Leuprolide: dosing, evidence and sources

Regulatory status

Approved by the FDA. Marketed as LUPRON DEPOT, ELIGARD, VABRINTY, CAMCEVI, LEUPROLIDE ACETATE. Earliest approval 1990-10-22. Application NDA020011, NDA020517, NDA021343, NDA021731, NDA211488, ANDA075471, ANDA212963, ANDA215826, ANDA217437.

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

SC: 7.5 mg monthly, 22.5 mg q3mo, 30 mg q4mo, 45 mg q6mo; IM: 3.75 mg monthly, 11.25 mg q3mo; Implant: 65 mg × 12 months

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 NDA020011, NDA020517, NDA021343, NDA021731, NDA211488, ANDA075471, ANDA212963, ANDA215826, ANDA217437 graded on: an FDA approval (NDA020011, NDA020517, NDA021343, NDA021731, NDA211488, ANDA075471, ANDA212963, ANDA215826, ANDA217437), which requires adequate and well-controlled human investigations — “NDA020011, NDA020517, NDA021343, NDA021731, NDA211488, ANDA075471, ANDA212963, ANDA215826, ANDA217437”

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 Leuprolide, 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 Leuprolide — 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: 1209.4
Molecular formula: C59H84N16O12
CAS number: 53714-56-0
PubChem CID: 657181
InChI key: GFIJNRVAKGFPGQ-LIJARHBVSA-N
Sequence: XHWSYLLRP
SMILES: CCNC(=O)[C@@H]1CCCN1C(=O)[C@H](CCCN=C(N)N)NC(=O)[C@H](CC(C)C)NC(=O)[C@@H](CC(C)C)NC(=O)[C@H](CC2=CC=C(C=C2)O)NC(=O)[C@H](CO)NC(=O)[C@H](CC3=CNC4=CC=CC=C43)NC(=O)[C@H](CC5=CN=CN5)NC(=O)[C@@H]6CCC(=O)N6
InChI: InChI=1S/C59H84N16O12/c1-6-63-57(86)48-14-10-22-75(48)58(87)41(13-9-21-64-59(60)61)68-51(80)42(23-32(2)3)69-52(81)43(24-33(4)5)70-53(82)44(25-34-15-17-37(77)18-16-34)71-56(85)47(30-76)74-54(83)45(26-35-28-65-39-12-8-7-11-38(35)39)72-55(84)46(27-36-29-62-31-66-36)73-50(79)40-19-20-49(78)67-40/h7-8,11-12,15-18,28-29,31-33,40-48,65,76-77H,6,9-10,13-14,19-27,30H2,1-5H3,(H,62,66)(H,63,86)(H,67,78)(H,68,80)(H,69,81)(H,70,82)(H,71,85)(H,72,84)(H,73,79)(H,74,83)(H4,60,61,64)/t40-,41-,42-,43+,44-,45-,46-,47-,48-/m0/s1

Notes unverified prose

FDA-approved (Lupron, Eligard, Camcevi, Viadur); Drugs.com; FDA-approved (Lupron, Eligard)

Not on file 0

All 8 tracked fields hold a value on this record: molecular weight and formula, CAS number, PubChem CID, amino-acid sequence, SMILES, InChI and InChI key.

Counted from the record itself, not from what a source said it was missing. 136 of 185 records still have at least one empty.