Source: FDA, National Drug Code (US) Revision Year: 2025
Vepdegestrant is a heterobifunctional protein degrader. It is a small molecule comprised of an estrogen receptor binding domain joined by a linker to an E3 ligase binding domain. The chemical name of vepdegestrant is 2,6-piperidinedione, 3-[1,3-dihydro-1-oxo-5-[4-[[1-[4-[(1 R,2 S)-1,2,3,4-tetrahydro-6-hydroxy-2-phenyl-1-naphthalenyl]phenyl]-4-piperidinyl]methyl]-1-piperazinyl]-2 Hisoindol-2-yl], (3 S)-.
The chemical structure of vepdegestrant is:
Vepdegestrant is white to off-white to pale yellow solid with the molecular formula of C45H49N5O4 and a molecular weight of 723.90 Daltons. Vepdegestrant solubility is pH dependent. The solubility ranges from freely soluble under gastric pH conditions to slightly soluble under intestinal pH conditions.
VEPPANU is supplied as blue film-coated, immediate release tablets containing either 100 mg or 200 mg vepdegestrant together with: colloidal silicon dioxide, croscarmellose sodium, hypromellose, lactose monohydrate, microcrystalline cellulose, sodium stearyl fumarate, vitamin E-polyethylene glycol succinate, and Opadry QX Blue as inactive ingredients. Opadry QX Blue film-coating contains: FD&C Blue No. 2 (indigo carmine) aluminum lake, ferric oxide yellow (yellow iron oxide), ferrosoferric oxide (black iron oxide), glyceryl mono and dicaprylocaprate (glycerol monocaprylocaprate), polyvinyl alcohol, polyvinyl alcohol polyethylene glycol graft copolymer [macrogol poly (vinyl alcohol) grafted copolymer], talc, and titanium dioxide.
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Tablets:
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VEPPANU (vepdegestrant) film-coated tablets for oral use are supplied in bottles of 30 tablets with child‑resistant closures as follows:
Manufactured by: Pfizer Inc., New York, NY 10001 Distributed by: Arvinas Operations, Inc., New Haven, CT 06511 |
| Drug | Countries | |
|---|---|---|
| VEPPANU | United States |
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