Rizafilm

(rizatriptan benzoate)

ApprovedSmall molecule

OOrganon and Co

Indications

Total Trials

Active Trials

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Timeline

Expected Milestones

Q4 2026

Post-ApprovalRecruiting

Headache

NCT06473597

Clinical

Trials by Indication[1]

Migraine5 trials

Treatment of Multiple Attacks of Acute Migraine (0462-025)

Completed·OOrganon and Co·Phase 3·NCT00899379·473 enrolled

MK0462 in Treatment of Migraine With Recurrence (MK0462-022)

Completed·OOrganon and Co·Phase 3·NCT00897949·1,473 enrolled

Drug Study in Pediatric Subjects With Migraines (MK0462-083 AM1)

Completed·OOrganon and Co·Phase 1·NCT00604812·31 enrolled

Show 2 more trials

A Study of Rizatriptan for the Treatment of Acute Migraine in Patients on Topiramate for Migraine Prophylaxis

Completed·OOrganon and Co·Phase 3·NCT00812006·108 enrolled

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)

Completed·OOrganon and Co·Phase 3·NCT01004263·674 enrolled

MPA2 trials

MK0462 5 mg, Sumatriptan 50 mg, and Placebo Comparison Study (0462-029)

Completed·OOrganon and Co·Phase 3·NCT00897104·933 enrolled

Rizatriptan 5 mg and 10 mg, Sumatriptan 100 mg, and Placebo Comparison Study (0462-030)

Completed·OOrganon and Co·Phase 3·NCT00898677·1,268 enrolled

Headache1 trial

A Comparison of Nurtec ODT to Maxalt MLT-ODT in Adult ED Patients With Migraine Headache

Recruiting·AAntonios Likourezos·Phase 4·NCT06473597·80 enrolled

Regulatory

FDA Approval Timeline[4]

Jun 29, 1998

MAXALT-MLT

NDA NDA020865

Jun 29, 1998

MAXALT

NDA NDA020864

Feb 26, 2026

RIZAFILM

NDA NDA205394

Sources

References

[1]
ClinicalTrials.gov — 8 trial records for rizatriptan benzoate. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — rizatriptan benzoate compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for rizatriptan benzoate. EMBL-EBI & Wellcome Sanger Institute.
[4]
OpenFDA — FDA approval records (NDA NDA205394). U.S. Food & Drug Administration.
[5]
SEC EDGAR — Organon and Co company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Highest Phase: Approved[1]
Company: OOrganon and Co