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metoprolol/HCT
metoprolol/HCT is a Beta-blocker Small molecule drug developed by Abbott. It is currently in Phase 3 development for Hypertension, Atrial fibrillation for stroke prevention.
Metoprolol/HCT is a beta-blocker that works by blocking the effects of the hormone epinephrine, and also has a diuretic effect to reduce blood pressure.
Metoprolol/HCT is a beta-blocker that works by blocking the effects of the hormone epinephrine, and also has a diuretic effect to reduce blood pressure. Used for Hypertension, Atrial fibrillation for stroke prevention.
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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). -
Cardiovascular Phase 3 risk
-2.0pp
Modern cardiovascular outcome trials are large + long; many fail to beat aggressive standard-of-care.
| 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 | metoprolol/HCT |
|---|---|
| Sponsor | Abbott |
| Drug class | Beta-blocker |
| Target | Beta-1 adrenergic receptor |
| Modality | Small molecule |
| Therapeutic area | Cardiovascular |
| Phase | Phase 3 |
Mechanism of action
By blocking the effects of epinephrine, metoprolol/HCT reduces the heart rate and blood pressure, which can help to prevent heart failure and reduce the risk of stroke. The diuretic effect of HCT helps to remove excess fluid from the body, further reducing blood pressure.
Approved indications
- Hypertension
- Atrial fibrillation for stroke prevention
Common side effects
- Dizziness
- Fatigue
- Headache
- Nausea
- Diarrhea
Key clinical trials
- Fasting Study of Metoprolol Tartrate/Hydrochlorothiazide Tablets 100/50 mg and Lopressor HCT® Tablets 100/50 mg (PHASE1)
- Food Study of Metoprolol Tartrate/Hydrochlorothiazide Tablets 100/50 mg to Lopressor HCT® Tablets 100/50 mg (PHASE1)
- Action to Control Cardiovascular Risk in Diabetes (ACCORD) (PHASE3)
- Blood Pressure and Weight Trajectory on a Dual Antihypertensive Combination Plus Sibutramine Versus Placebo in Obese Hypertensives (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:
- metoprolol/HCT CI brief — competitive landscape report
- metoprolol/HCT updates RSS · CI watch RSS
- Abbott portfolio CI
Frequently asked questions about metoprolol/HCT
What is metoprolol/HCT?
How does metoprolol/HCT work?
What is metoprolol/HCT used for?
Who makes metoprolol/HCT?
What drug class is metoprolol/HCT in?
What development phase is metoprolol/HCT in?
What are the side effects of metoprolol/HCT?
What does metoprolol/HCT target?
Related
- Drug class: All Beta-blocker drugs
- Target: All drugs targeting Beta-1 adrenergic receptor
- Manufacturer: Abbott — full pipeline
- Therapeutic area: All drugs in Cardiovascular
- Indication: Drugs for Hypertension
- Indication: Drugs for Atrial fibrillation for stroke prevention
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing