Nitric Oxide Donors Market: Competitive Landscape, Pipeline, and Market Analysis 2023

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Nitrous oxide (NO) is a ubiquitous signaling molecule and is present virtually in all tissues in the human body and plays a vital role in many physiological processes like regulating vessel homeostasis, prevention of thrombosis, role in platelet activation, inflammatory processes, and wound healing processes. NO released by the body is responsible for making the penis erect during sexual intercourse. Also, before childbirth, NO released by the infant’s vessels is responsible for preventing the closure of the ductus arteriosus. NO is produced endogenously using L-arginine in the wall of the blood vessels as a substrate of low concentration by the enzyme NO synthases.  Dysfunctions in NO production and regulation have also been associated with chronic lung infections, especially in cystic fibrosis (CF) patients, wound infections, vascular diseases like ischaemic heart diseases, angina pectoris, hypertension, etc. Moreover, NO released in the eyes has a role to play in draining out the aqueous humor facilitated by PGFplays a significant role in the pathophysiology of Glaucoma. Companies are trying to find new and novel molecules to prevent and cure these diseases. The development and launch of newer products by the market players will significantly enhance the revenue of the Nitric Oxide Donors market over the forecast years. For instance, according to a research article, angina is the most common symptom of ischaemic heart disease, and approximately 9 million in 2022 in the USA have symptoms of angina.

A number of these inhibitors are in the market while many are in ongoing clinical trials. 22 companies have various products in their pipelines with 21 products in various stages of clinical trials. 2 products are in Phase 4, 4 products are in Phase 3, 13 products are in Phase 2 and 1 product is in Phase 1 of the clinical trials.

Approved molecules

  • Rectiv (nitroglycerin)
  • BiDil (hydralazine isosorbide dinitrate)

Drugs in Pipeline

  • Vascana (nitroglycerin)
  • cimlanod (BMS986231)
  • B244 topical
  • sodium nitrite inhalation (AIR001)
  • sodium nitrite
  • sodium nitrite (RESP301)
  • PDNO
  • Thiolanox (nitric oxide)
  • nitric oxide (NO)?donating bimatoprost analog (NCX 470)
  • sodium nitrite oral (TV 1001)
  • B244 nasal
  • CXL -1020
  • sodium nitrite slow-release oral (JAN101)
  • Genosyl DS (nitric oxide inhalation)
  • NOviricid (sodium nitrite lozenge)
  • SB208
  • VVN539
  • memantine nitrate (MN-08)

Clinical Activity and Developments of Nitric Oxide Donors

As of June 2023, 22 companies have approximately 21 products for 104 diseases. For these diseases, more than 19 trials are being conducted by the players globally. For instance,

  • In November 2020, Cairo University completed a Phase 3 trial to study the effect of isosorbide mononitrate in reducing pain during Cooper intrauterine device insertion. 

Molecule name

Number of studies

Vascana (nitroglycerin)

10

cimlanod (BMS986231)

10

Rectiv (nitroglycerin)

8

B244 topical

7

BiDil (hydralazine isosorbide dinitrate)

5

Target Indication Analysis of Nitric Oxide Donors

Drugs like Rectiv (nitroglycerin) and BiDil (hydralazine and isosorbide dinitrate) are commercially available NO donors are used in the treatment of various indications like Angina Pectoris and Ischaemic Heart Diseases. NO donors are used in many other indications like treating Erectile Dysfunction (ED), Pulmonary Arterial Hypertension (PAH), Pulmonary Hypertension in newborns, and others. However, the most use of NO donors is for the treatment of angina pectoris as a vasodilator. According to the Department of Health, every year, about 697,000 people die because of heart disease in the USA, wherein 382,820 deaths are due to coronary heart disease (CAD).

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

Rectiv (nitroglycerin), BiDil (hydralazine/isosorbide dinitrate), Glytrin (Glyceryl Trinitrate) are some of the Nitric Oxide Donors approved by the FDA.

These are being used in various indications like Coronary Artery Disease (CAD), Pulmonary Hypertension (PH), Angina Pectoris, Erectile dysfunction and others

MediQuestpharma (USA), BMS (USA), Kyowa Kirin Co., Ltd (Japan), Endo Pharmaceuticals Inc. (USA) and AOBiome (USA) are some of the major market players for Nitric Oxide Donors.

Rising incidence of diseases, improvement in technologies, development of new treatment lines in the market and changing lifestyles leading to cardiovascular and ophthalmic disorders are the key opportunities for Nitric Oxide Donors in the market.

  • MediQuestpharma (USA)
  • BMS (USA)
  • Kyowa Kirin Co., Ltd (Japan)
  • Endo Pharmaceuticals Inc. (USA)
  • AOBiome (USA)
  • Savara Inc. (USA)
  • Arbor Pharmaceuticals LLC (USA)
  • Hope Pharmaceuticals Ltd. (UK)
  • 30 Technology (UK)
  • Attgeno (Sweden)
  • Tracxn Technologies Ltd. (India)
  • Nicox (France)
  • TheraVasc (USA)
  • JanOne (USA)
  • Vero Biotech Ltd. (India)
  • Nitric Oxide Innovations LLC
  • Novan (USA)
  • VivaVision Biotech (China)
  • Magpie Pharmaceutical Co., Ltd. (China)

Adjacent Markets