Liraglutide: dosing, evidence and sources

Regulatory status

Approved by the FDA. Marketed as VICTOZA, LIRAGLUTIDE, XULTOPHY 100/3.6. Earliest approval 2010-01-25. Application NDA022341, BLA208583, ANDA214568, ANDA215245, ANDA215421, ANDA215503, ANDA217063, ANDA217234, ANDA217590, ANDA218115.

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

Start: 0.6 mg/day, titrate to 3.0 mg/day

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 5

human RCT
NCT01179048: A Long-term, Multi-centre, International, Randomised Double-blind, Placebo-controlled Trial to Determine Liraglutide Effects on Cardiovascular Events graded on: a randomised trial — “Randomised Double-blind, Placebo-controlled Trial”
human RCT
A Randomized, Controlled Trial of 3.0 mg of Liraglutide in Weight Management (New England Journal of Medicine 2015, cited 2393x) graded on: a randomised trial — “Randomized, Controlled Trial”
human RCT
FDA approval NDA022341, BLA208583, ANDA214568, ANDA215245, ANDA215421, ANDA215503, ANDA217063, ANDA217234, ANDA217590, ANDA218115 graded on: an FDA approval (NDA022341, BLA208583, ANDA214568, ANDA215245, ANDA215421, ANDA215503, ANDA217063, ANDA217234, ANDA217590, ANDA218115), which requires adequate and well-controlled human investigations — “NDA022341, BLA208583, ANDA214568, ANDA215245, ANDA215421, ANDA215503, ANDA217063, ANDA217234, ANDA217590, ANDA218115”

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 Liraglutide, 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 Liraglutide — 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: 3751
Molecular formula: C172H265N43O51
CAS number: 204656-20-2
PubChem CID: 16134956
UniProt: P43220 (Target)
InChI key: YSDQQAXHVYUZIW-QCIJIYAXSA-N
Sequence: HAEGTFTSDVSSYLEGQAAKEFIAWLVRGRG
SMILES: CCCCCCCCCCCCCCCC(=O)N[C@@H](CCC(=O)NCCCC[C@@H](C(=O)N[C@@H](CCC(=O)O)C(=O)N[C@@H](CC1=CC=CC=C1)C(=O)N[C@@H]([C@@H](C)CC)C(=O)N[C@@H](C)C(=O)N[C@@H](CC2=CNC3=CC=CC=C32)C(=O)N[C@@H](CC(C)C)C(=O)N[C@@H](C(C)C)C(=O)N[C@@H](CCCNC(=N)N)C(=O)NCC(=O)N[C@@H](CCCNC(=N)N)C(=O)NCC(=O)O)NC(=O)[C@H](C)NC(=O)[C@H](C)NC(=O)[C@H](CCC(=O)N)NC(=O)CNC(=O)[C@H](CCC(=O)O)NC(=O)[C@H](CC(C)C)NC(=O)[C@H](CC4=CC=C(C=C4)O)NC(=O)[C@H](CO)NC(=O)[C@H](CO)NC(=O)[C@H](C(C)C)NC(=O)[C@H](CC(=O)O)NC(=O)[C@H](CO)NC(=O)[C@H]([C@@H](C)O)NC(=O)[C@H](CC5=CC=CC=C5)NC(=O)[C@H]([C@@H](C)O)NC(=O)CNC(=O)[C@H](CCC(=O)O)NC(=O)[C@H](C)NC(=O)[C@H](CC6=CN=CN6)N)C(=O)O
InChI: InChI=1S/C172H265N43O51/c1-18-20-21-22-23-24-25-26-27-28-29-30-37-53-129(224)195-116(170(265)266)59-64-128(223)180-68-41-40-50-111(153(248)199-115(62-67-135(232)233)154(249)204-120(73-100-44-33-31-34-45-100)159(254)214-140(93(11)19-2)167(262)192-97(15)146(241)201-122(76-103-79-183-108-49-39-38-48-106(103)108)157(252)203-118(72-90(5)6)158(253)212-138(91(7)8)165(260)200-110(52-43-70-182-172(177)178)149(244)184-81-130(225)193-109(51-42-69-181-171(175)176)148(243)187-84-137(236)237)196-144(239)95(13)189-143(238)94(12)191-152(247)114(58-63-127(174)222)194-131(226)82-185-151(246)113(61-66-134(230)231)198-155(250)117(71-89(3)4)202-156(251)119(75-102-54-56-105(221)57-55-102)205-162(257)124(85-216)208-164(259)126(87-218)209-166(261)139(92(9)10)213-161(256)123(78-136(234)235)206-163(258)125(86-217)210-169(264)142(99(17)220)215-160(255)121(74-101-46-35-32-36-47-101)207-168(263)141(98(16)219)211-132(227)83-186-150(245)112(60-65-133(228)229)197-145(240)96(14)190-147(242)107(173)77-104-80-179-88-188-104/h31-36,38-39,44-49,54-57,79-80,88-99,107,109-126,138-142,183,216-221H,18-30,37,40-43,50-53,58-78,81-87,173H2,1-17H3,(H2,174,222)(H,179,188)(H,180,223)(H,184,244)(H,185,246)(H,186,245)(H,187,243)(H,189,238)(H,190,242)(H,191,247)(H,192,262)(H,193,225)(H,194,226)(H,195,224)(H,196,239)(H,197,240)(H,198,250)(H,199,248)(H,200,260)(H,201,241)(H,202,251)(H,203,252)(H,204,249)(H,205,257)(H,206,258)(H,207,263)(H,208,259)(H,209,261)(H,210,264)(H,211,227)(H,212,253)(H,213,256)(H,214,254)(H,215,255)(H,228,229)(H,230,231)(H,232,233)(H,234,235)(H,236,237)(H,265,266)(H4,175,176,181)(H4,177,178,182)/t93-,94-,95-,96-,97-,98+,99+,107-,109-,110-,111-,112-,113-,114-,115-,116-,117-,118-,119-,120-,121-,122-,123-,124-,125-,126-,138-,139-,140-,141-,142-/m0/s1

Caveat on these identifiers

P43220 is the GLP-1 RECEPTOR, not the drug itself.

Notes unverified prose

FDA-approved; LEADER trial; PMID: 27295427; NCT01179048

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.