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

5-hydroxytryptamine receptor 1B, also known as the 5-HT1B receptor is a protein that in humans is encoded by the HTR1B gene. 5-HT1B receptors are widely distributed throughout the CNS with the highest concentrations found in the frontal cortex, basal ganglia, striatum, and hippocampus. The function of the 5-HT1B receptor differs depending on its location. In the frontal cortex, it is believed to act as a postsynaptic receptor inhibiting the release of dopamine. In the basal ganglia and the striatum, evidence suggests 5-HT signaling acts on an autoreceptor, inhibiting the release of serotonin and decreasing glutamatergic transmission by reducing miniature excitatory postsynaptic potential. Mechanism of action (MOA) of the Serotonin 1B Receptor Agonist is by autoreceptor feedback inhibition leads through the inhibition of adenylate cyclase, an enzyme responsible for producing the intracellular signaling molecule cyclic adenosine monophosphate (cAMP). By reducing cAMP levels, the serotonin 1B receptor agonist inhibits the release of serotonin. Serotonin 1B Receptor Agonist is used in the treatment of CNS disorders, headache, migraine disorder, reperfusion injury, menstruation disturbances, delirium, etc. Increased prevalence of migraine and CNS disorders due to changing lifestyles, and rising aging population are the key drivers for the Serotonin 1B Receptor Agonist market. For instance, according to the Centers for Disease Control and Prevention 2023, more than 10% of people are affected by migraine worldwide. The introduction of newer products by market players may look for opportunities that have a big impact on comprehensive research and development in Serotonin 1B Receptor Agonists. For instance, GSK, Allergan in global collaboration with AbbVie launched Botox (Onabotulinumtoxin A) for the treatment of spasticity. Moreover, to address the difficulties in therapy, numerous market participants are developing innovative compounds. For instance, NeurAxon’s NXN-188 for the indication of migraine is under the various stages of clinical studies.

Serotonin 1B Receptor Agonist Market Key Developments:

• In July 2020, GSK, Allergan in global collaboration with AbbVie received FDA approval for the additional use of Botox (Onabotulinumtoxin A) for spasticity in pediatric patients 2 years of age and older, including those with lower limb spasticity caused by cerebral palsy.
• In March 2023, Satsuma Pharmaceuticals submitted a New Drug Application (NDA) to the US Food and Drug Administration (FDA) for Dihydroergotamine Intranasal (STS101).

Approved Drug Molecules and Brand Names for Serotonin 1B Receptor Agonist:

 Botox (Onabotulinumtoxin A)

Drugs under the Pipeline for Serotonin 1B Receptor Agonist:

• Zecuity (Transdermal Sumatriptan)
• Semprana (Dihydroergotamine Oral Inhalation)
• Dihydroergotamine Intranasal (STS101)
• ONZETRA Xsail (Sumatriptan Intranasal)
• Sumavel DosePro (Sumatriptan Succinate Needle-Free Subcutaneous Injection)
• Meloxicam/Rizatriptan (AXS-07)
• Zolmitriptan Intracutaneous Microneedle System (C213)
• NXN-188
• Trudhesa (Dihydroergotamine Mesylate Intranasal)
• ZEMBRACE Symtouch (Sumatriptan Succinate)
• Eltoprazine (DU 28853)
• Tosymra (Intranasal Sumatriptan)
• Zeneo Sumatriptan (Sumatriptan Needle-Free Injection)
• Promethazine/Sumatriptan (CL-H1T)
• Zolmitriptan Inhalational (CVT-427)
• Alsuma (Sumatriptan Succinate Subcutaneous Injection)
• Omexa (Sumatriptan Transmucosal)
• Dihydroergotamine (PUR3100)
• Rizatriptan/Naproxen
• Sumatriptan Succinate Transdermal (KC5010)

Clinical Activity and Developments of Serotonin 1B Receptor Agonist:

Up until July 2023, there will be about 29 companies with over 30 compounds that focus on various forms of CNS and migraine disorders. For these molecules, more than 187 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 March 2021, Satsuma Pharmaceuticals completed phase 3, a randomized, double-blind, parallel-group, placebo-controlled, multicenter study to evaluate the efficacy, safety, and tolerability of single doses of STS101 (Dihydroergotamine Nasal Powder) in the acute treatment of migraine.
• In September 2022, Axsome Therapeutics completed phase 3, a randomized, double-blind, placebo-controlled, single-dose study to evaluate the efficacy and safety of AXS-07 (Meloxicam and Rizatriptan) for the acute treatment of migraine in adults.