan (SUN N4057)
  • Dsp-9632p
  • Exxua (Gepirone ER)
  • Lurasidone Injection Suspension (DSP-1349M)

Clinical Activity and Developments of Serotonin 1A Receptor Agonist:

Till June 2023, more than 20 companies have approximately 23 molecules targeting the 31 diseases. For these molecules, more than 54 clinical trials are being conducted and the majority are in phase-2 and phase-3 clinical trials by the players across the globe. For instance,

  • In January 2020, Sumitomo Pharma completed phase 4, a multicenter, randomized, usual dose-controlled study for evaluating the associated factors and predictive values of clinical outcomes of different tandospirone doses in patients with a generalized anxiety disorder of
  • In April 2023, Lundbeck completed phase 3, long-term, open-label, flexible-dose, extension study for evaluating the safety and tolerability of Vortioxetine (LuAA21004) in patients with major depressive disorder.

Molecule Name

Number of Studies

Ulotaront (SEP-363856)

26

Pardoprunox (SLV-308)

11

Sarizotan (EMD128130)

8

Befiradol (NLX-112)

6

Buspirone/Zolmitriptan (JM-010)

4

Target Indication Analysis of Serotonin 1A Receptor Agonist

Molecules such as Trintellix (Vortioxetine) were developed by Lundbeck and Takeda for the line of treatment to treat depression in adults. Sprout Pharma’s Addyi (Fibanserin) is used for the treatment of hypoactive (low) sexual desire disorder (HSDD) in women who have not gone through menopause. Alkermes Aristada (Aripiprazole lauroxil) is used for the treatment of schizophrenia. Sumitomo Pharma’s Sediel (Tandospirone) is used in the treatment of anxiety disorders, especially generalized anxiety disorder.

Key Features of the Reports

  • The report provides granular level information about the market size, regional market share, historic market (2019-2023), and forecast (2024-2030)
  • The report covers in-detail insights about the competitor’s overview, company share analysis, key market developments, and their key strategies
  • The report outlines drivers, restraints, unmet needs, and trends that are currently affecting the market
  • The report tracks recent innovations, key developments, and start-up details that are actively working in the market
  • The report provides a plethora of information about market entry strategies, regulatory framework, and reimbursement scenario

Frequently Asked Questions

Trintellix (Vortioxetine), Addyi (Flibanserin), Aristada (Aripiprazole lauroxil) are the few FDA-approved Serotonin 1A Receptor Agonist.

Sales of Trintellix (Vortioxetine) by Lundbeck were US$ 630.91 million in the FY2022 with 21% growth from FY2021.

Major market players include Takeda, Lundbeck, Sprout Pharma, Sumitomo Pharma, and Alkermis are a few leading market players.

Major Indications for Serotonin 1A Receptor agonists are to treat CNS disorders, movement disorders, epilepsy, schizophrenia, acute coronary syndrome, ischemia, etc.

There are a total of 14 molecules that are in Phase-1, Phase-2, and Phase-3 clinical development.

  • Takeda
  • Lundbeck
  • Sprout Pharma
  • Sumitomo Pharma
  • Pfizer
  • Alkermes
  • Newron
  • Daiichi Sankyo
  • Pierre Fabre

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