Nurtec odt, Vydura(rimegepant)
Nurtec, Vydura (rimegepant) is a small molecule pharmaceutical. Rimegepant was first approved as Nurtec odt on 2020-02-27. It is used to treat migraine disorders, migraine with aura, and migraine without aura in the USA. It has been approved in Europe to treat migraine disorders.
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FDA Novel Drug Approvals 2020
Commercial
Therapeutic Areas
Therapeutic Area | MeSH |
|---|---|
| nervous system diseases | D009422 |
Trade Name
FDA
EMA
Nurtec
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Rimegepant sulfate
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| NURTEC ODT | Mylan | N-212728 RX | 2020-02-27 | 1 products, RLD, RS |
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| nurtec odt | New Drug Application | 2020-02-19 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| migraine disorders | EFO_0003821 | D008881 | G43 |
| migraine with aura | EFO_0005295 | D020325 | G43.1 |
| migraine without aura | EFO_0005296 | D020326 | G43.0 |
Agency Specific
FDA
EMA
Expiration | Code | ||
|---|---|---|---|
RIMEGEPANT SULFATE, NURTEC ODT, PFIZER | |||
| 2025-02-27 | NCE | ||
| 2024-05-27 | I-865 | ||
HCPCS
No data
Clinical
Clinical Trials
33 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 disorders | D008881 | EFO_0003821 | G43 | 1 | 3 | 9 | 5 | 4 | 20 |
| Pain | D010146 | EFO_0003843 | R52 | — | — | — | 1 | — | 1 |
| Migraine without aura | D020326 | EFO_0005296 | G43.0 | — | — | — | 1 | — | 1 |
| Migraine with aura | D020325 | EFO_0005295 | G43.1 | — | — | — | 1 | — | 1 |
| Photophobia | D020795 | H53.14 | — | — | — | 1 | — | 1 | |
| Hyperacusis | D012001 | H93.23 | — | — | — | 1 | — | 1 |
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Nasal polyps | D009298 | HP_0100582 | J33 | — | — | 1 | — | — | 1 |
| Temporomandibular joint disorders | D013705 | M26.6 | — | — | 1 | — | — | 1 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Psoriasis | D011565 | EFO_0000676 | L40 | — | 1 | — | — | — | 1 |
| Trigeminal neuralgia | D014277 | EFO_1001219 | G50.0 | — | 1 | — | — | — | 1 |
| Cluster headache | D003027 | HP_0012199 | G44.00 | — | 1 | — | — | — | 1 |
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 name | RIMEGEPANT |
| INN | rimegepant |
| Description | Rimegepant, sold under the brand name Nurtec ODT among others, is a medication used for the acute treatment of migraine with or without aura in adults and the preventative treatment of episodic migraine in adults. It is taken by mouth to dissolve on or under the tongue. It works by blocking CGRP receptors.
|
| Classification | Small molecule |
| Drug class | calcitonin gene-related peptide receptor antagonists |
| Image (chem structure or protein) | |
| Structure (InChI/SMILES or Protein Sequence) | N[C@@H]1c2cccnc2[C@H](OC(=O)N2CCC(n3c(=O)[nH]c4ncccc43)CC2)CC[C@H]1c1cccc(F)c1F |
Identifiers
| PDB | — |
| CAS-ID | 1289023-67-1 |
| RxCUI | — |
| ChEMBL ID | CHEMBL2178422 |
| ChEBI ID | — |
| PubChem CID | 51049968 |
| DrugBank | DB12457 |
| UNII ID | 997WVV895X (ChemIDplus, GSRS) |
Target
Agency Approved
No data
Alternate
No data
Variants
Clinical Variant
No data
Financial
Vydura - Pfizer
$
€
£
₣
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Tabular view
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 271 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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1,226 adverse events reported
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