Drugs / Ponesimod
Regulatory milestones approvals, filings & regulatory actions · 4 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed multiple sclerosis 2 milestones | |||||
| Filed | US (FDA) | — | multiple sclerosis | 2020-03-18 | “Janssen Submits Ponesimod New Drug Application to the U.S. FDA” jnj.com ↗ |
| Filed | EU (EMA) | — | multiple sclerosis | 2020-03-04 | “a marketing authorisation application (MAA) to the European Medicines Agency (EMA) seeking approval for ponesimod for the treatment of adult patients with relapsing multiple...” jnj.com ↗ |
| Approved Indication not stated 2 milestones | |||||
| Approved | EU (EMA) | Ponvory | — | 2021-05-19 | europa.eu ↗ |
| Approved | US (FDA) | PONVORY | — | 2021-03-18 | fda.gov ↗ |
Trials 18
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 17 trials | ||||||
| Phase 1 | NCT05552196 | Oct 2022 → Mar 2023 | — | Janssen Pharmaceutica N.V., Belgium | Completed | No outcome recorded |
| Phase 1 | NCT03882255 | Mar → Aug 2019 | — | Janssen Pharmaceutica N.V., Belgium | Completed | No outcome recorded |
| Phase 1 | NCT02068235 | Aug → Nov 2014 | — | Actelion | Completed | No outcome recorded |
| Phase 1 | NCT02136888 | Aug 2011 → Feb 2012 | — | Actelion | Completed | No outcome recorded |
| Phase 1 | NCT02029482 | Apr → Jun 2010 | — | Actelion | Completed | No outcome recorded |
| Phase 1 | NCT02126956 | Mar → Apr 2009 | — | Actelion | Completed | No outcome recorded |
| Phase 1 | NCT02223832 | Feb → Apr 2009 | — | Actelion | Completed | No outcome recorded |
| Phase 25 trials · 2 met primary | ||||||
| Phase 2 | NCT02461134 | Sep 2016 → Mar 2017 | chronic graft versus host disease | Actelion | Terminated | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT01208090 | Oct 2010 → Oct 2012 | psoriasis | Actelion | Completed | Met primary |
| Phase 2 | NCT01093326 | May 2010 → Sep 2023 | relapsing-remitting multiple sclerosis | Actelion | Completed | No outcome recorded |
| Phase 2 | NCT01006265 | Oct 2009 → Jun 2011 | relapsing-remitting multiple sclerosis | Actelion | Completed | Met primary |
| Phase 2 | NCT00852670 | Oct 2008 → Jul 2009 | psoriasis | Actelion | Completed | No outcome recorded |
| Phase 35 trials · 2 met primary · 1 missed | ||||||
| Phase 3 | NCT07686081 | Sep 2026 → Apr 2029 expected | ulcerative colitis | Vanda Pharmaceuticals | Not yet recruiting | No outcome recorded |
| Phase 3 | NCT07362017 | Feb 2026 → Aug 2028 expected | psoriasis | Vanda Pharmaceuticals | Recruiting | No outcome recorded |
| Phase 3 | NCT03232073 | Jul 2017 → Jan 2024 | multiple sclerosis | Actelion | Completed | Met primary |
| Phase 3 | NCT02907177 | Mar 2017 → Mar 2020 | multiple sclerosis | Actelion | Terminated | Missed primary Stop: Enrollment |
| Phase 3 | NCT02425644 | Jun 2015 → May 2019 | multiple sclerosis | Actelion | Completed | Met primary |
| Phase 41 trial | ||||||
| Phase 4 | NCT03535298 | Jan 2019 → Jul 2027 expected | relapsing-remitting multiple sclerosis | The Cleveland Clinic | Active not recruiting | No outcome recorded |
| Comparator or background therapy1 trial | ||||||
| Phase 2 | NCT06715605 Comparator | Apr 2025 | multiple sclerosis | University Hospital, Antwerp | Withdrawn | No outcome recorded Stop: Business |
News releases announcing trial results or a regulatory action · 14
| Date | Issuer | Release |
|---|---|---|
| 2021-10-13 | Janssen Research & Development, LLC | Results New Subgroup Analysis of the Phase 3 OPTIMUM Study Demonstrates the Benefits of PONVORYTM (ponesimod) Over teriflunomide in Early Disease Multiple Sclerosis jnj.com ↗ |
| 2021-05-24 | Janssen Research & Development, LLC | Regulatory European Commission approves PONVORYTM (ponesimod), a Once Daily, Oral Therapy for the Treatment of Adults with Relapsing Forms of Multiple Sclerosis with Active Disease Defined by Clinical or Imaging Features jnj.com ↗
I welcome the European Commission’s approval of ponesimod as an additional treatment option for those living with relapsing multiple sclerosis - it will provide patients with additional choice when making decisions about their treatment. |
| 2021-05-24 | Janssen Research & Development, LLC | Regulatory European Commission approves PONVORYTM (ponesimod), a Once Daily, Oral Therapy for the Treatment of Adults with Relapsing Forms of Multiple Sclerosis with Active Disease Defined by Clinical or Imaging Features jnj.com ↗ |
| 2021-03-26 | Janssen Research & Development, LLC | Regulatory Janssen Receives Positive CHMP Opinion for PONVORY™ (ponesimod) for the Treatment of Adults With Relapsing Forms of Multiple Sclerosis With Active Disease Defined by Clinical or Imaging Features jnj.com ↗
The Janssen Pharmaceutical Companies of Johnson & Johnson announced today that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion recommending marketing authorisation for PONVORY™(ponesimod) for the treatment of adult patients with relapsing multiple sclerosis (RMS) with active disease defined by clinical or imaging features. |
| 2021-03-26 | Janssen Research & Development, LLC | Regulatory Janssen Receives Positive CHMP Opinion for PONVORY™ (ponesimod) for the Treatment of Adults With Relapsing Forms of Multiple Sclerosis With Active Disease Defined by Clinical or Imaging Features jnj.com ↗
Janssen Receives Positive CHMP Opinion for PONVORY™ (ponesimod) for the Treatment of Adults With Relapsing Forms of Multiple Sclerosis With Active Disease Defined by Clinical or Imaging Features |
| 2021-03-19 | Janssen Research & Development, LLC | Regulatory Janssen Announces U.S. FDA Approval of PONVORY™ (ponesimod), an Oral Treatment for Adults with Relapsing Multiple Sclerosis Proven Superior to Aubagio® (teriflunomide) in Reducing Annual Relapses and Brain Lesions jnj.com ↗ |
| 2021-03-19 | Janssen Research & Development, LLC | Regulatory Janssen Announces U.S. FDA Approval of PONVORY™ (ponesimod), an Oral Treatment for Adults with Relapsing Multiple Sclerosis Proven Superior to Aubagio® (teriflunomide) in Reducing Annual Relapses and Brain Lesions jnj.com ↗
Janssen Announces U.S. FDA Approval of PONVORY™ (ponesimod), an Oral Treatment for Adults with Relapsing Multiple Sclerosis Proven Superior to Aubagio® (teriflunomide) in Reducing Annual Relapses and Brain Lesions |
| 2020-09-02 | Janssen Research & Development, LLC | Results Janssen to Present Latest Research in Multiple Sclerosis at MSVirtual2020: 8th Joint ACTRIMS-ECTRIMS Meeting jnj.com ↗ |
| 2020-03-18 | Janssen Research & Development, LLC | Regulatory Janssen Submits Ponesimod New Drug Application to the U.S. FDA for Treatment of Adults with Relapsing Multiple Sclerosis jnj.com ↗
The Janssen Pharmaceutical Companies of Johnson & Johnson (Janssen) today announced the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for ponesimod for the treatment of adult patients with relapsing multiple sclerosis (MS). |
| 2020-03-04 | Janssen Research & Development, LLC | Regulatory Janssen Submits European Marketing Authorisation Application for Ponesimod for Treatment of Adults with Relapsing Multiple Sclerosis jnj.com ↗ |
| 2019-09-11 | Janssen Research & Development, LLC | Results New Head-to-Head Phase 3 Study Data Show Ponesimod Superiority Versus Aubagio® (teriflunomide) 14 mg in Adults with Relapsing Multiple Sclerosis (MS) jnj.com ↗
Notably, we saw superiority of the investigational agent ponesimod when compared to teriflunomide across the primary and most secondary endpoints. |
| 2019-09-11 | Janssen Research & Development, LLC | Results New Head-to-Head Phase 3 Study Data Show Ponesimod Superiority Versus Aubagio® (teriflunomide) 14 mg in Adults with Relapsing Multiple Sclerosis (MS) jnj.com ↗
New Head-to-Head Phase 3 Study Data Show Ponesimod Superiority Versus Aubagio® (teriflunomide) 14 mg in Adults with Relapsing Multiple Sclerosis (MS) |
| 2019-07-25 | Janssen Research & Development, LLC | Results Janssen reports positive top-line Phase 3 results for ponesimod in adults with relapsing multiple sclerosis jnj.com ↗
The Janssen Pharmaceutical Companies of Johnson & Johnson today announced positive top-line results from the Phase 3 OPTIMUM study, which evaluated the efficacy and safety of ponesimod compared to Aubagio®*(teriflunomide) in adults with relapsing multiple sclerosis. |
| 2019-07-25 | Janssen Research & Development, LLC | Results Janssen reports positive top-line Phase 3 results for ponesimod in adults with relapsing multiple sclerosis jnj.com ↗
The study met its primary and most secondary endpoints. |
All press releases naming this drug 20 releases
Evidence & citations 8 cited values
Every value below carries the sentence it was read from. 21 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | ponesimod | “OBJECTIVE: This double-blind, placebo-controlled, dose-finding phase IIb study evaluated the efficacy and safety of ponesimod, an oral selective S1P1 receptor modulator, for...” PMID 24659797 ↗ Mar 201414“Standard-of-care on first-line treatment such as interferon-beta, glatiramer acetate, teriflunomide, dimethylfumarate, ponesimod and ozanimod.” NCT06715605 ↗ “Oral ponesimod in patients with chronic plaque psoriasis: a randomised, double-blind, placebo-controlled phase 2 trial.” PMID 25127208 ↗ Aug 2014 “Ponvory (ponesimod)” NCT03535298 ↗ |
| Known as | ACT-128800 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT02029482 ↗ |
| Known as | Ponvory | ChEMBL registry synonym — accepted as the source's own label CHEMBL1096146 ↗ |
| Known as | Ponvory (ponesimod) | “Ponvory (ponesimod)” NCT03535298 ↗ |
| Action | Activate | “ACT-128800, an S1P1 Receptor Agonist” NCT00852670 ↗ |
| Modality | Small molecule | — CHEMBL1096146 ↗ |
| Route | Oral | “ACT-128800 administered orally once daily” NCT00852670 ↗ |
| Target | S1PR1 | “sphingosine-1-phosphate receptor 1 (S1P1) modulator” PMID 33779698 ↗ May 2021 |