Purinergic receptors also known as purinoceptors are a family of plasma membrane molecules that are found in mammalian tissues. Purinergic receptors are transmembrane receptors consisting of two main categories including P1 and P2. P1 receptors are stimulated by adenosine and the receptors those respond to extracellular nucleotides (ATP, ADP, UTP and UDP) are P2 receptors. Both metabotropic receptors are distinguished by taking into account their reactivity to specific activators. They are involved in several cellular functions including the proliferation and migration of neural stem cells, vascular reactivity, apoptosis, and cytokine secretion. The molecules act on the purinoceptor are known as purinoceptor analogues and these molecules has predominant role in Respiratory diseases, CNS disorder, urinary bladder diseases, eye disorders, osteoarthritis (OA), rheumatoid arthritis, and other joint diseases. Rheumatoid arthritis (RA) is the commonest of the inflammatory arthritis. According to the Center for Disease Control and Prevention 2020, approximately 1 in 4 people are affected with rheumatoid arthritis in the USA and it estimated that approximately 78 million USA adults will affect with RA by 2040. Development and launch of newer products by the market players significantly enhances the revenue of purinoceptor analogues market over the forecast years. For instance, Merck, and Santen are currently providing Purinoceptor analogues for the treatment of Asthma and Eye disorders. Apart from these, Johnson & Johnson conducting 7 studies in phase-1 trial and one study in phase-2 clinical trial on JNJ-54175446 for the indication of Antidepression. Moreover, AstraZeneca’s BLU-5937 for the treatment of refractory chronic cough, Pfizer’s CE-224535 for Rheumatoid Arthritis, Eli Lilly’s LY3857210 for the osteoarthritis pain are under the various stages of clinical studies.
Key Market Developments:
In January 2022, US Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) regarding Merck’s New Drug Application (NDA) for Gefapixant, the investigational, non-narcotic, orally administered selective P2X3 receptor antagonist, under development for the treatment of refractory chronic cough (RCC) or unexplained chronic cough (UCC) in adults.
In January 2022, Japan Ministry of Health Labor and Welfare (MHLW) approved LYFNUA (Gefapixant) Tablets 45 mg for adults with refractory or unexplained chronic cough.
In August 2021, Santen Pharmaceutical Co., Ltd. filed Manufacturing and Marketing Approval of STN1008903 (diquafosol sodium) - improved formulation to reduce the frequency of administration for dry eye ophthalmic drug.
Approved Drug Molecules for Purinoceptor along with the Brand Names:
Lyfnua (Gefapixant)
Diquas (Diquafosol)
Drugs under the Pipeline for Purinoceptor:
Eliapixant (BAY 1817080) - Evotec
Camlipixant (BLU-5937) – Bellus Health
JNJ-54175446 - Johnson & Johnson
AZD9056 - AstraZeneca
CE-224535 -Pfizer
JNJ-55308942 - J&J
LY3857210 - Eli Lilly
Flapixant (BAY1902607) - Bayer, Evotec
HS-10383 - Jiangsu Hansoh Pharma
SGM-1019 - Evotec
Sivopixant (S-600918) - Shionogi
Clinical Activity and Developments of Purinoceptor Analogues molecules:
In June 2019, Bellus Health initiated the patient enrollment for BLU-5937 phase II studies for the the treatment of refractory chronic cough.
In June 2021, an earlier phase 2a study conducted in Japan for Sivopixant by Shionogi, showed a 31.6% reduction in the objective frequency of daytime cough after 2 weeks and a 30.9% reduction in frequency of cough over 24 hours.
In 2022, newly developed Sivopixant has high selectivity towards P2X3 versus P2X2/3 in Randomised trial Sivopixant for refractory chronic cough, study includes 31 randomised patients, 15 in the sivopixant-first group and 15 in the placebo-first group completed the study.
Target Indication Analysis of Purinoceptor Analogues
The molecules such as LYFNUA (gefapixant) and DIQUAS (diquafosol) developed by Merck and Santen respectively, have obtained encouraging results in clinical trials and are currently in the market for treatment of adults with refractory or unexplained chronic cough and dry eye associated with keratoconjunctival epithelium disorders that accompany lacrimal fluid abnormality in Japan, Korea, Vietnam, and Thailand. Increase in the incidence of respiratory diseases, eye disorders, osteoarthritis (OA), rheumatoid arthritis are expected to act as opportunities and also be the growth drivers for the Purinoceptor analogue market.
Regional Analysis of Purinoceptor Analogues
Purinoceptor Analogues Market
Total sales for Diquas by Santen in the FY2022 was US$ 148.68 million, while in the Japan alone the sales were US$ 115.18 million followed by China with US$ 19.64 million and Asia with US$ 13.86 million. The revenue of the Diquas was increased significantly in 2022 compared with previous year. The revenue indicates that Japan is the leading country for sell of the Diquas due to increase in the prevalence of dry eye disorder (DED) in the Japanese population was relatively high with other countries. For China and Asia, penetration of Diquas is comparatively less and branding the molecule in this region may create opportunity for the company. Increase in the incidence of ophthalmic disorders in the USA also expected to burgeon the purinoceptor analogues market in the future years. For instance, according to the American Academy of Ophthalmology, 20 million people in the United States have dry eye disease (DED) and number is growing in both young and adult population.
Latin America
Europe
Asia Pacific
Middle East
North America
Frequently Asked Questions
Lyfnua (gefapixant), Diquas (diquafosol) are the approved Purinoceptor analogues.
Sales of Diquas is US$ 148.68 million in FY2022, while in the Japan alone the sales was US$ 115.18 million followed by China US$ 19.64 million and Asia US$ 13.86 million.
Major market players include Merck & Co., Inc., Santen, AstraZeneca, Evotec, Johnson & Johnson, Pfizer, and Eli Lilly are a few leading market players.
Development of novel molecules for prostate cancer and ovarian cancer create the lucrative opportunities for the purinoceptor analogues market over the forecast years.
Major Indications for Purinoceptor analogues are Respiratory diseases, CNS disorder, urinary bladder diseases,eye disorders, osteoarthritis (OA), rheumatoid arthritis.
There are a total of 11 molecules that are in the Phase-1/Phase-2 clinical development for Purinoceptor Analogues.
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- Merck & Co., Inc. (USA)
- Santen (Japan)
- AstraZeneca (UK)
- Johnson & Johnson Services Inc. (USA)
- Pfizer Inc. (USA)
- Bellus Health Inc. (Canada)
- Bayer AG (Germany)
- Evotec AG (Germany)
- Eli Lilly and Co. (USA)
- Shionogi Inc. (Japan)