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Ubrogepant
Ubrelvy (ubrogepant) is a small molecule pharmaceutical. Ubrogepant was first approved as Ubrelvy on 2019-12-23. It is used to treat migraine disorders, migraine with aura, and migraine without aura in the USA.
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FDA Novel Drug Approvals 2019
Commercial
Therapeutic Areas
Therapeutic Area
MeSH
nervous system diseasesD009422
Trade Name
FDA
EMA
Ubrelvy
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Ubrogepant
Tradename
Company
Number
Date
Products
UBRELVYAbbVieN-211765 RX2019-12-23
2 products, RLD, RS
Labels
FDA
EMA
Brand Name
Status
Last Update
ubrelvyNew Drug Application2021-03-03
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
migraine disordersEFO_0003821D008881G43
migraine with auraEFO_0005295D020325G43.1
migraine without auraEFO_0005296D020326G43.0
Agency Specific
FDA
EMA
Expiration
Code
UBROGEPANT, UBRELVY, ABBVIE
2024-12-23NCE
Patent Expiration
Patent
Expires
Flag
FDA Information
Ubrogepant, Ubrelvy, Abbvie
101178362035-01-30DP
87540962032-07-19DS, DPU-2717
89122102031-11-10DS, DP
94995452031-11-10DS, DPU-2718
98334482031-11-10U-2718
ATC Codes
N: Nervous system drugs
— N02: Analgesics
— N02C: Antimigraine preparations
— N02CD: Calcitonin gene-related peptide (cgrp) antagonists
— N02CD04: Ubrogepant
HCPCS
No data
Clinical
Clinical Trials
15 clinical trials
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Indications Phases 4
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Migraine disordersD008881EFO_0003821G432262113
Migraine without auraD020326EFO_0005296G43.0———1—1
Migraine with auraD020325EFO_0005295G43.1———1—1
Indications Phases 3
No data
Indications Phases 2
No data
Indications Phases 1
No data
Indications Without Phase
No data
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameUBROGEPANT
INNubrogepant
Description
Ubrogepant, sold under the brand name Ubrelvy, is a medication used for the acute (immediate) treatment of migraine with or without aura (a sensory phenomenon or visual disturbance) in adults. It is not indicated for the preventive treatment of migraine. Ubrogepant is a small-molecule calcitonin gene-related peptide receptor antagonist. It is the first drug in this class approved for the acute treatment of migraine.
Classification
Small molecule
Drug classcalcitonin gene-related peptide receptor antagonists
Image (chem structure or protein)
Structure (InChI/SMILES or Protein Sequence)
C[C@@H]1[C@H](c2ccccc2)C[C@H](NC(=O)c2cnc3c(c2)C[C@@]2(C3)C(=O)Nc3ncccc32)C(=O)N1CC(F)(F)F
Identifiers
PDB—
CAS-ID1374248-77-7
RxCUI—
ChEMBL IDCHEMBL2364638
ChEBI ID—
PubChem CID68748835
DrugBankDB15328
UNII IDAD0O8X2QJR (ChemIDplus, GSRS)
Target
Agency Approved
No data
Alternate
No data
Variants
Clinical Variant
No data
Financial
Ubrelvy - Allergan
$
€
£
₣
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Ubrelvy - Warner Chilcott
$
€
£
₣
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Ubrelvy - AbbVie
$
€
£
₣
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Tabular view
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 307 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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51 adverse events reported
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