L-arginine
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 74 · started per year
Also used as a comparator or background therapy in 34 trials
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 13 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| Phase 1 | NCT02440061 Comparator | May 2018 → Jun 2019 | type 2 diabetes mellitus | Jenny Tong, MD, MPH | Withdrawn | No outcome recorded |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 1/21 trial | ||||||
| Phase 1/2 | NCT07167693 Comparator | Dec 2025 → Oct 2027 expected | diabetic ketoacidosis, hyperglycemia | David K Carroll | Recruiting | No outcome recorded |
| Phase 29 trials | ||||||
| Phase 2 | NCT07394270 Comparator | Feb 2026 → Mar 2027 expected | heart failure | German University in Cairo | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07135037 Comparator | Sep 2024 → Sep 2025 overdue | oligohydramnios | Kafrelsheikh University | 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| Jan 2017 → Oct 2018 | medulloblastoma, meningioma, neuroblastoma, neuroendocrine neoplasm | Sue O'Dorisio | Withdrawn | No outcome recorded |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 | NCT01841281 Comparator | Aug 2013 → Aug 2018 | asthma | Nicholas Kenyon | Completed | 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 | NCT00280683 Comparator | Dec 2004 → Nov 2008 | asthma | University of California, Davis | Completed | 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 36 trials | ||||||
| Phase 3 | NCT06044194 Comparator | Mar 2023 → Sep 2024 | heart failure | Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico | Unknown | No outcome recorded |
| Phase 3 | NCT05470998 Comparator | Jul 2022 → Oct 2024 | sickle cell disease | Tanta University | 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 3 | NCT00677339 Comparator | Jun 2008 → Feb 2010 | pulmonary tuberculosis | Menzies School of Health Research | Completed | No outcome recorded |
| Phase 3 | NCT00917449 Comparator | Dec 2005 → Jun 2009 | glucose intolerance, metabolic syndrome X | IRCCS San Raffaele | Completed | No outcome recorded |
| Phase 48 trials | ||||||
| Phase 4 | NCT06753526 Comparator | Jul 2023 → Apr 2024 | ureterolithiasis | Sohag University | Completed | No outcome recorded |
| Phase 4 | NCT04626375 Comparator | Sep 2020 → Aug 2021 | myocardial disorder | Federico II University | Completed | No outcome recorded |
| Phase 4 | NCT04643600 Comparator | Mar 2019 → Feb 2022 | — | Goranka Radmilović | Unknown | No outcome recorded |
| Phase 4 | NCT03402191 Comparator | Jul 2016 → Dec 2023 | thalassemia | Tanta University | Unknown | No outcome recorded |
| Phase 4 | NCT01038622 Comparator | Nov 2009 → Nov 2010 | — | Assistance Publique - Hôpitaux de Paris | Completed | No outcome recorded |
| Phase 4 | NCT00720902 Comparator | Feb 2007 → Mar 2010 | pituitary deficiency | Columbia University | Terminated | No outcome recorded |
| Phase 4 | NCT02117206 Comparator | Nov 2005 → Mar 2012 | limb ischemia, mitochondrial disease | University Hospital, Strasbourg, France | Completed | No outcome recorded |
| Phase 4 | NCT00777075 Comparator | Jul 2003 → Nov 2005 | erectile dysfunction | Hannover Medical School | Completed | No outcome recorded |
| Phase not applicable7 trials | ||||||
| — | NCT06483737 Background | Jun 2025 → Jun 2027 expected | hepatic encephalopathy | General Hospital of Shenyang Military Region | Recruiting | No outcome recorded |
| — | NCT03834610 Comparator | Oct 2017 → Oct 2018 | erectile dysfunction | Aswan University Hospital | Completed | 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 |
| — | NCT00718510 Comparator | Sep 2009 → Jul 2011 | schizophrenia | University of Alberta | Completed | No outcome recorded |
| — | NCT00280085 Background | Dec 2005 → Jul 2007 | diabetes mellitus | Pfizer | Terminated | No outcome recorded |
| — | NCT00603720 Comparator | Sep 2005 → Jun 2008 | cardiovascular disorder | Washington University School of Medicine | Completed | No outcome recorded |
Evidence & citations 13 cited values
Every value below carries the sentence it was read from. 113 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| 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 202372“L-Arginine is an amino acid that plays a role in a number of metabolic pathways and serves as a substrate for NOS (Nitric Oxide synthase) enzyme which is essentially involved...” NCT05653895 ↗ “This daily intervention over 3 months combines 4 g L-serine, 14 g L-glutamine, 3 g L-arginine, 2.5 g N-acetylcysteine, 5.75 g L-citrulline, 1 g vitamin C, and 5 g creatine to...” NCT06967428 ↗ “Pharmacokinetic (PK) study of L-arginine after exaggerated oral use of the novel dentifrice product COL101 after repeated daily applications in healthy adult subjects.” NCT06182267 ↗ “Patients were randomly assigned to receive L-arginine (goal dose of 3 g 3 times a day) or matching placebo for 6 months.” PMID 16391217 ↗ Jan 2006 “After double-blind randomization, patients received either 14 g/day of L-arginine, or a placebo.” PMID 19359073 ↗ Apr 2009 “Group (1) was given daily 3 g(three divided doses) oral tablets of L-arginine for eight weeks.” NCT06947265 ↗ “the patient takes 1 tbl of L - Arginine 500 mg on mouth to an empty stomach” NCT04643600 ↗ “L-glutamine, L-arginine and calcium beta-hydroxy-beta-methylbutyrate” NCT04701463 ↗ “receive L-arginine 3g + l-Citruline 2 g PO, for 24 h, until birth.” NCT05029778 ↗ “L-arginine supplementation for the treatment of pre-eclampsia” NCT00275158 ↗ “L-arginine 3 gm sachets are used twice daily” NCT07394270 ↗ “orally supplemented arginine (L-arginine)” NCT02882373 ↗ “L-Arginine L-Arginine 1 g po TID” NCT04813471 ↗ “Drug: l-arginine” NCT01263041 ↗ |
| 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” NCT03273712 ↗ “Lysine and Arginine” NCT03013387 ↗ |
| Known as | Arginine hydrochloride | “Arginine hydrochloride injection 5g/dose; 40g/d; ivgtt; sustained medication for 24 days; drug withdrawal for 4 days.” NCT03274427 ↗5“Arginine hydrochloride injection 5g/dose; 40g/d; ivgtt; sustained medication for 24 days; drug withdrawal for 4 days.” NCT03940053 ↗ |
| Known as | arginine sodium succinate | ClinicalTrials.gov intervention name — accepted as the source's own label NCT03028285 ↗ |
| Known as | Bioarginine | ClinicalTrials.gov intervention name — accepted as the source's own label NCT04626375 ↗ |
| Known as | L-arg | “We ran a prospective pilot in 3 MELAS sibs (m.3243A>G tRNALeu(UUR)) with variable % mutant blood mtDNA to assess effects of L-Arginine (L-Arg) (single dose and 6-wk...” PMID 32881886 ↗ Sep 20202“Objective: To evaluate whether variants of the eNOS gene are associated with endothelial and metabolic responses to L-arginine (L-arg) supplementation.” PMID 26385052 ↗ Aug 2015 “Drug: L ARG” NCT00549575 ↗ |
| Known as | L-arginine hydrochloride | ClinicalTrials.gov intervention name — accepted as the source's own label NCT04839354 ↗ |
| Known as | L-arginine Veyron | “Drug: L-arginine (L-arginine Veyron)” NCT02117206 ↗ |
| Known as | R-Gene 10 | “10% Arginine Hydrochloride-R-Gene 10” NCT01710371 ↗ |
| Known as | Unifuzol | “the drug Unifuzol® (L-arginine)” NCT03861416 ↗ |
| Action | Activate | “aids in nitric oxide production” NCT00603720 ↗ |
| Modality | Small molecule | “An amino acid called L-arginine” NCT00134433 ↗ |
| Route | Oral | “arginine hydrochloride orally 3 times a day” NCT00029731 ↗ |