drug · small molecule

ponesimod

Marketedupdated 3mo ago

by $VNDA Vanda Pharmaceuticals Inc.🔗 ChEMBL

Approved

community read0 votes

Small molecule drug with a maximum clinical stage of Approval (across all indications), with an approval for relapsing-remitting multiple sclerosis and multiple sclerosis and 3 investigational indications.

indications

investigational

IBD (Crohn's + UC)Psoriasis

targets

Sphingosine 1-phosphate receptor 1

all catalysts(0)

nothing on the calendar yet

Trials studying ponesimod

—A Study to Learn More About The Safety of Diroximel Fumarate (VUMERITY®) in Participants Who Took it During Pregnancy And About the Health of Their Babiesactive not recruitingn=1,178
phase3Open Label Study to Investigate the Safety and Efficacy of Ponesimod in Moderate-to-Severe Chronic Plaque Psoriasisnot yet recruitingn=300
phase3Long-term Extension to Study AC-058B301 to Investigate Safety, Tolerability and Disease Control of Ponesimod 20 mg in Patients With Relapsing Multiple Sclerosiscompletedn=877
phase1A Study of Ponesimod in Healthy Adult Participants Receiving Propranolol at Steady Statecompletedn=52
phase1A Study of Ponesimod in Healthy Adult Participantscompletedn=28
phase2Clinical Study to Investigate the Long-term Safety, Tolerability, and Efficacy of Ponesimod in Patients With Relapsing-remitting Multiple Sclerosiscompletedn=353
phase3Oral Ponesimod Versus Teriflunomide In Relapsing MUltiple Sclerosiscompletedn=1,133
phase2Clinical Study to Investigate the Biological Activity, Safety, Tolerability, and Pharmacokinetics of Ponesimod in Subjects With Symptomatic Chronic GVHDterminatedn=1

more trials →

Patent cliff

source: FDA Orange Book

first barrier falls

Nov 16, 2029

~3.3 years out

Earliest of all listed patents + FDA exclusivities. Generic / biosimilar entry typically only becomes possible AFTER both patent and exclusivity barriers expire.

patents (50)

Oct 10, 2042method-of-use (U-3891)US 11951097
Oct 10, 2042method-of-use (U-3891)US 11951097
Oct 10, 2042method-of-use (U-3891)US 11951097
Oct 10, 2042method-of-use (U-3891)US 11951097
Oct 10, 2042method-of-use (U-3891)US 11951097
Oct 10, 2042method-of-use (U-3891)US 11951097
Oct 10, 2042method-of-use (U-3891)US 11951097
Oct 10, 2042method-of-use (U-3891)US 11951097
Oct 10, 2042method-of-use (U-3891)US 11951097
Oct 10, 2042method-of-use (U-3891)US 11951097
Dec 10, 2035method-of-use (U-3103)US 10220023
Dec 10, 2035method-of-use (U-3103)US 10220023
Dec 10, 2035method-of-use (U-3103)US 10220023
Dec 10, 2035method-of-use (U-3103)US 10220023
Dec 10, 2035method-of-use (U-3103)US 10220023
Dec 10, 2035method-of-use (U-3103)US 10220023
Dec 10, 2035method-of-use (U-3103)US 10220023
Dec 10, 2035method-of-use (U-3103)US 10220023
Dec 10, 2035method-of-use (U-3103)US 10220023
Dec 10, 2035method-of-use (U-3103)US 10220023
Dec 10, 2035method-of-use (U-3103)US 12336980
Dec 10, 2035method-of-use (U-3103)US 12336980
Dec 10, 2035method-of-use (U-3103)US 12336980
Dec 10, 2035method-of-use (U-3103)US 12336980
Dec 10, 2035method-of-use (U-3103)US 12336980
Dec 10, 2035method-of-use (U-3103)US 12336980
Dec 10, 2035method-of-use (U-3103)US 12336980
Dec 10, 2035method-of-use (U-3103)US 12336980
Dec 10, 2035method-of-use (U-3103)US 12336980
Dec 10, 2035method-of-use (U-3103)US 12336980
May 6, 2032compositionUS 9062014
May 6, 2032compositionUS 9062014
May 6, 2032compositionUS 9062014
May 6, 2032compositionUS 9062014
May 6, 2032compositionUS 9062014
May 6, 2032compositionUS 9062014
May 6, 2032compositionUS 9062014
May 6, 2032compositionUS 9062014
May 6, 2032compositionUS 9062014
May 6, 2032compositionUS 9062014
Nov 16, 2029compositionUS RE437283.3y
Nov 16, 2029compositionUS RE437283.3y
Nov 16, 2029compositionUS RE437283.3y
Nov 16, 2029compositionUS RE437283.3y
Nov 16, 2029compositionUS RE437283.3y
Nov 16, 2029compositionUS RE437283.3y
Nov 16, 2029compositionUS RE437283.3y
Nov 16, 2029compositionUS RE437283.3y
Nov 16, 2029compositionUS RE437283.3y
Nov 16, 2029compositionUS RE437283.3y

FDA exclusivities (10)

Mar 18, 2026NCENew Chemical Entity (5y)
Mar 18, 2026NCENew Chemical Entity (5y)
Mar 18, 2026NCENew Chemical Entity (5y)
Mar 18, 2026NCENew Chemical Entity (5y)
Mar 18, 2026NCENew Chemical Entity (5y)
Mar 18, 2026NCENew Chemical Entity (5y)
Mar 18, 2026NCENew Chemical Entity (5y)
Mar 18, 2026NCENew Chemical Entity (5y)
Mar 18, 2026NCENew Chemical Entity (5y)
Mar 18, 2026NCENew Chemical Entity (5y)

News(0)

no news has mentioned this drug yet

Data sources

ClinicalTrials.gov · OpenTargets

last refreshed 47m ago

Found something off?

comments(0)

5-min edit window · permanent after that

no comments yet — first sniff?

drug · small molecule

save

ponesimod

Marketedupdated 3mo ago

by $VNDA Vanda Pharmaceuticals Inc.🔗 ChEMBL

Approved

community read0 votes

indications

investigational

IBD (Crohn's + UC)Psoriasis

targets

Sphingosine 1-phosphate receptor 1

all catalysts(0)

nothing on the calendar yet

Trials studying ponesimod

—A Study to Learn More About The Safety of Diroximel Fumarate (VUMERITY®) in Participants Who Took it During Pregnancy And About the Health of Their Babiesactive not recruitingn=1,178
phase3Open Label Study to Investigate the Safety and Efficacy of Ponesimod in Moderate-to-Severe Chronic Plaque Psoriasisnot yet recruitingn=300
phase3Long-term Extension to Study AC-058B301 to Investigate Safety, Tolerability and Disease Control of Ponesimod 20 mg in Patients With Relapsing Multiple Sclerosiscompletedn=877
phase1A Study of Ponesimod in Healthy Adult Participants Receiving Propranolol at Steady Statecompletedn=52
phase1A Study of Ponesimod in Healthy Adult Participantscompletedn=28
phase2Clinical Study to Investigate the Long-term Safety, Tolerability, and Efficacy of Ponesimod in Patients With Relapsing-remitting Multiple Sclerosiscompletedn=353
phase3Oral Ponesimod Versus Teriflunomide In Relapsing MUltiple Sclerosiscompletedn=1,133
phase2Clinical Study to Investigate the Biological Activity, Safety, Tolerability, and Pharmacokinetics of Ponesimod in Subjects With Symptomatic Chronic GVHDterminatedn=1

more trials →

Patent cliff

source: FDA Orange Book

first barrier falls

Nov 16, 2029

~3.3 years out

Earliest of all listed patents + FDA exclusivities. Generic / biosimilar entry typically only becomes possible AFTER both patent and exclusivity barriers expire.

patents (50)

Oct 10, 2042method-of-use (U-3891)US 11951097
Oct 10, 2042method-of-use (U-3891)US 11951097
Oct 10, 2042method-of-use (U-3891)US 11951097
Oct 10, 2042method-of-use (U-3891)US 11951097
Oct 10, 2042method-of-use (U-3891)US 11951097
Oct 10, 2042method-of-use (U-3891)US 11951097
Oct 10, 2042method-of-use (U-3891)US 11951097
Oct 10, 2042method-of-use (U-3891)US 11951097
Oct 10, 2042method-of-use (U-3891)US 11951097
Oct 10, 2042method-of-use (U-3891)US 11951097
Dec 10, 2035method-of-use (U-3103)US 10220023
Dec 10, 2035method-of-use (U-3103)US 10220023
Dec 10, 2035method-of-use (U-3103)US 10220023
Dec 10, 2035method-of-use (U-3103)US 10220023
Dec 10, 2035method-of-use (U-3103)US 10220023
Dec 10, 2035method-of-use (U-3103)US 10220023
Dec 10, 2035method-of-use (U-3103)US 10220023
Dec 10, 2035method-of-use (U-3103)US 10220023
Dec 10, 2035method-of-use (U-3103)US 10220023
Dec 10, 2035method-of-use (U-3103)US 10220023
Dec 10, 2035method-of-use (U-3103)US 12336980
Dec 10, 2035method-of-use (U-3103)US 12336980
Dec 10, 2035method-of-use (U-3103)US 12336980
Dec 10, 2035method-of-use (U-3103)US 12336980
Dec 10, 2035method-of-use (U-3103)US 12336980
Dec 10, 2035method-of-use (U-3103)US 12336980
Dec 10, 2035method-of-use (U-3103)US 12336980
Dec 10, 2035method-of-use (U-3103)US 12336980
Dec 10, 2035method-of-use (U-3103)US 12336980
Dec 10, 2035method-of-use (U-3103)US 12336980
May 6, 2032compositionUS 9062014
May 6, 2032compositionUS 9062014
May 6, 2032compositionUS 9062014
May 6, 2032compositionUS 9062014
May 6, 2032compositionUS 9062014
May 6, 2032compositionUS 9062014
May 6, 2032compositionUS 9062014
May 6, 2032compositionUS 9062014
May 6, 2032compositionUS 9062014
May 6, 2032compositionUS 9062014
Nov 16, 2029compositionUS RE437283.3y
Nov 16, 2029compositionUS RE437283.3y
Nov 16, 2029compositionUS RE437283.3y
Nov 16, 2029compositionUS RE437283.3y
Nov 16, 2029compositionUS RE437283.3y
Nov 16, 2029compositionUS RE437283.3y
Nov 16, 2029compositionUS RE437283.3y
Nov 16, 2029compositionUS RE437283.3y
Nov 16, 2029compositionUS RE437283.3y
Nov 16, 2029compositionUS RE437283.3y

FDA exclusivities (10)

Mar 18, 2026NCENew Chemical Entity (5y)
Mar 18, 2026NCENew Chemical Entity (5y)
Mar 18, 2026NCENew Chemical Entity (5y)
Mar 18, 2026NCENew Chemical Entity (5y)
Mar 18, 2026NCENew Chemical Entity (5y)
Mar 18, 2026NCENew Chemical Entity (5y)
Mar 18, 2026NCENew Chemical Entity (5y)
Mar 18, 2026NCENew Chemical Entity (5y)
Mar 18, 2026NCENew Chemical Entity (5y)
Mar 18, 2026NCENew Chemical Entity (5y)

News(0)

no news has mentioned this drug yet

Data sources

ClinicalTrials.gov · OpenTargets

last refreshed 47m ago

Found something off?

comments(0)

5-min edit window · permanent after that

no comments yet — first sniff?

ponesimod

indications

targets

all catalysts(0)

Trials studying ponesimod

Patent cliff

patents (50)

FDA exclusivities (10)

News(0)

Report a data issue

comments(0)

ponesimod

indications

targets

all catalysts(0)

Trials studying ponesimod

Patent cliff

patents (50)

FDA exclusivities (10)

News(0)

Report a data issue

comments(0)