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Flamboyant 200/12

EMS · Phase 3 active Small molecule Under review

Flamboyant 200/12 is a Calcium channel blocker/beta blocker combination Small molecule drug developed by EMS. It is currently in Phase 3 development for Hypertension.

Flamboyant 200/12 is a fixed-dose combination of a calcium channel blocker and a beta blocker.

Flamboyant 200/12 is a small molecule medication. It is being studied for its efficacy and safety in treating adults with moderate asthma.

Likelihood of approval
56.3% vs 58.3% industry baseline
If approved by FDA: likely 2028–2030
Steps remaining: NDA/BLA submission
Confidence: High
Why this estimate
  • 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).
  • Cardiovascular Phase 3 risk -2.0pp
    Modern cardiovascular outcome trials are large + long; many fail to beat aggressive standard-of-care.
Predicted approval windows by jurisdiction (conditional on FDA approval)
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 nameFlamboyant 200/12
SponsorEMS
Drug classCalcium channel blocker/beta blocker combination
ModalitySmall molecule
Therapeutic areaCardiovascular
PhasePhase 3

Mechanism of action

The exact mechanism of action is not well-documented, but it is believed to work by reducing blood pressure through a combination of vasodilation and decreased cardiac output.

Approved indications

Common side effects

Key clinical trials

Primary sources

Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.

SourceUsed for
ClinicalTrials.govTrial 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:

Frequently asked questions about Flamboyant 200/12

What is Flamboyant 200/12?

Flamboyant 200/12 is a Calcium channel blocker/beta blocker combination drug developed by EMS, indicated for Hypertension.

How does Flamboyant 200/12 work?

Flamboyant 200/12 is a fixed-dose combination of a calcium channel blocker and a beta blocker.

What is Flamboyant 200/12 used for?

Flamboyant 200/12 is indicated for Hypertension.

Who makes Flamboyant 200/12?

Flamboyant 200/12 is developed by EMS (see full EMS pipeline at /company/ems).

What drug class is Flamboyant 200/12 in?

Flamboyant 200/12 belongs to the Calcium channel blocker/beta blocker combination class. See all Calcium channel blocker/beta blocker combination drugs at /class/calcium-channel-blocker-beta-blocker-combination.

What development phase is Flamboyant 200/12 in?

Flamboyant 200/12 is in Phase 3.

What are the side effects of Flamboyant 200/12?

Common side effects of Flamboyant 200/12 include Edema, Dizziness, Fatigue.

Related

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing