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Micardis (TELMISARTAN)
Micardis works by blocking the action of angiotensin II, a hormone that constricts blood vessels and increases blood pressure.
Telmisartan (Micardis), marketed by Boehringer Ingelheim, is an angiotensin II receptor blocker primarily indicated for hypertension, with a key composition patent expiring in 2028. Its key strength lies in its well-established market presence and ongoing patent protection, which differentiates it from off-patent competitors like eprosartan, valsartan, irbesartan, and candesartan cilexetil. The primary risk is the increasing competition from generics, particularly from drugs like valsartan and irbesartan, which have numerous generic formulations already available.
At a glance
| Generic name | TELMISARTAN |
|---|---|
| Sponsor | Boehringer Ingelheim |
| Drug class | Angiotensin 2 Receptor Blocker [EPC] |
| Target | Type-2 angiotensin II receptor |
| Modality | Small molecule |
| Therapeutic area | Metabolic |
| Phase | FDA-approved |
| First approval | 1998 |
Mechanism of action
Angiotensin II is formed from angiotensin in reaction catalyzed by angiotensin-converting enzyme (ACE, kininase II). Angiotensin II is the principal pressor agent of the reninangiotensin system, with effects that include vasoconstriction, stimulation of synthesis and release of aldosterone, cardiac stimulation, and renal reabsorption of sodium. Telmisartan blocks the vasoconstrictor and aldosterone-secreting effects of angiotensin II by selectively blocking the binding of angiotensin II to the AT1 receptor in many tissues, such as vascular smooth muscle and the adrenal gland. Its action is therefore independent of the pathways for angiotensin II synthesis.There is also an AT2 receptor found in many tissues, but AT2 is not known to be associated with cardiovascular homeostasis. Telmisartan has much greater affinity (>3,000 fold) for the AT1 receptor than for the AT2 receptor.Blockade of the renin-angiotensin system with ACE inhibitors, which inhibit the biosynt
Approved indications
- Hypertension
- Cardiovascular Risk Reduction
Boxed warnings
- WARNING: FETAL TOXICITY When pregnancy is detected, discontinue telmisartan as soon as possible [see Warnings and Precautions (5.1) and Use in Specific Populations (8.1) ]. Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus [see Warnings and Precautions (5.1) and Use in Specific Populations (8.1) ] WARNING: FETAL TOXICITY See full prescribing information for complete boxed warning. When pregnancy is detected, discontinue telmisartan as soon as possible ( 5.1 , 8.1 ) Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus ( 5.1 , 8.1 )
Common side effects
- Blood pressure increased
- Hyponatraemia
- Altered state of consciousness
- Cerebral infarction
- Head discomfort
- Pemphigus
- Interstitial lung disease
- Hyperkalaemia
- Completed suicide
- Hepatic function abnormal
- Alopecia
- Amaurosis fugax
Drug interactions
- triamterene
Key clinical trials
- Safety and Efficacy of HB-1 for PTSD: A Multi-center, Randomized, Double-Blind, Placebo-Controlled Study (PHASE2)
- Study to Evaluate the Efficacy and Safety of TEL/AML/CTD in Elderly Patients With Essential Hypertension (PHASE4)
- Telmisartan for Prevention of Doxorubicin-Induced Cardiotoxicity in Breast Cancer Patients (PHASE1,PHASE2)
- Telmisartan in Combination With Cytotoxic Regimens in Platinum-Resistant Ovarian Cancer (PHASE2)
- Efficacy and Safety of HB-1 for Panic Disorder (PHASE2)
- Association of Angiotensin-Converting Enzyme Inhibitors and Angiotensin Receptor Blockers With Post-Stroke Pneumonia: A Real-World Retrospective Cohort Study
- A Study to Investigate Efficacy and Safety of a TCA108 in Participants ≥18 Years With Uncontrolled Hypertension (PHASE3)
- Edmond J. Safra Accelerating Clinical Trials in Parkinson's Disease: A Multiarm Multi-stage Platform Trial (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 |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| 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:
- Micardis CI brief — competitive landscape report
- Micardis updates RSS · CI watch RSS
- Boehringer Ingelheim portfolio CI