Drugs / Arginine
Arginine
also known as
Arginine hydrochloride · L-arginine · L-arginine hydrochloride · arginine sodium succinate · R-Gene 10
Regulatory milestones approvals, filings & regulatory actions · 2 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Approved | EU (EMA) | LysaKare | — | 2019-07-25 | europa.eu ↗ |
| Approved | US (FDA) | R-GENE 10 | — | 1973-02-28 | fda.gov ↗ |
Trials 27
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 13 trials | ||||||
| Phase 1 | NCT03478358 | Apr 2017 → Dec 2022 | neuroendocrine neoplasm | Peking Union Medical College Hospital | Unknown | No outcome recorded |
| Phase 1 | NCT03028285 | Jul 2016 → Jan 2017 | peripheral vascular disease | POLYSAN Scientific & Technological Pharmaceutical Company | Completed | No outcome recorded |
| Phase 1 | NCT02017249 | Mar 2014 → Sep 2015 | glioblastoma | Inova Health Care Services | Completed | No outcome recorded |
| Phase 1/22 trials | ||||||
| Phase 1/2 | NCT02447874 | May 2015 → Jul 2026 overdue | sickle cell disease | Emory University | Recruiting | No outcome recorded |
| Phase 1/2 | NCT00147368 | Feb 2005 → Apr 2006 | Plasmodium falciparum malaria | Menzies School of Health Research | Completed | No outcome recorded |
| Phase 210 trials · 1 missed | ||||||
| Phase 2 | NCT07466758 | Oct 2024 → Mar 2026 | muscular atrophy | Biruni University | Completed | No outcome recorded |
| Phase 2 | NCT04750902 | Jan 2021 → Feb 2024 | dental caries | Colgate Palmolive | Completed | No outcome recorded |
| Phase 2 | NCT02882373 | Oct 2018 → May 2019 | hypertensive disorder, proteinuria | M.D. Anderson Cancer Center | Withdrawn | No outcome recorded |
| Phase 2 | NCT03580122 | Dec 2017 → Jan 2018 | classic galactosemia | Maastricht University Medical Center | Completed | No outcome recorded |
| Phase 2 | NCT02388178 | Apr → Jul 2015 | dental caries | Colgate Palmolive | Withdrawn | No outcome recorded Stop: Business |
| Phase 2 | NCT01607879 | Mar 2014 → Jul 2018 | prostate cancer | Medical College of Wisconsin | Completed | Missed primary |
| Phase 2 | NCT00345605 | Feb 2008 → May 2011 | argininosuccinic aciduria | Brendan Lee | Completed | No outcome recorded |
| Phase 2 | NCT00200746 | Apr 2006 → Jul 2009 | alcoholic hepatitis | National Center for Complementary and Integrative Health (NCCIH) | Withdrawn | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT00029731 | Aug 2001 → Jul 2005 | pneumonia, sickle cell disease | UCSF Benioff Children's Hospital Oakland | Completed | No outcome recorded |
| Phase 2 | NCT01796678 | Sep 2000 → Jun 2007 | — | UCSF Benioff Children's Hospital Oakland | Completed | No outcome recorded |
| Phase 39 trials | ||||||
| Phase 3 | NCT07664592 | Jun → Jul 2026 overdue | dentin sensitivity | Colgate Palmolive | Recruiting | No outcome recorded |
| Phase 3 | NCT07257042 | Jul → Nov 2025 | hypersensitivity reaction disease | Colgate Palmolive | Completed | No outcome recorded |
| Phase 3 | NCT04839354 | Jun 2021 → Jul 2024 | sickle cell disease | Claudia R. Morris | Completed | No outcome recorded |
| Phase 3 | NCT03940053 | May 2019 → Aug 2024 | cancer | Zujiang YU | Unknown | No outcome recorded |
| Phase 3 | NCT05560945 | Apr 2019 → Mar 2022 | dental caries | Colgate Palmolive | Completed | No outcome recorded |
| Phase 3 | NCT03950518 | Apr 2019 → Apr 2023 | hepatocellular carcinoma | The First Affiliated Hospital of Zhengzhou University | Unknown | No outcome recorded |
| Phase 3 | NCT03278444 | Jul 2017 → Jul 2021 | hepatocellular carcinoma | The First Affiliated Hospital of Zhengzhou University | Unknown | No outcome recorded |
| Phase 3 | NCT03274427 | Jul 2017 → Jul 2021 | hepatocellular carcinoma | The First Affiliated Hospital of Zhengzhou University | Unknown | No outcome recorded |
| Phase 3 | NCT02829879 | Dec 2015 → Sep 2016 | dentin sensitivity | University of Chile | Unknown | No outcome recorded |
| Phase 41 trial | ||||||
| Phase 4 | NCT00569465 | Jan 2005 → Jan 2006 | essential hypertension, type 2 diabetes mellitus | University of Turin, Italy | Terminated | No outcome recorded |
| Phase not applicable2 trials | ||||||
| — | NCT05412160 | Jan 2023 → Dec 2024 | arginase deficiency, chronic obstructive pulmonary disease | University of Milan | Completed | No outcome recorded |
| — | NCT03143023 | Jun → Dec 2017 | dental caries | Cairo University | Unknown | No outcome recorded |
| Comparator or background therapy16 trials | ||||||
| Phase 1 | NCT06273930 Comparator | Feb → Oct 2024 | dentin sensitivity | Armed Forces Institute of Dentistry, Pakistan | Unknown | No outcome recorded |
| Phase 1 | NCT02440061 Comparator | May 2018 → Jun 2019 | type 2 diabetes mellitus | Jenny Tong, MD, MPH | Withdrawn | No outcome recorded |
| Phase 1 | NCT01710371 Background | Dec 2012 → Sep 2015 | type 2 diabetes mellitus | Avid Radiopharmaceuticals | Completed | No outcome recorded |
| Phase 1/2 | NCT07167693 Comparator | Dec 2025 → Oct 2027 expected | diabetic ketoacidosis, hyperglycemia | David K Carroll | Recruiting | No outcome recorded |
| Phase 2 | NCT05855330 Comparator | Jan 2024 → Jun 2028 expected | COVID-19 | Emory University | Recruiting | No outcome recorded |
| Phase 2 | NCT03273712 Background | Sep 2017 → May 2020 | medulloblastoma, meningioma, neuroblastoma, neuroendocrine neoplasm | University of Iowa | Completed | No outcome recorded |
| Phase 2 | NCT03013387 Background | Jan 2017 → Oct 2018 | medulloblastoma, meningioma, neuroblastoma, neuroendocrine neoplasm | Sue O'Dorisio | Withdrawn | No outcome recorded |
| Phase 2 | NCT00616304 Comparator | Feb 2008 → Mar 2009 | Plasmodium falciparum malaria | Menzies School of Health Research | Suspended | No outcome recorded |
| Phase 2 | NCT00513617 Comparator | Jun 2004 → Sep 2007 | sickle cell disease | UCSF Benioff Children's Hospital Oakland | Completed | No outcome recorded |
| Phase 3 | NCT04249336 Comparator | Sep 2019 → Jan 2021 | dentin sensitivity | Dow University of Health Sciences | Completed | No outcome recorded |
| Phase 3 | NCT03177109 Comparator | May 2017 → Dec 2018 | dentin sensitivity | Aga Khan University | Unknown | No outcome recorded |
| Phase 4 | NCT00720902 Comparator | Feb 2007 → Mar 2010 | pituitary deficiency | Columbia University | Terminated | No outcome recorded Stop: Enrollment |
| — | NCT06483737 Background | Jun 2025 → Jun 2027 expected | hepatic encephalopathy | General Hospital of Shenyang Military Region | Recruiting | No outcome recorded |
| — | NCT01085981 Comparator | Apr → Jun 2010 | sexual disorder | East Suburban Ob Gyn | Unknown | No outcome recorded |
| — | NCT01414530 Comparator | Apr 2010 → Jun 2014 | premature menopause | Samsung Medical Center | Unknown | No outcome recorded |
| — | NCT00280085 Background | Dec 2005 → Jul 2007 | diabetes mellitus | Pfizer | Terminated | No outcome recorded |
Evidence & citations 8 cited values
Every value below carries the sentence it was read from. 44 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Arginine | “Arginine is a nutritional supplement that may control side effects of anti-cancer drugs such as high blood pressure and protein in the urine and may also help to improve kidney...” NCT02882373 ↗35“The intervention includes a personalised pharmaconutrition formula containing arginine, glutamine, and beta-hydroxy-beta-methylbutyrate (HMB).” NCT07466758 ↗ “ibuprofen 200mg/arginine 185mg twice per day for 8 weeks” NCT01414530 ↗ “Lysine and Arginine” NCT03013387 ↗ “Lysine and Arginine” NCT03273712 ↗ |
| Known as | Arginine hydrochloride | “Arginine hydrochloride injection 5g/dose; 40g/d; ivgtt; sustained medication for 24 days; drug withdrawal for 4 days.” NCT03940053 ↗5“Arginine hydrochloride injection 5g/dose; 40g/d; ivgtt; sustained medication for 24 days; drug withdrawal for 4 days.” NCT03274427 ↗ |
| Known as | arginine sodium succinate | ClinicalTrials.gov intervention name — accepted as the source's own label NCT03028285 ↗ |
| Known as | L-arginine | “Within 12 h of receiving their first dose of intravenous opioids, enrolled participants are randomized 1:1 to receive either (1) a one-time loading dose of L-arginine (200...” PMID 37587492 ↗ Aug 20231“orally supplemented arginine (L-arginine)” NCT02882373 ↗ |
| Known as | L-arginine hydrochloride | ClinicalTrials.gov intervention name — accepted as the source's own label NCT04839354 ↗ |
| Known as | R-Gene 10 | “10% Arginine Hydrochloride-R-Gene 10” NCT01710371 ↗ |
| Modality | Other / unclassified | “Arginine is a naturally occurring amino acid” NCT00200746 ↗ |
| Route | Oral | “arginine hydrochloride orally 3 times a day” NCT00029731 ↗ |