Telaprevir: dosing, evidence and sources

Regulatory status

Approved by the FDA. Marketed as INCIVEK. Earliest approval 2011-05-23. Application NDA201917.

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

750 mg (two 375 mg tablets) orally 3x/day (every 7-9h) with food

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 NDA201917 graded on: an FDA approval (NDA201917), which requires adequate and well-controlled human investigations — “NDA201917”

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 Telaprevir, 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 Telaprevir — 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: 679.8
Molecular formula: C36H53N7O6
CAS number: 402957-28-2
PubChem CID: 3010818
InChI key: BBAWEDCPNXPBQM-GDEBMMAJSA-N
SMILES: CCC[C@@H](C(=O)C(=O)NC1CC1)NC(=O)[C@@H]2[C@H]3CCC[C@H]3CN2C(=O)[C@H](C(C)(C)C)NC(=O)[C@H](C4CCCCC4)NC(=O)C5=NC=CN=C5
InChI: InChI=1S/C36H53N7O6/c1-5-10-25(29(44)34(48)39-23-15-16-23)40-33(47)28-24-14-9-13-22(24)20-43(28)35(49)30(36(2,3)4)42-32(46)27(21-11-7-6-8-12-21)41-31(45)26-19-37-17-18-38-26/h17-19,21-25,27-28,30H,5-16,20H2,1-4H3,(H,39,48)(H,40,47)(H,41,45)(H,42,46)/t22-,24-,25-,27-,28-,30+/m0/s1

Notes unverified prose

FDA-approved (Incivek) 2011; HCV protease inhibitor – peptide-based, included for reference; FDA-approved (Incivek) – peptide-based

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.