TheraRadar
Data updated: May 26, 2026

TASCENSO ODT (fingolimod lauryl sulfate)

Trial Activity: Mature 9 active trials
CNS Approved 2021-12-23

TASCENSO ODT is indicated for the treatment of Multiple Sclerosis; Clinically Isolated Syndrome; Relapsing-Remitting Disease; Secondary Progressive Disease.

Source: FDA Label • CYCLE

How TASCENSO ODT Works

Fingolimod is metabolized into fingolimod-phosphate, an active metabolite that binds to sphingosine 1-phosphate receptors 1, 3, 4, and 5. This interaction prevents lymphocytes from leaving the lymph nodes, which reduces the number of these cells circulating in the peripheral blood. The drug's therapeutic effect in multiple sclerosis may be due to the resulting decrease in lymphocyte migration into the central nervous system.

Development Insights

Novartis Pharmaceuticals conducting 23 trials (59%)
30 indications explored (Broad Platform)
multiple sclerosis (9 trials)
relapsing-remitting multiple sclerosis (5 trials)
relapsing remitting multiple sclerosis (5 trials)
2
Indications
--
Phase 3 Trials
4
Years on Market

Details

Status
Prescription
First Approved
2021-12-23
Patent Cliff
2036

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Patent cliff and revenue data

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Routes
ORAL
Dosage Forms
TABLET, ORALLY DISINTEGRATING

Companies

Active Ingredient: FINGOLIMOD LAURYL SULFATE

TASCENSO ODT Approval History

2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
10 FDA actions from 2021 to 2025
Jan 2025 SUPPL
Label · Labeling
Jun 2024 SUPPL
Label · Labeling
Aug 2023 SUPPL
Label · Labeling

What TASCENSO ODT Treats

4 indications

TASCENSO ODT is approved for 4 conditions since its original approval in 2021. These indications span multiple therapeutic areas including oncology, immunology, and more.

  • Multiple Sclerosis
  • Clinically Isolated Syndrome
  • Relapsing-Remitting Disease
  • Secondary Progressive Disease
Source: FDA Label

TASCENSO ODT Competitive Set

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Three rings of competition based on shared molecular targets and treated indications.

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Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.

What's emerging in TASCENSO ODT's indications

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Phase 3 candidates targeting molecules with no FDA-approved drug, in indications TASCENSO ODT treats. First-in-class if their pivotal trials read out positive.

Drugs Similar to TASCENSO ODT

3 of 20

FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.

GLATIRAMER ACETATE
GLATIRAMER ACETATE
4 shared
SYNTHON PHARMS INC
Shared indications:
Multiple SclerosisClinically Isolated SyndromeRelapsing-Remitting Disease +1 more
PLEGRIDY
PEGINTERFERON BETA-1A
4 shared
Biogen
Shared indications:
Multiple SclerosisClinically Isolated SyndromeRelapsing-Remitting Disease +1 more
TERIFLUNOMIDE
TERIFLUNOMIDE
4 shared
BIOCON PHARMA
Shared indications:
Multiple SclerosisClinically Isolated SyndromeRelapsing-Remitting Disease +1 more
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Active Pipeline

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Ongoing clinical trials by development phase

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Key Completed Trials

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Completed studies with published results, ranked by significance

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Trial Timeline

Full development history with FDA approval milestones

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Understanding FDA Approval Types
Count Type What it means
- ORIG Original approval - drug first enters market
- SUPPL - Efficacy New indication (new disease/condition approved)
- SUPPL - Labeling Label text changes (warnings, dosing updates)
- SUPPL - Manufacturing Production changes (new facility)
- SUPPL - Chemistry Formulation changes (new dosage strength)

Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.

TASCENSO ODT FDA Label Details

Indications & Usage

FDA Label (PDF)

TASCENSO ODT is indicated for the treatment of Multiple Sclerosis; Clinically Isolated Syndrome; Relapsing-Remitting Disease; Secondary Progressive Disease.

View full patent landscape →
3 OB patents · 1 families · 7 international docs across 1 countries

TASCENSO ODT Patents & Exclusivity

Latest Patent: Jan 2036

Patents (3 active)

US10555902 Expires Jan 19, 2036
US9925138 Expires Jan 19, 2036
US10925829 Expires Jan 19, 2036
Source: FDA Orange Book

Pro Intelligence Preview

Deep insights for TASCENSO ODT

Revenue Insights

  • Quarterly revenue tracking
  • Historical trend analysis

Patent Timeline

  • Cliff: 2036
  • 12 active patents

Trial Analysis

  • 39 total trials
  • Stage: Mature

Competitive Landscape

  • 20 similar drugs
  • Same target/indication analysis
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Data Sources

Data sourced from official FDA and NIH databases. Click links to verify on original sources.

How We Calculate These Metrics

Trial Activity Stage

Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.

Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.

  • Growth: High proportion of early-phase trials (Phase 1/2), active development
  • Expansion: Significant Phase 3 activity, approaching or pursuing approvals
  • Mature: Substantial Phase 4 post-marketing studies
  • Stable: Mixed phase distribution, steady development
  • Declining: Low active trial ratio, reduced R&D investment