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rizatriptan benzoate (MK0462)
rizatriptan benzoate (MK0462) is a Serotonin receptor agonist Small molecule drug developed by Organon and Co. It is currently in Phase 3 development for Acute treatment of migraine attacks with or without aura. Also known as: MK0462.
Rizatriptan benzoate is a selective serotonin 5-HT1B/1D receptor agonist, which is believed to relieve migraine headaches by causing vasoconstriction and inhibiting pro-inflammatory neuropeptide release.
Rizatriptan benzoate (MK0462) is a small molecule serotonin 1b (5-HT1b) receptor agonist used to treat migraine headache. It is classified as an agonist and has been studied in clinical trials for the treatment of migraine with recurrence.
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Baseline phase 3 → approval rate
+58.3pp
Industry-wide phase 3 drugs reach approval ~58.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas). -
CNS / neurology attrition
-3.0pp
CNS drugs have historically high Phase 3 failure rates (notably in Alzheimer disease + major depression).
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2028–2030 | — |
| EMA | EU | 2029–2031 | +0.7 yr |
| MHRA | GB | 2029–2031 | +0.7 yr |
| Health Canada | CA | 2029–2032 | +0.9 yr |
| TGA | AU | 2029–2032 | +1.2 yr |
| PMDA | JP | 2029–2032 | +1.5 yr |
| NMPA | CN | 2030–2033 | +2.3 yr |
| MFDS | KR | 2029–2032 | +1.4 yr |
| CDSCO | IN | 2029–2033 | +1.8 yr |
| ANVISA | BR | 2030–2033 | +2.3 yr |
Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).
Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.
At a glance
| Generic name | rizatriptan benzoate (MK0462) |
|---|---|
| Also known as | MK0462 |
| Sponsor | Organon and Co |
| Drug class | Serotonin receptor agonist |
| Target | 5-HT1B/1D receptor |
| Modality | Small molecule |
| Therapeutic area | Neurology |
| Phase | Phase 3 |
Mechanism of action
The exact mechanism of action is not fully understood, but it is thought to involve the activation of 5-HT1B and 5-HT1D receptors, leading to the inhibition of pro-inflammatory neuropeptide release and vasoconstriction. This results in the relief of migraine headache symptoms.
Approved indications
- Acute treatment of migraine attacks with or without aura
Common side effects
- Dizziness
- Headache
- Nausea
- Fatigue
- Dyspepsia
Key clinical trials
- A Comparison of Nurtec ODT to Maxalt MLT-ODT in Adult ED Patients With Migraine Headache (PHASE4)
- Study to Test a Marketed Drug in the Treatment of Menstrual Migraine (0462-072) (PHASE3)
- Study to Test an Approved Product in the Early Treatment of Migraine (0462-066) (PHASE3)
- Study to Test a Marketed Drug in the Treatment of Menstrual Migraine (0462-071) (PHASE3)
- Study to Test an Approved Product in the Early Treatment of Migraine (0462-065) (PHASE3)
- A Study of Rizatriptan for the Treatment of Acute Migraine in Patients on Topiramate for Migraine Prophylaxis (PHASE3)
- Study to Test Rizatriptan in the Early Treatment of Acute Migraine (0462-081) (PHASE3)
- A Study to Evaluate the Safety and Tolerability of Rizatriptan for Long Term Treatment of Acute Migraine in Children and Adolescents (MK-0462-086 AM3) (PHASE3)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- rizatriptan benzoate (MK0462) CI brief — competitive landscape report
- rizatriptan benzoate (MK0462) updates RSS · CI watch RSS
- Organon and Co portfolio CI
Frequently asked questions about rizatriptan benzoate (MK0462)
What is rizatriptan benzoate (MK0462)?
How does rizatriptan benzoate (MK0462) work?
What is rizatriptan benzoate (MK0462) used for?
Who makes rizatriptan benzoate (MK0462)?
Is rizatriptan benzoate (MK0462) also known as anything else?
What drug class is rizatriptan benzoate (MK0462) in?
What development phase is rizatriptan benzoate (MK0462) in?
What are the side effects of rizatriptan benzoate (MK0462)?
What does rizatriptan benzoate (MK0462) target?
Related
- Drug class: All Serotonin receptor agonist drugs
- Target: All drugs targeting 5-HT1B/1D receptor
- Manufacturer: Organon and Co — full pipeline
- Therapeutic area: All drugs in Neurology
- Indication: Drugs for Acute treatment of migraine attacks with or without aura
- Also known as: MK0462
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing