In short
Biotin sodium is a form of the B vitamin biotin, authorised as a medicine in Spain and studied in a Phase 3 trial for children with rare inherited metabolic conditions. The trial compares a chewable pharmacy-made formulation against the commercial product in 14 paediatric patients with biotinidase deficiency and methylcrotonylglycinuria.
Key points
- Biotin sodium is a water-soluble B vitamin used to treat rare metabolic diseases.
- One Phase 3 trial is authorised in Spain, enrolling 14 children.
- The trial studies biotinidase deficiency and methylcrotonylglycinuria.
- It compares a chewable pharmacy-made biotin with the commercial product.
- The main measure is tolerability and patient-reported symptoms.
- Biotin is already authorised as a medicine in Spain.
What is biotin sodium?
Biotin sodium, also known as D-biotin or simply biotin, is a water-soluble vitamin belonging to the B-complex group. It is a chemically synthesised substance that is already authorised as a medicine in Spain, where it is marketed under the names Medebiotin Fuerte solución inyectable and Medebiotín Fuerte Comprimidos by Laboratorio Reig Jofre, S.A. The substance is classified under the Anatomical Therapeutic Chemical code A11HA05, which places it among other plain vitamin preparations.
How does biotin sodium work?
Biotin acts as a cofactor for several enzymes involved in the breakdown of certain amino acids and fatty acids. In conditions such as biotinidase deficiency, the body cannot recycle biotin properly, leading to a functional biotin shortage. Providing biotin as a medicine helps restore the activity of these enzymes and supports normal metabolism.
Which conditions is it used or studied for?
- Biotinidase deficiency — a rare inherited condition in which the body cannot reuse biotin, leading to neurological and skin problems if untreated.
- Methylcrotonylglycinuria — a rare metabolic disorder affecting the breakdown of the amino acid leucine, which can cause developmental and metabolic issues.
How is biotin sodium given?
Biotin is available as a tablet and as a solution for injection that is taken by mouth (oral use). The trial also uses a chewable master formula prepared in a hospital pharmacy.
What do the clinical trials show?
One Phase 3 trial is authorised in Spain, enrolling 14 children with biotinidase deficiency or methylcrotonylglycinuria. The study compares the tolerability of the commercial biotin product with a chewable pharmacy-made formulation, aiming to improve treatment adherence in children with these rare diseases. The primary outcome is a visual scale together with the collection of subjective symptoms reported by the patient.
What side effects are known?
The sources provided do not include a list of side effects for biotin sodium.