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ponesimod 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | PK/Tox | Related Drugs | BioActivity |
| Stem definition | Drug id | CAS RN |
|---|---|---|
| immunomodulators, both stimulant/suppressive and stimulant | 5446 | 854107-55-4 |
Description:
| Molecule | Description |
|---|---|
|
Synonyms:
|
Ponesimod is a sphingosine 1-phosphate (S1P) receptor 1 modulator that binds with high affinity to S1P receptor 1. Ponesimod blocks the capacity of lymphocytes to egress from lymph nodes, reducing the number of lymphocytes in peripheral blood. The mechanism by which ponesimod exerts therapeutic effects in multiple sclerosis is unknown, but may involve reduction of lymphocyte migration into the central nervous system
Legend: OFP - off patent OFM - off market ONP - on patent |
Drug dosage:
| Dose | Unit | Route |
|---|---|---|
| 20 | mg | O |
ADMET properties:
| Property | Value | Reference |
|---|---|---|
| BA (Bioavailability) | 83.80 % |
Predicted pharmacokinetic/toxicological properties (PK-AZ):
| Property | Description | Value | Unit | Confidence | Similarity |
|---|---|---|---|---|---|
| azlogd74 | LogD at pH 7.4 | 4.226 | High | 1 | |
| caco2-efflux | Caco-2 efflux ratio (BA/AB) | 1.714 | High | 1 | |
| caco2-intrinsic-papp | Caco-2 intrinsic apparent permeability | 32.659 | 10^-6 cm/s | High | 1 |
| dh-clint | Dog hepatocyte intrinsic clearance | 38.194 | uL/min/10^6 cells | High | 1 |
| dppb | Dog plasma protein binding (% unbound) | 0.590 | % | High | 1 |
| fcs-ppb | Fetal calf serum protein binding (% unbound) | 1.080 | % | High | 1 |
| herg | hERG pIC50 | 5.231 | pIC50 | High | 1 |
| hh-clint | Human hepatocyte intrinsic clearance | 33.729 | uL/min/10^6 cells | High | 1 |
| hlm-clint | Human liver microsomal intrinsic clearance | 42.267 | uL/min/mg protein | High | 1 |
| hppb | Human plasma protein binding (% unbound) | 0.410 | % | High | 1 |
| mdck-mdr1-efflux | MDCK-MDR1 efflux ratio | 1.667 | High | 1 | |
| mh-clint | Mouse hepatocyte intrinsic clearance | 64.121 | High | 1 | |
| mppb | Mouse plasma protein binding (% unbound) | 0.610 | High | 1 | |
| nih-mdck-mdr1-efflux | NIH MDCK-MDR1 efflux ratio | 5.929 | High | 1 | |
| pfas-class | PFAS structural alert (1 = True, 0 = False) | 0 | |||
| pppb | Pig plasma protein binding (% unbound) | 1.280 | % | High | 1 |
| rh-clint | Rat hepatocyte intrinsic clearance | 84.918 | uL/min/10^6 cells | High | 1 |
| rh-fuinc | Rat hepatocyte fraction unbound in incubation | 5.280 | % | High | 1 |
| rppb | Rat plasma protein binding (% unbound) | 0.490 | % | High | 1 |
| solubility-dd | Solubility at pH 7.4 in DMSO | 2.265 | uM | High | 1 |
Approvals:
| Date | Agency | Company | Orphan |
|---|---|---|---|
| March 18, 2021 | FDA | JANSSEN PHARMACEUTICALS Inc | |
| May 19, 2021 | EMA | Janssen-Cilag International N.V. |
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 |
|---|---|---|
| ATC | L04AE04 | ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS IMMUNOSUPPRESSANTS IMMUNOSUPPRESSANTS Sphingosine-1-phosphate (S1P) receptor modulators |
| MeSH PA | D000081243 | Sphingosine 1 Phosphate Receptor Modulators |
| MeSH PA | D007155 | Immunologic Factors |
| MeSH PA | D007166 | Immunosuppressive Agents |
| FDA MoA | N0000181815 | Sphingosine 1-Phosphate Receptor Modulators |
| FDA EPC | N0000181816 | Sphingosine 1-phosphate Receptor Modulator |
| CHEBI has role | CHEBI:35705 | immunosuppressive agent |
| CHEBI has role | CHEBI:50748 | antipsoriatic |
Related Drugs by ATC class:
L04AE Sphingosine-1-phosphate (S1P) receptor modulators 4 drugs
Drug Use | Suggest Off label Use Form| |View source of the data|
| Disease | Relation | SNOMED_ID | DOID |
|---|---|---|---|
| Relapsing forms of multiple sclerosis | indication | 24700007 | DOID:2377 |
| Unstable angina | contraindication | 4557003 | |
| Myocardial infarction | contraindication | 22298006 | DOID:5844 |
| Complete atrioventricular block | contraindication | 27885002 | |
| Mobitz type II atrioventricular block | contraindication | 28189009 | DOID:11312 |
| Sick sinus syndrome | contraindication | 36083008 | DOID:13884 |
| Heart failure | contraindication | 84114007 | DOID:6000 |
| Decompensated cardiac failure | contraindication | 195111005 | |
| Cerebrovascular accident | contraindication | 230690007 | |
| Transient ischemic attack | contraindication | 266257000 | DOID:224 |
🐶 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 |
|---|---|---|---|---|---|---|---|---|---|---|
| 10MG | PONVORY | VANDA PHARMS INC | N213498 | March 18, 2021 | RX | TABLET | ORAL | 9062014 | May 6, 2032 | TREATMENT OF RELAPSING FORMS OF MULTIPLE SCLEROSIS (MS), TO INCLUDE CLINICALLY ISOLATED SYNDROME, RELAPSING-REMITTING DISEASE, AND ACTIVE SECONDARY PROGRESSIVE DISEASE, IN ADULTS |
| 20MG | PONVORY | VANDA PHARMS INC | N213498 | March 18, 2021 | RX | TABLET | ORAL | 9062014 | May 6, 2032 | TREATMENT OF RELAPSING FORMS OF MULTIPLE SCLEROSIS (MS), TO INCLUDE CLINICALLY ISOLATED SYNDROME, RELAPSING-REMITTING DISEASE, AND ACTIVE SECONDARY PROGRESSIVE DISEASE, IN ADULTS |
| 2MG | PONVORY | VANDA PHARMS INC | N213498 | March 18, 2021 | RX | TABLET | ORAL | 9062014 | May 6, 2032 | TREATMENT OF RELAPSING FORMS OF MULTIPLE SCLEROSIS (MS), TO INCLUDE CLINICALLY ISOLATED SYNDROME, RELAPSING-REMITTING DISEASE, AND ACTIVE SECONDARY PROGRESSIVE DISEASE, IN ADULTS |
| 3MG | PONVORY | VANDA PHARMS INC | N213498 | March 18, 2021 | RX | TABLET | ORAL | 9062014 | May 6, 2032 | TREATMENT OF RELAPSING FORMS OF MULTIPLE SCLEROSIS (MS), TO INCLUDE CLINICALLY ISOLATED SYNDROME, RELAPSING-REMITTING DISEASE, AND ACTIVE SECONDARY PROGRESSIVE DISEASE, IN ADULTS |
| 4MG | PONVORY | VANDA PHARMS INC | N213498 | March 18, 2021 | RX | TABLET | ORAL | 9062014 | May 6, 2032 | TREATMENT OF RELAPSING FORMS OF MULTIPLE SCLEROSIS (MS), TO INCLUDE CLINICALLY ISOLATED SYNDROME, RELAPSING-REMITTING DISEASE, AND ACTIVE SECONDARY PROGRESSIVE DISEASE, IN ADULTS |
| 5MG | PONVORY | VANDA PHARMS INC | N213498 | March 18, 2021 | RX | TABLET | ORAL | 9062014 | May 6, 2032 | TREATMENT OF RELAPSING FORMS OF MULTIPLE SCLEROSIS (MS), TO INCLUDE CLINICALLY ISOLATED SYNDROME, RELAPSING-REMITTING DISEASE, AND ACTIVE SECONDARY PROGRESSIVE DISEASE, IN ADULTS |
| 6MG | PONVORY | VANDA PHARMS INC | N213498 | March 18, 2021 | RX | TABLET | ORAL | 9062014 | May 6, 2032 | TREATMENT OF RELAPSING FORMS OF MULTIPLE SCLEROSIS (MS), TO INCLUDE CLINICALLY ISOLATED SYNDROME, RELAPSING-REMITTING DISEASE, AND ACTIVE SECONDARY PROGRESSIVE DISEASE, IN ADULTS |
| 7MG | PONVORY | VANDA PHARMS INC | N213498 | March 18, 2021 | RX | TABLET | ORAL | 9062014 | May 6, 2032 | TREATMENT OF RELAPSING FORMS OF MULTIPLE SCLEROSIS (MS), TO INCLUDE CLINICALLY ISOLATED SYNDROME, RELAPSING-REMITTING DISEASE, AND ACTIVE SECONDARY PROGRESSIVE DISEASE, IN ADULTS |
| 8MG | PONVORY | VANDA PHARMS INC | N213498 | March 18, 2021 | RX | TABLET | ORAL | 9062014 | May 6, 2032 | TREATMENT OF RELAPSING FORMS OF MULTIPLE SCLEROSIS (MS), TO INCLUDE CLINICALLY ISOLATED SYNDROME, RELAPSING-REMITTING DISEASE, AND ACTIVE SECONDARY PROGRESSIVE DISEASE, IN ADULTS |
| 9MG | PONVORY | VANDA PHARMS INC | N213498 | March 18, 2021 | RX | TABLET | ORAL | 9062014 | May 6, 2032 | TREATMENT OF RELAPSING FORMS OF MULTIPLE SCLEROSIS (MS), TO INCLUDE CLINICALLY ISOLATED SYNDROME, RELAPSING-REMITTING DISEASE, AND ACTIVE SECONDARY PROGRESSIVE DISEASE, IN ADULTS |
| 10MG | PONVORY | VANDA PHARMS INC | N213498 | March 18, 2021 | RX | TABLET | ORAL | 10220023 | Dec. 10, 2035 | TREATMENT OF RELAPSING FORMS OF MULTIPLE SCLEROSIS (MS), TO INCLUDE CLINICALLY ISOLATED SYNDROME, RELAPSING-REMITTING DISEASE, AND ACTIVE SECONDARY PROGRESSIVE DISEASE, IN ADULTS USING A DOSE TITRATION SCHEDULE FOLLOWED BY A MAINTENANCE DOSE |
| 10MG | PONVORY | VANDA PHARMS INC | N213498 | March 18, 2021 | RX | TABLET | ORAL | 12336980 | Dec. 10, 2035 | TREATMENT OF RELAPSING FORMS OF MULTIPLE SCLEROSIS (MS), TO INCLUDE CLINICALLY ISOLATED SYNDROME, RELAPSING-REMITTING DISEASE, AND ACTIVE SECONDARY PROGRESSIVE DISEASE, IN ADULTS USING A DOSE TITRATION SCHEDULE FOLLOWED BY A MAINTENANCE DOSE |
| 20MG | PONVORY | VANDA PHARMS INC | N213498 | March 18, 2021 | RX | TABLET | ORAL | 10220023 | Dec. 10, 2035 | TREATMENT OF RELAPSING FORMS OF MULTIPLE SCLEROSIS (MS), TO INCLUDE CLINICALLY ISOLATED SYNDROME, RELAPSING-REMITTING DISEASE, AND ACTIVE SECONDARY PROGRESSIVE DISEASE, IN ADULTS USING A DOSE TITRATION SCHEDULE FOLLOWED BY A MAINTENANCE DOSE |
| 20MG | PONVORY | VANDA PHARMS INC | N213498 | March 18, 2021 | RX | TABLET | ORAL | 12336980 | Dec. 10, 2035 | TREATMENT OF RELAPSING FORMS OF MULTIPLE SCLEROSIS (MS), TO INCLUDE CLINICALLY ISOLATED SYNDROME, RELAPSING-REMITTING DISEASE, AND ACTIVE SECONDARY PROGRESSIVE DISEASE, IN ADULTS USING A DOSE TITRATION SCHEDULE FOLLOWED BY A MAINTENANCE DOSE |
| 2MG | PONVORY | VANDA PHARMS INC | N213498 | March 18, 2021 | RX | TABLET | ORAL | 10220023 | Dec. 10, 2035 | TREATMENT OF RELAPSING FORMS OF MULTIPLE SCLEROSIS (MS), TO INCLUDE CLINICALLY ISOLATED SYNDROME, RELAPSING-REMITTING DISEASE, AND ACTIVE SECONDARY PROGRESSIVE DISEASE, IN ADULTS USING A DOSE TITRATION SCHEDULE FOLLOWED BY A MAINTENANCE DOSE |
| 2MG | PONVORY | VANDA PHARMS INC | N213498 | March 18, 2021 | RX | TABLET | ORAL | 12336980 | Dec. 10, 2035 | TREATMENT OF RELAPSING FORMS OF MULTIPLE SCLEROSIS (MS), TO INCLUDE CLINICALLY ISOLATED SYNDROME, RELAPSING-REMITTING DISEASE, AND ACTIVE SECONDARY PROGRESSIVE DISEASE, IN ADULTS USING A DOSE TITRATION SCHEDULE FOLLOWED BY A MAINTENANCE DOSE |
| 3MG | PONVORY | VANDA PHARMS INC | N213498 | March 18, 2021 | RX | TABLET | ORAL | 10220023 | Dec. 10, 2035 | TREATMENT OF RELAPSING FORMS OF MULTIPLE SCLEROSIS (MS), TO INCLUDE CLINICALLY ISOLATED SYNDROME, RELAPSING-REMITTING DISEASE, AND ACTIVE SECONDARY PROGRESSIVE DISEASE, IN ADULTS USING A DOSE TITRATION SCHEDULE FOLLOWED BY A MAINTENANCE DOSE |
| 3MG | PONVORY | VANDA PHARMS INC | N213498 | March 18, 2021 | RX | TABLET | ORAL | 12336980 | Dec. 10, 2035 | TREATMENT OF RELAPSING FORMS OF MULTIPLE SCLEROSIS (MS), TO INCLUDE CLINICALLY ISOLATED SYNDROME, RELAPSING-REMITTING DISEASE, AND ACTIVE SECONDARY PROGRESSIVE DISEASE, IN ADULTS USING A DOSE TITRATION SCHEDULE FOLLOWED BY A MAINTENANCE DOSE |
| 4MG | PONVORY | VANDA PHARMS INC | N213498 | March 18, 2021 | RX | TABLET | ORAL | 10220023 | Dec. 10, 2035 | TREATMENT OF RELAPSING FORMS OF MULTIPLE SCLEROSIS (MS), TO INCLUDE CLINICALLY ISOLATED SYNDROME, RELAPSING-REMITTING DISEASE, AND ACTIVE SECONDARY PROGRESSIVE DISEASE, IN ADULTS USING A DOSE TITRATION SCHEDULE FOLLOWED BY A MAINTENANCE DOSE |
| 4MG | PONVORY | VANDA PHARMS INC | N213498 | March 18, 2021 | RX | TABLET | ORAL | 12336980 | Dec. 10, 2035 | TREATMENT OF RELAPSING FORMS OF MULTIPLE SCLEROSIS (MS), TO INCLUDE CLINICALLY ISOLATED SYNDROME, RELAPSING-REMITTING DISEASE, AND ACTIVE SECONDARY PROGRESSIVE DISEASE, IN ADULTS USING A DOSE TITRATION SCHEDULE FOLLOWED BY A MAINTENANCE DOSE |
| 5MG | PONVORY | VANDA PHARMS INC | N213498 | March 18, 2021 | RX | TABLET | ORAL | 10220023 | Dec. 10, 2035 | TREATMENT OF RELAPSING FORMS OF MULTIPLE SCLEROSIS (MS), TO INCLUDE CLINICALLY ISOLATED SYNDROME, RELAPSING-REMITTING DISEASE, AND ACTIVE SECONDARY PROGRESSIVE DISEASE, IN ADULTS USING A DOSE TITRATION SCHEDULE FOLLOWED BY A MAINTENANCE DOSE |
| 5MG | PONVORY | VANDA PHARMS INC | N213498 | March 18, 2021 | RX | TABLET | ORAL | 12336980 | Dec. 10, 2035 | TREATMENT OF RELAPSING FORMS OF MULTIPLE SCLEROSIS (MS), TO INCLUDE CLINICALLY ISOLATED SYNDROME, RELAPSING-REMITTING DISEASE, AND ACTIVE SECONDARY PROGRESSIVE DISEASE, IN ADULTS USING A DOSE TITRATION SCHEDULE FOLLOWED BY A MAINTENANCE DOSE |
| 6MG | PONVORY | VANDA PHARMS INC | N213498 | March 18, 2021 | RX | TABLET | ORAL | 10220023 | Dec. 10, 2035 | TREATMENT OF RELAPSING FORMS OF MULTIPLE SCLEROSIS (MS), TO INCLUDE CLINICALLY ISOLATED SYNDROME, RELAPSING-REMITTING DISEASE, AND ACTIVE SECONDARY PROGRESSIVE DISEASE, IN ADULTS USING A DOSE TITRATION SCHEDULE FOLLOWED BY A MAINTENANCE DOSE |
| 6MG | PONVORY | VANDA PHARMS INC | N213498 | March 18, 2021 | RX | TABLET | ORAL | 12336980 | Dec. 10, 2035 | TREATMENT OF RELAPSING FORMS OF MULTIPLE SCLEROSIS (MS), TO INCLUDE CLINICALLY ISOLATED SYNDROME, RELAPSING-REMITTING DISEASE, AND ACTIVE SECONDARY PROGRESSIVE DISEASE, IN ADULTS USING A DOSE TITRATION SCHEDULE FOLLOWED BY A MAINTENANCE DOSE |
| 7MG | PONVORY | VANDA PHARMS INC | N213498 | March 18, 2021 | RX | TABLET | ORAL | 10220023 | Dec. 10, 2035 | TREATMENT OF RELAPSING FORMS OF MULTIPLE SCLEROSIS (MS), TO INCLUDE CLINICALLY ISOLATED SYNDROME, RELAPSING-REMITTING DISEASE, AND ACTIVE SECONDARY PROGRESSIVE DISEASE, IN ADULTS USING A DOSE TITRATION SCHEDULE FOLLOWED BY A MAINTENANCE DOSE |
| 7MG | PONVORY | VANDA PHARMS INC | N213498 | March 18, 2021 | RX | TABLET | ORAL | 12336980 | Dec. 10, 2035 | TREATMENT OF RELAPSING FORMS OF MULTIPLE SCLEROSIS (MS), TO INCLUDE CLINICALLY ISOLATED SYNDROME, RELAPSING-REMITTING DISEASE, AND ACTIVE SECONDARY PROGRESSIVE DISEASE, IN ADULTS USING A DOSE TITRATION SCHEDULE FOLLOWED BY A MAINTENANCE DOSE |
| 8MG | PONVORY | VANDA PHARMS INC | N213498 | March 18, 2021 | RX | TABLET | ORAL | 10220023 | Dec. 10, 2035 | TREATMENT OF RELAPSING FORMS OF MULTIPLE SCLEROSIS (MS), TO INCLUDE CLINICALLY ISOLATED SYNDROME, RELAPSING-REMITTING DISEASE, AND ACTIVE SECONDARY PROGRESSIVE DISEASE, IN ADULTS USING A DOSE TITRATION SCHEDULE FOLLOWED BY A MAINTENANCE DOSE |
| 8MG | PONVORY | VANDA PHARMS INC | N213498 | March 18, 2021 | RX | TABLET | ORAL | 12336980 | Dec. 10, 2035 | TREATMENT OF RELAPSING FORMS OF MULTIPLE SCLEROSIS (MS), TO INCLUDE CLINICALLY ISOLATED SYNDROME, RELAPSING-REMITTING DISEASE, AND ACTIVE SECONDARY PROGRESSIVE DISEASE, IN ADULTS USING A DOSE TITRATION SCHEDULE FOLLOWED BY A MAINTENANCE DOSE |
| 9MG | PONVORY | VANDA PHARMS INC | N213498 | March 18, 2021 | RX | TABLET | ORAL | 10220023 | Dec. 10, 2035 | TREATMENT OF RELAPSING FORMS OF MULTIPLE SCLEROSIS (MS), TO INCLUDE CLINICALLY ISOLATED SYNDROME, RELAPSING-REMITTING DISEASE, AND ACTIVE SECONDARY PROGRESSIVE DISEASE, IN ADULTS USING A DOSE TITRATION SCHEDULE FOLLOWED BY A MAINTENANCE DOSE |
| 9MG | PONVORY | VANDA PHARMS INC | N213498 | March 18, 2021 | RX | TABLET | ORAL | 12336980 | Dec. 10, 2035 | TREATMENT OF RELAPSING FORMS OF MULTIPLE SCLEROSIS (MS), TO INCLUDE CLINICALLY ISOLATED SYNDROME, RELAPSING-REMITTING DISEASE, AND ACTIVE SECONDARY PROGRESSIVE DISEASE, IN ADULTS USING A DOSE TITRATION SCHEDULE FOLLOWED BY A MAINTENANCE DOSE |
| 10MG | PONVORY | VANDA PHARMS INC | N213498 | March 18, 2021 | RX | TABLET | ORAL | 11951097 | Oct. 10, 2042 | TREATMENT OF RELAPSING FORMS OF MULTIPLE SCLEROSIS (MS), TO INCLUDE CLINICALLY ISOLATED SYNDROME, RELAPSING-REMITTING DISEASE, AND ACTIVE SECONDARY PROGRESSIVE DISEASE, IN ADULTS BEING TREATED WITH A BETA-BLOCKER OR IN ADULTS REINITIATING TREATMENT |
| 20MG | PONVORY | VANDA PHARMS INC | N213498 | March 18, 2021 | RX | TABLET | ORAL | 11951097 | Oct. 10, 2042 | TREATMENT OF RELAPSING FORMS OF MULTIPLE SCLEROSIS (MS), TO INCLUDE CLINICALLY ISOLATED SYNDROME, RELAPSING-REMITTING DISEASE, AND ACTIVE SECONDARY PROGRESSIVE DISEASE, IN ADULTS BEING TREATED WITH A BETA-BLOCKER OR IN ADULTS REINITIATING TREATMENT |
| 2MG | PONVORY | VANDA PHARMS INC | N213498 | March 18, 2021 | RX | TABLET | ORAL | 11951097 | Oct. 10, 2042 | TREATMENT OF RELAPSING FORMS OF MULTIPLE SCLEROSIS (MS), TO INCLUDE CLINICALLY ISOLATED SYNDROME, RELAPSING-REMITTING DISEASE, AND ACTIVE SECONDARY PROGRESSIVE DISEASE, IN ADULTS BEING TREATED WITH A BETA-BLOCKER OR IN ADULTS REINITIATING TREATMENT |
| 3MG | PONVORY | VANDA PHARMS INC | N213498 | March 18, 2021 | RX | TABLET | ORAL | 11951097 | Oct. 10, 2042 | TREATMENT OF RELAPSING FORMS OF MULTIPLE SCLEROSIS (MS), TO INCLUDE CLINICALLY ISOLATED SYNDROME, RELAPSING-REMITTING DISEASE, AND ACTIVE SECONDARY PROGRESSIVE DISEASE, IN ADULTS BEING TREATED WITH A BETA-BLOCKER OR IN ADULTS REINITIATING TREATMENT |
| 4MG | PONVORY | VANDA PHARMS INC | N213498 | March 18, 2021 | RX | TABLET | ORAL | 11951097 | Oct. 10, 2042 | TREATMENT OF RELAPSING FORMS OF MULTIPLE SCLEROSIS (MS), TO INCLUDE CLINICALLY ISOLATED SYNDROME, RELAPSING-REMITTING DISEASE, AND ACTIVE SECONDARY PROGRESSIVE DISEASE, IN ADULTS BEING TREATED WITH A BETA-BLOCKER OR IN ADULTS REINITIATING TREATMENT |
| 5MG | PONVORY | VANDA PHARMS INC | N213498 | March 18, 2021 | RX | TABLET | ORAL | 11951097 | Oct. 10, 2042 | TREATMENT OF RELAPSING FORMS OF MULTIPLE SCLEROSIS (MS), TO INCLUDE CLINICALLY ISOLATED SYNDROME, RELAPSING-REMITTING DISEASE, AND ACTIVE SECONDARY PROGRESSIVE DISEASE, IN ADULTS BEING TREATED WITH A BETA-BLOCKER OR IN ADULTS REINITIATING TREATMENT |
| 6MG | PONVORY | VANDA PHARMS INC | N213498 | March 18, 2021 | RX | TABLET | ORAL | 11951097 | Oct. 10, 2042 | TREATMENT OF RELAPSING FORMS OF MULTIPLE SCLEROSIS (MS), TO INCLUDE CLINICALLY ISOLATED SYNDROME, RELAPSING-REMITTING DISEASE, AND ACTIVE SECONDARY PROGRESSIVE DISEASE, IN ADULTS BEING TREATED WITH A BETA-BLOCKER OR IN ADULTS REINITIATING TREATMENT |
| 7MG | PONVORY | VANDA PHARMS INC | N213498 | March 18, 2021 | RX | TABLET | ORAL | 11951097 | Oct. 10, 2042 | TREATMENT OF RELAPSING FORMS OF MULTIPLE SCLEROSIS (MS), TO INCLUDE CLINICALLY ISOLATED SYNDROME, RELAPSING-REMITTING DISEASE, AND ACTIVE SECONDARY PROGRESSIVE DISEASE, IN ADULTS BEING TREATED WITH A BETA-BLOCKER OR IN ADULTS REINITIATING TREATMENT |
| 8MG | PONVORY | VANDA PHARMS INC | N213498 | March 18, 2021 | RX | TABLET | ORAL | 11951097 | Oct. 10, 2042 | TREATMENT OF RELAPSING FORMS OF MULTIPLE SCLEROSIS (MS), TO INCLUDE CLINICALLY ISOLATED SYNDROME, RELAPSING-REMITTING DISEASE, AND ACTIVE SECONDARY PROGRESSIVE DISEASE, IN ADULTS BEING TREATED WITH A BETA-BLOCKER OR IN ADULTS REINITIATING TREATMENT |
| 9MG | PONVORY | VANDA PHARMS INC | N213498 | March 18, 2021 | RX | TABLET | ORAL | 11951097 | Oct. 10, 2042 | TREATMENT OF RELAPSING FORMS OF MULTIPLE SCLEROSIS (MS), TO INCLUDE CLINICALLY ISOLATED SYNDROME, RELAPSING-REMITTING DISEASE, AND ACTIVE SECONDARY PROGRESSIVE DISEASE, IN ADULTS BEING TREATED WITH A BETA-BLOCKER OR IN ADULTS REINITIATING TREATMENT |
Orange Book exclusivity data (new drug applications)
| Formulation strength | Trade name | Applicant | Application number | Approval date | Type | Dose form | Route | Exclusivity date | Description |
|---|---|---|---|---|---|---|---|---|---|
| 10MG | PONVORY | VANDA PHARMS INC | N213498 | March 18, 2021 | RX | TABLET | ORAL | March 18, 2026 | NEW CHEMICAL ENTITY |
| 20MG | PONVORY | VANDA PHARMS INC | N213498 | March 18, 2021 | RX | TABLET | ORAL | March 18, 2026 | NEW CHEMICAL ENTITY |
| 2MG | PONVORY | VANDA PHARMS INC | N213498 | March 18, 2021 | RX | TABLET | ORAL | March 18, 2026 | NEW CHEMICAL ENTITY |
| 3MG | PONVORY | VANDA PHARMS INC | N213498 | March 18, 2021 | RX | TABLET | ORAL | March 18, 2026 | NEW CHEMICAL ENTITY |
| 4MG | PONVORY | VANDA PHARMS INC | N213498 | March 18, 2021 | RX | TABLET | ORAL | March 18, 2026 | NEW CHEMICAL ENTITY |
| 5MG | PONVORY | VANDA PHARMS INC | N213498 | March 18, 2021 | RX | TABLET | ORAL | March 18, 2026 | NEW CHEMICAL ENTITY |
| 6MG | PONVORY | VANDA PHARMS INC | N213498 | March 18, 2021 | RX | TABLET | ORAL | March 18, 2026 | NEW CHEMICAL ENTITY |
| 7MG | PONVORY | VANDA PHARMS INC | N213498 | March 18, 2021 | RX | TABLET | ORAL | March 18, 2026 | NEW CHEMICAL ENTITY |
| 8MG | PONVORY | VANDA PHARMS INC | N213498 | March 18, 2021 | RX | TABLET | ORAL | March 18, 2026 | NEW CHEMICAL ENTITY |
| 9MG | PONVORY | VANDA PHARMS INC | N213498 | March 18, 2021 | RX | TABLET | ORAL | March 18, 2026 | NEW CHEMICAL ENTITY |
Bioactivity Summary:
| Target | Class | Pharos | UniProt | Action | Type | Activity value (-log[M]) | Mechanism action | Bioact source | MoA source |
|---|---|---|---|---|---|---|---|---|---|
| Sphingosine 1-phosphate receptor 1 | GPCR | AGONIST | EC50 | 8.13 | SCIENTIFIC LITERATURE | DRUG LABEL | |||
| Sphingosine 1-phosphate receptor 5 | GPCR | AGONIST | EC50 | 7.23 | SCIENTIFIC LITERATURE | ||||
| Sphingosine 1-phosphate receptor 4 | GPCR | AGONIST | EC50 | 5.96 | SCIENTIFIC LITERATURE | ||||
| Sphingosine 1-phosphate receptor 3 | GPCR | AGONIST | EC50 | 6.94 | SCIENTIFIC LITERATURE |
External reference:
| ID | Source |
|---|---|
| D11215 | KEGG_DRUG |
| 5G7AKV2MKP | UNII |
| C2934701 | UMLSCUI |
| CHEBI:233412 | CHEBI |
| CHEMBL1096146 | ChEMBL_ID |
| 11363176 | PUBCHEM_CID |
| DB12016 | DRUGBANK_ID |
| 9150 | INN_ID |
| C550169 | MESH_SUPPLEMENTAL_RECORD_UI |
| 9320 | IUPHAR_LIGAND_ID |
| 1179253008 | SNOMEDCT_US |
| 1179254002 | SNOMEDCT_US |
| 4040289 | VANDF |
| 344652 | MMSL |
| 39406 | MMSL |
| d09723 | MMSL |
| 018671 | NDDF |
| 2532300 | RXNORM |
| 5G7AKV2MKP | INXIGHT DRUGS |
Pharmaceutical products:
| Product | Category | Ingredients | NDC | Form | Quantity | Route | Marketing | Label |
|---|---|---|---|---|---|---|---|---|
| PONVORY | HUMAN PRESCRIPTION DRUG LABEL | 1 | 43068-620 | TABLET, FILM COATED | 20 mg | ORAL | NDA | 29 sections |
| PONVORY | HUMAN PRESCRIPTION DRUG LABEL | 1 | 50458-720 | TABLET, FILM COATED | 20 mg | ORAL | NDA | 32 sections |