Molecule
Risdiplam is a survival of motor neuron 2 splicing modifier indicated for the treatment of spinal muscular atrophy (SMA) in pediatric and adult patients. It is available as powder for oral solution and tablets. MedsAcross supplies Risdiplam for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.
Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review
From the regulator-approved product information. Each section names its source.
EVRYSDI is indicated for the treatment of spinal muscular atrophy (SMA) in pediatric and adult patients. EVRYSDI is a survival of motor neuron 2 (SMN2) splicing modifier indicated for the treatment of spinal muscular atrophy (SMA) in pediatric and adult patients.
Source: US FDA prescribing information
Risdiplam is a survival of motor neuron 2 (SMN2) splicing modifier designed to treat patients with spinal muscular atrophy (SMA) caused by mutations in chromosome 5q that lead to SMN protein deficiency. Using in vitro assays and studies in transgenic animal models of SMA, risdiplam was shown to increase exon 7 inclusion in SMN2 messenger ribonucleic acid (mRNA) transcripts and production of full-length SMN protein in the brain. In vitro and in vivo data indicate that risdiplam may cause alternative splicing of additional genes, including FOXM1 and MADD. FOXM1 and MADD are thought to be involved in cell cycle regulation and apoptosis, respectively, and have been identified as possible contributors to adverse effects seen in animals.
Source: US FDA prescribing information
Administer once daily with or without food per the table below: Age and Body Weight Recommended Daily Dosage Dosage Form Less than 2 months of age 0.15 mg/kg EVRYSDI for Oral Solution 2 months to less than 2 years of age 0.2 mg/kg 2 years of age and older weighing less than 20 kg 0.25 mg/kg 2 years of age and older weighing 20 kg or more 5 mg EVRYSDI for Oral Solution or EVRYSDI Tablet Swallow EVRYSDI tablet whole with water or dispersed in non-chlorinated drinking water (e.g., filtered water). Administer EVRYSDI for oral solution with the provided oral syringe. EVRYSDI for oral solution must be constituted by a healthcare provider prior to dispensing. See Full Prescribing Information for important preparation and administration instructions.
Source: US FDA prescribing information
None. None.
Source: US FDA prescribing information
The most common adverse reactions in later-onset SMA (incidence at least 10% of patients treated with EVRYSDI and more frequent than control) were fever, diarrhea, and rash. The most common adverse reactions in infantile-onset SMA were similar to those observed in later-onset SMA patients. Additionally, adverse reactions with an incidence of at least 10% were upper respiratory tract infection, lower respiratory tract infection, constipation, vomiting, and cough.
Source: US FDA prescribing information
Avoid coadministration with drugs that are substrates of multidrug and toxin extrusion (MATE) transporters. Effect of EVRYSDI on Substrates of Multidrug and Toxin Extrusion (MATE) Protein Transporters Based on in vitro data, EVRYSDI may increase plasma concentrations of drugs eliminated via MATE1 or MATE2-K, such as metformin. Avoid coadministration of EVRYSDI with MATE substrates. If coadministration cannot be avoided, monitor for drug-related toxicities and consider dosage reduction of the coadministered drug (based on the labeling of that drug) if needed.
Source: US FDA prescribing information
Store at 20°C to 25°C (68°F to 77°F), excursions permitted between 15°C to 30°C (59°F to 86°F). Keep the bottle tightly closed in order to protect from moisture.
Source: US FDA prescribing information
For healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
2 presentations of Risdiplam, sorted by availability.
| Medicine | Manufacturer | Register | Availability |
|---|---|---|---|
| Evrysdi 0.75 mg/mL powder for oral solutionOral | Genentech | US FDA | Available on request |
| Evrysdi 5 mg tabletOral | Genentech | US FDA | Available on request |
1 brand names across 1 markets.
United States
Approval facts from US FDA, EMA and CDSCO data, and registration status by country where we hold register data.
Yes, on request. MedsAcross lists 2 presentations of Risdiplam and sources them for licensed hospitals, importers and physicians against valid import documents.
The catalogue lists 1 brand names for Risdiplam, including Evrysdi.
Yes. The US FDA first approved Risdiplam on 7 August 2020, according to Drugs@FDA.
Yes. Risdiplam has a central EU marketing authorisation (status: authorised), according to European Medicines Agency data.
No listed presentation of Risdiplam is recorded as needing a cold chain. Storage conditions are shown on each presentation page.
Risdiplam is classified under ATC code M09AX10 (Risdiplam).
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