All FDA-approved EMA-approved PMDA-approved
Target Card Uniprot Example: P23975

taurursodiol 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |

Stem definition	Drug id	CAS RN
	5679	14605-22-2

Description:

Molecule

Description

Molfile Inchi Smiles Synonyms: taurursodiol taurursodiol sodium tauroursdeoxycholic acid ursodoxicoltaurine

Relyvrio contains two active ingredients: sodium phenylbutyrate and taurursodiol, being indicated for the treatment of amyotrophic lateral sclerosis (ALS) in adults.The mechanism by which relyvrio exerts its therapeutic effects in patients with ALS is unknown. Molecular weight: 499.71 Formula: C26H45NO6S CLOGP: 2.07 LIPINSKI: 0 HAC: 7 HDO: 4 TPSA: 123.93 ALOGS: -4.82 ROTB: 7 Status: ONP Legend: OFP - off patent OFM - off market ONP - on patent

Drug dosage:

None

ADMET properties:

None

Approvals:

Date	Agency	Company	Orphan
Sept. 29, 2022	FDA	AMYLYX

FDA Adverse Event Reporting System (Female)

None

FDA Adverse Event Reporting System (Male)

None

FDA Adverse Event Reporting System (Geriatric)

None

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

Source	Code	Description
MeSH PA	D000890	Anti-Infective Agents
MeSH PA	D000998	Antiviral Agents
MeSH PA	D002756	Cholagogues and Choleretics
MeSH PA	D005765	Gastrointestinal Agents

Drug Use | Suggest Off label Use Form| |View source of the data|

Disease	Relation	SNOMED_ID	DOID
Amyotrophic lateral sclerosis	indication	86044005	DOID:332

🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

None

Orange Book patent data (new drug applications)

Formulation strength	Trade name	Applicant	Application number	Approval date	Type	Dose form	Route	Patent number	Patent expiration date	Patent use
3GM/PACKET; 1GM/PACKET	RELYVRIO	AMYLYX	N216660	Sept. 29, 2022	RX	FOR SUSPENSION	ORAL	10251896	Dec. 24, 2033	TREATMENT OF AMYOTROPHIC LATERAL SCLEROSIS (ALS) IN ADULTS
3GM/PACKET; 1GM/PACKET	RELYVRIO	AMYLYX	N216660	Sept. 29, 2022	RX	FOR SUSPENSION	ORAL	10857162	Dec. 24, 2033	TREATMENT OF AMYOTROPHIC LATERAL SCLEROSIS (ALS) IN ADULTS
3GM/PACKET; 1GM/PACKET	RELYVRIO	AMYLYX	N216660	Sept. 29, 2022	RX	FOR SUSPENSION	ORAL	9872865	Dec. 24, 2033	TREATMENT OF AMYOTROPHIC LATERAL SCLEROSIS (ALS) IN ADULTS

Orange Book exclusivity data (new drug applications)

Formulation strength	Trade name	Applicant	Application number	Approval date	Type	Dose form	Route	Exclusivity date	Description
3GM/PACKET; 1GM/PACKET	RELYVRIO	AMYLYX	N216660	Sept. 29, 2022	RX	FOR SUSPENSION	ORAL	Sept. 29, 2027	NEW CHEMICAL ENTITY
3GM/PACKET; 1GM/PACKET	RELYVRIO	AMYLYX	N216660	Sept. 29, 2022	RX	FOR SUSPENSION	ORAL	Sept. 29, 2029	TREATMENT OF AMYOTROPHIC LATERAL SCLEROSIS (ALS) IN ADULTS

Bioactivity Summary:

Target	Class	Pharos	UniProt	Action	Type	Activity value (-log[M])	Mechanism action	Bioact source	MoA source
Phospholipase A2	Enzyme	P04054	PA21B_HUMAN		Kd	5		CHEMBL
Ectonucleotide pyrophosphatase/phosphodiesterase family member 2	Enzyme	Q13822	ENPP2_HUMAN		IC50	4.99		CHEMBL

External reference:

ID	Source
5D5	PDB_CHEM_ID
CHEMBL272427	ChEMBL_ID
C031655	MESH_SUPPLEMENTAL_RECORD_UI
DB08834	DRUGBANK_ID
019092	NDDF
4041745	VANDF
C0075857	UMLSCUI
11388	INN_ID
35807-85-3	SECONDARY_CAS_RN
D11836	KEGG_DRUG
9848818	PUBCHEM_CID
2613950	RXNORM
40914	MMSL
40943	MMSL
d09918	MMSL
60EUX8MN5X	UNII

Pharmaceutical products:

Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
RELYVRIO	HUMAN PRESCRIPTION DRUG LABEL	2	73063-035	POWDER, FOR SUSPENSION	1 g	ORAL	NDA	27 sections
RELYVRIO	HUMAN PRESCRIPTION DRUG LABEL	2	73063-035	POWDER, FOR SUSPENSION	1 g	ORAL	NDA	27 sections