Recent Updates
Recently added Catalysts

Rapimelt

Phase 1FDA approved 2003

Migraine | Small molecule | Neurology |AstraZeneca PLC|Trials Updated: Nov 3, 2010

Rapimelt development status

FDA approval Sep 30, 2003 as Zomig
Approval holderAmneal
ApplicationNDA021450
Highest phase Phase 1
Registered trials 1 across 1 sponsor since Mar 2010

Label indication ZOLMITRIPTAN NASAL SPRAY is indicated for the acute treatment of migraine with or without aura in adults and pediatric patients 12 years of age and older. Limitations of Use Only use ZOLMITRIPTAN NASAL SPRAY if a clear diagnosis of migraine has been established. FDA label

Rapimelt target and mechanism

ModalitySmall molecule

Also known as ZOMIG®

Success Probability

Subscribe to view

Market & Valuation

Subscribe to view

Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment10

FDA Designations

No designations recorded

Rapimelt clinical trials

Rapimelt · 1 trial · 1 indication

Phase 1 1
NCT01085123Determine Central 5-HT1B Receptor Occupancy of ZOMIG® Rapimelt (Zolmitriptan) in Healthy Male VolunteersMigraine
COMPLETED10 Analytics
PHASE1COMPLETED
Determine Central 5-HT1B Receptor Occupancy of ZOMIG® Rapimelt (Zolmitriptan) in Healthy Male Volunteers
Migraine
NCT0108512310
Unlock trial analytics

Study Endpoints

Primary Endpoints

To determine zolmitriptan and/or its active metabolite 183C91 occupancy at 5-HT1B receptors in the living human brain
The first PET measurement will serve as a baseline assessment. The second, third and fourth PET measurements will be performed after oral administration of ZOMIG® Rapimelt (10 mg, 5 mg and 2.5 mg, respectively).

Secondary Endpoints

To describe the relation between Zomig® Rapimelt dose and 5-HT1B receptor occupancy
The second, third and fourth PET measurements will be performed after oral administration of ZOMIG® Rapimelt (10 mg, 5 mg and 2.5 mg, respectively). Imaging data analysis will be performed after each PET measurement
To describe the relation between plasma concentrations of zolmitriptan and 183C91 and 5-HT1B receptor occupancy
For each of 3 visits venous blood for zolmitriptan and 183C91 PK analyses taken before drug administration and at 3 time points during PET examination: start, middle and end, ie, at 0, +30 and + 63 minutes relative to injection of the radioli
Unlock Study Endpoints

Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeBASIC_SCIENCE

Treatment Arms

ArmTypeDescription
1EXPERIMENTALPET 1: baseline, PET 2: 10 mg Zomig® Rapimelt, PET 3: 5 mg ZOMIG® Rapimelt, PET 4 2.5 mg ZOMIG® Rapimelt

Interventions

NameTypeDescription
RapimeltDRUGoral tablet , 2.5 and 5 mg, single dose. 10 mg (2x5 mg) visit 3, 5 mg visit 4, 2.5 mg visit 5.
[11C]AZ10419369DRUGsolution for iv injection. Will be injected within 2 to 5 hours after administration of ZOMIG® Rapimelt
Unlock Study Design Details

Eligibility Criteria

Age Range20 Years to 45 Years
SexMALE
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Body mass index between ≥19 and ≤30 kg/m2. Exclusion Criteria: * A history or presence of neurological, haematological, psychiatric, gastrointestinal, hepatic, pulmonary, renal disease * Use of drugs that induce the liver drug metabolising enzymes within 4 weeks before first...

Countries:Sweden
Unlock Eligibility Criteria

Competitive Landscape -Migraine 43 trials

Top 5 of 8 competitors

CompanyTickerTrialsLead PhaseDrugs
AbbVie, Inc.ABBV13PHASE3Atogepant, Ubrogepant, MEDI0618
Pfizer Inc.PFE11PHASE3Rimegepant, Zavegepant
Eli Lilly and CompanyLLY2PHASE3Galcanezumab
Amgen Inc.AMGN2PHASE3Erenumab
Evommune, Inc.EVMN1PHASE2EVO756
Unlock Competitive Intelligence

Frequently asked questions about Rapimelt

What is Rapimelt used for?

Rapimelt is an investigational small molecule being developed for the treatment of migraine. It is currently in Phase 1 clinical development and has not been approved by regulatory authorities.

What does Rapimelt target?

Rapimelt targets the 5-HT1B receptor, as indicated by a clinical trial measuring central 5-HT1B receptor occupancy. This receptor is involved in the mechanism of action for migraine treatment.

Who makes Rapimelt?

Rapimelt is being developed by AstraZeneca PLC, a biopharmaceutical company listed on the stock exchange under the ticker symbol AZN.

What phase is Rapimelt in?

Rapimelt is in Phase 1 clinical development. It is an investigational drug and has not been approved for any use.

What clinical trials is Rapimelt in?

Rapimelt has one completed Phase 1 clinical trial, identified as NCT01085123. This trial was a single-center study conducted in Sweden that assessed central 5-HT1B receptor occupancy of Rapimelt in healthy male volunteers.

Is Rapimelt the same as ZOMIG Rapimelt?

Rapimelt is also known as ZOMIG Rapimelt, as referenced in the clinical trial title. The trial evaluated ZOMIG Rapimelt (zolmitriptan) in healthy volunteers.

Explore more on BiopharmaWatch

AstraZeneca PLC (AZN)Pipeline, catalysts, financials, insiders and newsMigraine disease mapEvery company developing for Migraine, by stage and capitalFDA calendarUpcoming PDUFA dates, AdComs and approval oddsPDUFA calendarEvery scheduled FDA decision date, month by monthHistorical FDA calendarPast decisions and how the stock moved on eachCatalyst SyncUpcoming readouts and decisions, screened by runway and phaseBiotech stock screenerFilter by clinical phase, cash runway and market capDrugs A to ZEvery drug page starting with RCompanies A to ZEvery biotech and pharma company we track