nitrogen
Approved
Jun 23, 2013
Elemental nitrogen is a colorless, odorless, tasteless and mostly inert diatomic gas at standard conditions, constituting 78% by volume of Earth's atmosphere. Nitrogen occurs in all living organisms. It is a constituent element of amino acids and therefore of proteins and nucleic acids (DNA and RNA). Nitrogen is found in the chemical structure of almost all neurotransmitters and is a key component of alkaloids. Specific bacteria (e. g. Rhizobium trifolium) possess nitrogenase enzymes which can fix atmospheric nitrogen into a form (ammonium ion) which is chemically useful to higher organisms. Animals use nitrogen-containing amino acids from plant sources, as starting materials for all nitrogen-compound animal biochemistry, including the manufacture of proteins and nucleic acids. Animal metabolism of NO (nitric oxide) results in production of nitrite. Animal metabolism of nitrogen in proteins generally results in excretion of urea, while animal metabolism of nucleic acids results in excretion of urea and uric acid. The characteristic odor of animal flesh decay is caused by nitrogen-containing long-chain amines, such as putrescine and cadaverine. Decay of organisms and their waste products may produce small amounts of nitrate, but most decay eventually returns nitrogen content to the atmosphere, as molecular nitrogen. The circulation of nitrogen from the atmosphere through organics and then back to the atmosphere is commonly referred to as the nitrogen cycle. Nitrogen can be measured in urine with the Kjeldahl method or by spectrophotometric methods (enzymic tests). Total urinary nitrogen is calculated based on urea urinary nitrogen quantified with these methods. Liquid nitrogen (E941) is widely used in food industry as a freezing agent and as a protection against the impact of microorganisms. Nitrogen (E941) extends the period of validity of food and maintains its nutrients and is also used for packing products. In other fields of industry, nitrogen (E941) is useful in suppressing the combustion processes and in creating protective environment in order to avoid oxidation. Medical nitrogen has various medical uses, especially in liquid form when it provides temperatures as low as -196° C. Applications of medical nitrogen in the healthcare environment may include the following: * In cryopreservation for the long-term preservation of blood, blood components, other cells, body fluids or tissue samples. * In cryosurgery for minor surgical procedures in dermatology. * As a component in many gas mixtures. * As a displacement medium for sterile equipment, a non-oxidising displacement medium in pharmaceutical vials and as a propellant in pressurised aerosol dispensers. * As a source of pneumatic pressure to power gas-operated medical devices. * As a coolant for carbon dioxide surgical lasers. — NCATS
Clinical trial activity
35 trials · 44 clinical orgs · 12 marketing orgs
Earliest trial started Nov 1, 1998 (NCT00781352)
Timeline
1950s
- Jun 1, 1950
Evidence of US Marketing
1990s
- Jan 1, 1998
Earliest Phase 3 Sponsor(trial)
2010s
- Jun 23, 2013
Air Liquide — Earliest FDA Approval
- Jun 23, 2013
Air Liquide — NDA Secondary Org
- Jun 23, 2013
Air Liquide — NDA Organization
- Jul 5, 2013
Linde AG — NDA Secondary Org
- Jul 5, 2013
BOC International — NDA Secondary Org
- Jul 14, 2013
Norco — NDA Secondary Org
- Jul 16, 2013
Airgas Usa Llc — NDA Secondary Org
- Jul 21, 2013
Praxair — NDA Secondary Org
- Jul 23, 2013
Air Products And Chemicals Inc — NDA Secondary Org
- Jul 23, 2013
Aspen Air — NDA Secondary Org
- Aug 2, 2013
Matheson Tri-Gas Inc — NDA Secondary Org
- Aug 24, 2018
Universal Industrial Gases, Inc — NDA Secondary Org
- Sep 10, 2018
Cristal Therapeutics — NDA Secondary Org
2020s
- Jun 29, 2020
Air Liquide — Marketing Organization
- Jun 10, 2022
ABSOLUTE AIR, LLC — Marketing Organization
- Jun 10, 2022
ABSOLUTE AIR, LLC — NDA Secondary Org
Indications
Approved for
Studied for
- Bipolar Disorder · Early Phase 1
- Bronchopulmonary Dysplasia · Phase 2
- Burns · Phase 3
- Cardiovascular Diseases · Phase 2
- Colorectal Neoplasms · Phase 3
- Coronavirus Infections · Phase 2
- COVID-19 · Phase 2
- Cystic Fibrosis · Phase 1/Phase 2
- Endothelial Cells · Phase 2
- Healthy Volunteers · Phase 1
- Heart Failure · Phase 2
- Heart Valve Diseases · Phase 1/Phase 2
- Hypertrophy, Left Ventricular · Phase 2
- Hypoxia · Phase 3
- Liver Diseases · Phase 4
- Lung Diseases · Phase 3
- Major Depressive Disorder · Early Phase 1
- Neoplasms · Phase 4
- Obsessive-Compulsive Disorder · Phase 2
- Out-of-Hospital Cardiac Arrest · Phase 2
- Oxidative Stress · Phase 2
- Pain · Phase 4
- Persistent Fetal Circulation Syndrome · Phase 4
- Pulmonary Disease, Chronic Obstructive · Phase 2
- Pulmonary Embolism · Phase 2
- Reperfusion Injury · Phase 2/Phase 3
- Respiratory Insufficiency · Phase 3
- Respiratory Tract Infections · Phase 2
- Retinal Diseases · Phase 4
- Stress Disorders, Post-Traumatic · Phase 2
- Tinea · Phase 2
Mechanism of action
- Unspecified targetRadiopharmaceutical
radiopharmaceutical
Approval history
- approvedJun 23, 2013
- approvedJun 1, 1950
Chemistry & pharmacology
SMILES
N#N- Mol. weight
- 28.0134 g/mol
- Lipinski Ro5
- Pass
- Rule of 3
- Yes
- Chirality
- Achiral Molecule
- Inorganic
- No
- Polymer
- No
- Delivery
- Topical
- Availability
- Prescription Only
Oral
No
Parenteral
No
Topical
Yes
Sources
- WikipediaNitrogen ↗
- NCATSN762921K75 ↗
- ChEMBLCHEMBL142438 ↗
Also known as
- e941
- e941
- molecular nitrogen
- nitrogen
- nitrogen
- nitrogen
- nitrogen
- nitrogen
- nitrogen
- nitrogen
- nitrogen
- nitrogen
- nitrogen
- nitrogen
- nitrogen gas
- nitrogen, nf
Clinical trials
| NCT ID | Phase | Start date | Sponsor(s) |
|---|---|---|---|
| NCT07263399 | N/A | Jan 31, 2026 | Blekinge Institute of Technology, Karolinska Institute, Lund University, University of Gothenburg |
| NCT05873335 | N/A | Feb 28, 2023 | Gabi SmartCare, University of California, San Francisco |
| NCT04528771 | Phase 1 | Oct 31, 2020 | Case Western Reserve University |
| NCT04378426 | Phase 2 | Sep 1, 2020 | Department of Veteran Affairs |
| NCT04398290 | Phase 2 | Jul 1, 2020 | Bellerophon Therapeutics, University of Miami |
| NCT04134754 | N/A | Oct 31, 2019 | University of Iowa |
| NCT03826693 | Phase 2 | Sep 30, 2019 | Brain & Behavior Research Foundation, Stanford University |
| NCT03978338 | N/A | Jul 31, 2019 | Chinese Academy of Medical Sciences, Zhitong Biopharma CO.,LTD |
| NCT04022161 | Phase 2 | Jul 25, 2019 | Harvard University, Moorgreen Hospital, Southampton |
| NCT03748446 | Early Phase 1 (Phase 1) | Dec 15, 2018 | Harvard University |
| NCT03331445 | Phase 2 | Oct 24, 2017 | Albert Einstein Israelite Hospital, Mallinckrodt, Nitric Solutions Inc. |
| NCT03079102 | Phase 2 | Jul 1, 2017 | Mallinckrodt, University of Pittsburgh |
| NCT02860975 | Phase 1 | Jan 1, 2017 | Harvard University |
| NCT02572557 | N/A | Dec 1, 2016 | University of Groningen |
| NCT01891500 | Phase 4 | May 1, 2016 | Mallinckrodt, University of Florida |
| NCT01939301 | Phase 2 | Oct 1, 2013 | Indiana University, Mallinckrodt, National Heart, Lung, and Blood Institute (NHLBI), National Institutes of Health (NIH), The University of Texas, Dallas, University of Mississippi |
| NCT01925482 | N/A | Sep 1, 2013 | National Institute on Deafness and Other Communication Disorders (NIDCD), University of Pittsburgh |
| NCT01802619 | Phase 1/Phase 2 (Phase 2) | Aug 31, 2013 | Xijing Hospital |
| NCT01692821 | Phase 4 | Jun 1, 2012 | University of Vienna |
| NCT01220687 | N/A | Apr 1, 2011 | Mallinckrodt, University of Oklahoma |
Organizations
Research & Development (44)
Marketing (19)
| Organization | Org type | Relationship | Date |
|---|---|---|---|
| ABSOLUTE AIR, LLC | For profit | MKTG | Jun 10, 2022 |
| ABSOLUTE AIR, LLC | For profit | NDA2 | Jun 10, 2022 |
| Air Liquide | For profit | SYN | Jul 13, 2013 |
| Air Liquide | For profit | NDA2 | Jun 23, 2013 |
| Air Liquide | For profit | MKTG | Jun 29, 2020 |
| Air Liquide | For profit | NDA | Jun 23, 2013 |
| Air Products And Chemicals Inc | For profit | NDA2 | Jul 23, 2013 |
| Airgas Usa Llc | For profit | NDA2 | Jul 16, 2013 |
| Airgas Usa Llc | For profit | SYN | Sep 7, 2013 |
| Aspen Air | For profit | NDA2 | Jul 23, 2013 |
| BOC International | For profit | NDA2 | Jul 5, 2013 |
| Cristal Therapeutics | For profit | NDA2 | Sep 10, 2018 |
| Linde AG | For profit | SYN | Jul 5, 2013 |
| Linde AG | For profit | NDA2 | Jul 5, 2013 |
| Matheson Tri-Gas Inc | For profit | NDA2 | Aug 2, 2013 |
| Norco | For profit | NDA2 | Jul 14, 2013 |
| Praxair | For profit | SYN | Aug 27, 2013 |
| Praxair | For profit | NDA2 | Jul 21, 2013 |
| Universal Industrial Gases, Inc | For profit | NDA2 | Aug 24, 2018 |