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Drugs in development · updated 13 November 2026
Amino Acids: clinical trials and development status
Other names and codes: Aminosyn Ii 15% In Plastic Container
As of 13 November 2026 Amino Acids is in 3 active clinical trials (recruiting or ongoing, phases I–III) for 3 diseases. The most advanced phase is II.
Authorisation
- EU yes, since 28 Jul 2025 (EMA)
- Italy yes (EU authorisation)
- Germany yes (EU authorisation)
- US yes (FDA)
Sources: EMA, AIFA register (open data), FDA. For Germany only the EU centralised authorisation is shown: the national BfArM register is not one of our sources.
Map of sites in Europe with recruitment status, every trial and an email when something changes. Full access free until 31 March 2027, no card needed.
What it is and what it is used for
Maapliv is a medicine used to treat an acute decompensation episode (sudden worsening) of maple syrup urine disease. Maple syrup urine disease is an inherited disorder in which the body is unable to break down certain building blocks of protein known as branched-chain amino acids (BCAAs), including leucine, isoleucine and valine. As a result, these amino acids build up in the body, including in the brain, where leucine in particular can lead to brain damage. Maapliv is for use in patients who cannot receive BCAA-free amino acids by mouth or via a feeding tube. Maple syrup urine disease is rare, and Maapliv was designated an ‘orphan medicine’ (a medicine used in rare diseases) on 26 October 2018. Further information on the orphan designation can be found on the EMA website. Maapliv contains the following amino acids as active substance: L-alanine, L-arginine, L-aspartic acid, L-cysteine hydrochloride monodhydrate, L-glutamic acid, glycine, L-histidine, L-lysine monohydrate, L-methionine, L-phenylalanine, L-proline, L-serine, taurine, L-threonine, L-tryptophan, L-tyrosine.
How it works
Maapliv consists of a solution of amino acids, but with no BCAAs. When Maapliv is given to the patient, the body uses the amino acids to make proteins, together with the excess BCAAs that have built up because of the sudden disease worsening. This lowers the level of BCAAs in the body, thereby reducing their toxic effect.
Official documents
- Maapliv: summary of product characteristics and package leaflet (EMA) · EMA update of 30 September 2025
- Maapliv: package leaflet (AIFA, in Italian) · AIFA data of 13 November 2026
- Maapliv: summary of product characteristics (AIFA, in Italian) · AIFA data of 13 November 2026
Use, doses, side effects and interactions: only these official documents are authoritative.
Diseases studied
For each disease: the drug’s most advanced phase and active trials, with the reference trial on ClinicalTrials.gov.
| Disease | Most advanced phase | Active trials | Reference trial |
|---|---|---|---|
| Acute kidney injury | II | 1 | NCT07001098 |
| Hepatocellular carcinoma | II | 1 | NCT07412054 |
| Xerostomia | I–II | 1 | NCT07309588 |
Sites in Europe
1 site of the active trials in Poland.
- Poland1
Sites declared by the sponsors on ClinicalTrials.gov; region worked out by Phuturdex from the geographic point. The list of sites with city and recruitment status is in the app. See the sites →
Everything on Amino Acids
In Phuturdex you get every trial with sponsors, countries and dates, development events, FDA and EMA approvals, patents and exclusivities, orphan designations and safety alerts, with PDF and Excel export. Free until 31 March 2027.
Open in Phuturdex →Source: Phuturdex analysis of ClinicalTrials.gov (U.S. National Library of Medicine), FDA and EMA data, updated 13 November 2026. Active trials = recruiting or ongoing, phases I–III. Diseases are those named by each trial (NLM MeSH terms). The estimated launch, when shown, refers to the United States and is a Phuturdex calculation described on the Method page, not official data: the drug may already be marketed in other countries.