Sofosbuvir: dosing, evidence and sources

Regulatory status

Approved by the FDA. Marketed as SOVALDI, HARVONI, EPCLUSA, SOFOSBUVIR AND VELPATASVIR, VOSEVI, LEDIPASVIR AND SOFOSBUVIR. Earliest approval 2013-12-06. Application NDA204671, NDA205834, NDA208341, NDA209195, NDA212477, NDA212480, NDA214187.

An approval grades as rung 1 on this site, because 21 CFR 314.126 requires adequate and well-controlled human investigations and one cannot be granted without them. It covers specific indications and doses, though, and does not transfer to other uses of the same molecule.

Dosing on file unverified

400 mg once daily

Carried from a source that labels it unverified, and reproduced with that label attached. A record of what is reported, not a recommendation. No citation on this page establishes it.

Literature on file 3

human RCT
FDA approval NDA204671, NDA205834, NDA208341, NDA209195, NDA212477, NDA212480, NDA214187 graded on: an FDA approval (NDA204671, NDA205834, NDA208341, NDA209195, NDA212477, NDA212480, NDA214187), which requires adequate and well-controlled human investigations — “NDA204671, NDA205834, NDA208341, NDA209195, NDA212477, NDA212480, NDA214187”

Not graded

2 citations whose study design could not be read from the title. Left ungraded rather than guessed at.

Identity

Space-filling 3D model of Sofosbuvir, carbon grey, nitrogen blue, oxygen red — Built from the SMILES on this record — the atoms, bonds and stereochemistry are exact. The shape is **one computed low-energy pose**, not a measured structure: a flexible peptide in solution has no single conformation. The skeletal formula below claims connectivity and nothing more, which is what we actually know.

2D chemical structure of Sofosbuvir — Built from the SMILES on this record — the atoms, bonds and stereochemistry are exact. The shape is **one computed low-energy pose**, not a measured structure: a flexible peptide in solution has no single conformation. The skeletal formula below claims connectivity and nothing more, which is what we actually know.

Molecular weight: 529.5
Molecular formula: C22H29FN3O9P
CAS number: 1190307-88-0
PubChem CID: 45375808
InChI key: TTZHDVOVKQGIBA-IQWMDFIBSA-N
SMILES: C[C@@H](C(=O)OC(C)C)N[P@](=O)(OC[C@@H]1[C@H]([C@@]([C@@H](O1)N2C=CC(=O)NC2=O)(C)F)O)OC3=CC=CC=C3
InChI: InChI=1S/C22H29FN3O9P/c1-13(2)33-19(29)14(3)25-36(31,35-15-8-6-5-7-9-15)32-12-16-18(28)22(4,23)20(34-16)26-11-10-17(27)24-21(26)30/h5-11,13-14,16,18,20,28H,12H2,1-4H3,(H,25,31)(H,24,27,30)/t14-,16+,18+,20+,22+,36-/m0/s1

Notes unverified prose

FDA-approved (Sovaldi) 2013; HCV NS5B polymerase inhibitor – small molecule, included for reference; FDA-approved (Sovaldi) – small molecule

Not on file 1

1 of the 8 fields we track hold nothing on this record, and each says why. A blank field is a bug; a named absence is a finding.

amino-acid sequencenot applicable to this compound

Each field links to every other record missing the same thing. The full ledger holds 521 gaps across 136 records.