NDAORALSOLUTION
Approved
Dec 2024
Lifecycle
Growth
Competitive Pressure
0/100
Data completeness
4/8 — Partial
ONTRALFY (tizanidine hydrochloride) by Biofidelity is alpha-2-adrenergic receptor agonist and presumably reduces spasticity by increasing presynaptic inhibition of motor neurons. Approved for spasticity in adults. First approved in 2024.
Drug data last refreshed 5h ago · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
ONTRALFY (tizanidine HCl) is an oral solution formulation of an alpha-2-adrenergic receptor agonist approved in December 2024 for spasticity in adults. It reduces spasticity by increasing presynaptic inhibition of motor neurons, with effects greatest on polysynaptic pathways. The drug represents a new dosage form entry into an established therapeutic category.
Growth15.8 years to LOE
Early-stage product in growth phase with no current Medicare Part D data; commercial team will focus on market capture and payer negotiations.
Mechanism of Action
alpha-2-adrenergic receptor agonist and presumably reduces spasticity by increasing presynaptic inhibition of motor neurons. The effects of tizanidine are greatest on polysynaptic pathways. The overall effect of these actions is thought to reduce facilitation of spinal motor neurons.
Indications (1)
Career Relevance
ONTRALFY offers entry-level and mid-career opportunities in a newly launched product with an established market and long patent protection. Early-stage commercial roles will focus on market education, payer negotiation, and positioning versus the entrenched ZANAFLEX franchise.
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.