Drugs / amino acids
amino acids
also known as
leucine · L-leucine · L-methionine · L-Phenylalanine · L-Tryptophan · deuterated leucine · L-Isoleucine · L-Threonine · +2 more
Regulatory milestones approvals, filings & regulatory actions · 2 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Approved | EU (EMA) | Maapliv | — | 2025-07-28 | europa.eu ↗ |
| Approved | US (FDA) | FREAMINE HBC 6.9% | — | 1971-09-24 | fda.gov ↗ |
Trials 24 · a red edge is where a trial was stopped
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 01 trial | ||||||
| Phase 0 | NCT02837861 | Mar 2017 → Oct 2019 | — | Boston Medical Center | Completed | No outcome recorded |
| Phase 11 trial | ||||||
| Phase 1 | NCT04238416 | Nov 2019 → Dec 2021 | hepatic encephalopathy, liver disorder | Post Graduate Institute of Medical Education and Research, Chandigarh | Completed | No outcome recorded |
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT01362595 | Jun 2013 → Jun 2018 | Diamond-Blackfan anemia, congenital anemia | Northwell Health | Completed | No outcome recorded |
| Phase 212 trials | ||||||
| Phase 2 | NCT07647003 | Oct 2026 → May 2027 expected | hypertensive disorder | NuSirt Biopharma | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07670195 | Jul 2026 → Jun 2027 expected | traumatic brain injury, traumatic encephalopathy | Akiva Cohen | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07001098 | Sep 2025 → Nov 2026 expected | acute kidney injury | Stanford University | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT06829498 | Apr 2025 → Aug 2026 overdue | brain injury, traumatic encephalopathy | Akiva Cohen | Active not recruiting | No outcome recorded |
| Phase 2 | NCT06580145 | Feb 2025 → Jun 2028 expected | major depressive disorder | Emory University | Recruiting | No outcome recorded |
| Phase 2 | NCT03364335 | Jan → Aug 2018 | obesity disorder | NuSirt Biopharma | Completed | No outcome recorded |
| Phase 2 | NCT03021902 | Sep 2017 → Jan 2025 | acute respiratory failure | Clinical Evaluation Research Unit at Kingston General Hospital | Completed | No outcome recorded |
| Phase 2 | NCT03079297 | Mar 2017 → Oct 2021 | major depressive disorder | University of Texas Southwestern Medical Center | Terminated | No outcome recorded |
| Phase 2 | NCT02546609 | Nov 2015 → Nov 2016 | NAFLD1 | NuSirt Biopharma | Completed | No outcome recorded |
| Phase 2 | NCT02435277 | Oct 2014 → Sep 2015 | type 2 diabetes mellitus | NuSirt Biopharma | Completed | No outcome recorded |
| Phase 2 | NCT02386267 | Sep 2014 → Mar 2015 | Diamond-Blackfan anemia | Federal Scientific Clinical Centre of Pediatric Hematology, Oncology and Immunology named after Dmitry Rogache | Unknown | No outcome recorded |
| Phase 2 | NCT02151461 | Jul 2014 → Aug 2015 | type 2 diabetes mellitus | NuSirt Biopharma | Completed | No outcome recorded |
| Phase 33 trials | ||||||
| Phase 3 | NCT06121479 | Nov 2023 → Sep 2025 overdue | — | Mahidol University | Enrolling by invitation | No outcome recorded |
| Phase 3 | NCT03709264 | Oct 2019 → Jan 2024 | — | Vita-Salute San Raffaele University | Completed | No outcome recorded |
| Phase 3 | NCT00865202 | Dec 2008 → Dec 2012 | delirium | University of Colorado, Denver | Completed | No outcome recorded |
| Phase 42 trials | ||||||
| Phase 4 | NCT06433310 | Oct 2024 → Dec 2027 expected | — | Weill Medical College of Cornell University | Recruiting | No outcome recorded |
| Phase 4 | NCT00226356 | Dec 2004 → Jun 2007 | major depressive disorder | Cambridge Health Alliance | Completed | No outcome recorded |
| Phase not applicable4 trials | ||||||
| — | NCT06929637 | Sep 2025 → Sep 2028 expected | nutritional disorder | University Hospital, Martin | Not yet recruiting | No outcome recorded |
| — | NCT03644836 | Jan 2015 → Jan 2018 | chronic obstructive pulmonary disease | Poitiers University Hospital | Completed | No outcome recorded |
| — | NCT01860573 | Nov 2008 → Mar 2013 | — | Women and Infants Hospital of Rhode Island | Completed | No outcome recorded |
| — | NCT00005889 | Oct 1999 → ? | hyperglycemia | National Center for Research Resources (NCRR) | Unknown | No outcome recorded |
Also used as a comparator or background therapy in 6 trials
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase not applicable6 trials | ||||||
| — | NCT05197231 Background | Dec 2022 → Dec 2027 | critical illness polyneuropathy, muscular atrophy | Karolinska University Hospital | Suspended | No outcome recorded |
| — | NCT05576038 Comparator | Dec 2022 → Apr 2025 overdue | celiac disease, inborn disorder of tryptophan metabolism | McMaster University | Recruiting | No outcome recorded |
| — | NCT03259594 Background | Mar 2018 → Dec 2020 | non-congenital cyst of kidney | ou tongwen | Unknown | No outcome recorded |
| — | NCT02216253 Comparator | Oct 2014 → Aug 2015 | pelvic organ prolapse, urinary tract infection | IRCCS San Raffaele | Completed | No outcome recorded |
| — | NCT01208324 Comparator | Mar 2010 → Nov 2018 | premature menopause | University of Colorado, Denver | Completed | No outcome recorded |
| — | NCT00152945 Background | Apr 2005 → Jul 2008 | — | University Health Network, Toronto | Completed | No outcome recorded |
Press releases naming this drug 1 release
| Date | Issuer | Release |
|---|---|---|
| 2013-02-20 | Otsuka Pharmaceutical Development & Commercialization, Inc. | Otsuka Pharmaceutical Contributes to the Success and Development of the Tokyo Marathon as a Total Health Care Company Supporting Safe Running and Encouraging Runners to Complete the Full Distance with Amino Acids, Fluids and Electrolytes otsuka.co.jp ↗ |
Evidence & citations 14 cited values
Every value below carries the sentence it was read from. 30 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | amino acids | “Infusion of amino acids once daily - dose 1g/kg, maximum 100 g daily for 3 consecutive days starting D1 after kidney transplantation procedure” NCT06929637 ↗ |
| Known as | deuterated leucine | “The form of leucine that will be administered is deuterated leucine” NCT00152945 ↗ |
| Known as | L-Isoleucine | “L-Isoleucine (4.2 g)” NCT01208324 ↗ |
| Known as | L-leucine | “Two tablets 550 mg L-leucine + 250 mg metformin and one tablet 1.0 mg sildenafil per dose; 3 tablets/dose orally BID” NCT07647003 ↗5“3 capsules BID with each capsule containing 366.7 mg L-Leucine and 41.7 mg of metformin” NCT02435277 ↗ “L-Leucine (6.6 g)” NCT01208324 ↗ |
| Known as | L-methionine | “L-Methionine (1.5 g)” NCT01208324 ↗ |
| Known as | L-Phenylalanine | “L-Phenylalanine (6.6 g)” NCT01208324 ↗ |
| Known as | L-Threonine | “L-Threonine (3.0 g)” NCT01208324 ↗ |
| Known as | L-Tryptophan | ClinicalTrials.gov intervention name — accepted as the source's own label NCT05576038 ↗ |
| Known as | L-Valine | “L-Valine (4.8 g)” NCT01208324 ↗ |
| Known as | leucine | “In preclinical, analysis of ipsilateral hippocampi isolated from mice after traumatic brain injury (TBI) demonstrated that only the concentrations of the three branched chain...” NCT07670195 ↗10“In preclinical, analysis of ipsilateral hippocampi isolated from mice after traumatic brain injury (TBI) demonstrated that only the concentrations of the three branched chain...” NCT06829498 ↗ “The use of branched-chain amino acids (AARs) such as valine, leucine, isoleucine in this indication can be fully justified because they stimulate protein synthesis and promote...” NCT03644836 ↗ “Each sachet contains 6.84 grams of BCAA (valine 1.82 grams, leucine 3.29 grams, isoleucine 1.72 grams), total protein 17.08 grams, carbohydrates 25.48 grams, fat 5.66 grams,...” NCT06121479 ↗ “The objective of this study was to evaluate the effects of a triple combination of leucine, metformin, and sildenafil (NS-0200) on body weight and obesity comorbidities in a...” PMID 30569637 ↗ Jan 2019 “two fixed-dose combinations of leucine and sildenafil or two fixed-dose combinations of leucine, sildenafil and metformin” NCT03364335 ↗ “Branched-Chain Amino Acids (BCAA; Isoleucine, leucine and valine) have attracted particular interest” PMID 30568347 ↗ Jun 2018 “1100 mg L Leucine in combination with 125 mg of Metformin BID” NCT02151461 ↗ |
| Known as | Tryptan | “L-tryptophan* supplements (Tryptan, Valeant Canada LP): each treatment capsule contains 500 mg of L-Tryptophan” NCT05576038 ↗ |
| Action | Activate | “responsible for activating the aryl hydrocarbon receptor (AhR)” NCT05576038 ↗ |
| Modality | Small molecule | “Leucine, an amino acid and glycerol, an intermediary metabolite” NCT00152945 ↗ |
| Route | Intravenous | “[1-C]leucine IV over 10 hours” NCT00005889 ↗ |