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amlodipine besilate + irbesartan (DSP8153)

✓ Approved

Sumitomo Pharma Co., Ltd. · AGTR1 · Small Molecule

What is amlodipine besilate + irbesartan?

amlodipine besilate + irbesartan is a small molecule developed by Sumitomo Pharma Co., Ltd.. It is approved for therapeutic indications via oral (po).

Drug Profile

Brand NamesDSP8153
CompanySumitomo Pharma Co., Ltd.
Drug ClassSmall Molecule
Molecular TargetAGTR1, CACNA1C
RouteOral (PO)
StatusApproved
Sources: ClinicalTrials.gov, Sumitomo Pharma Co., Ltd.

Mechanism of Action

Molecular Targets

amlodipine besilate + irbesartan acts on 2 molecular targets:

AGTR1angiotensin II receptor type 1 (HAT1R, AT1)
CACNA1Ccalcium voltage-gated channel subunit alpha1 C (CACNL1A1, CACNA1C-IT2)
Want deeper analysis?Noah AI can explain complex mechanisms and compare to similar drugs.

Therapeutic Indications

amlodipine besilate + irbesartan is developed for 1 unique indication across 1 therapeutic area.

Therapeutic AreaConditionPhase
Vascular disordersHypertension✓ Approved

Related Research Articles

PubMedThe American journal of emergency medicine2026-09-04

Absence of hyperdynamic contractility in the setting of amlodipine-induced shock.

Bleifuss William J WJ, Olives Travis D TD, Carlson Greta Kreider GK, Cole Jon B JB

Amlodipine is a commonly prescribed antihypertensive, and among the calcium channel blockers is associated with the most fatalities in the United States. Vasoplegic shock secondary to dihydropyridine overdose is typically managed with intravenous fluids, calcium replacement and vasopressors. While high dose insulin (HDI) has established efficacy in non-dihydropyridine calcium channel blocker induced cardiogenic shock, utility in amlodipine toxicity remains controversial.

PMID 42697099
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PubMedHypertension research : official journal of the Japanese Society of Hypertension2026-09-04

Effect of sacubitril/valsartan on serum uric acid and blood pressure in patients with hypertension and asymptomatic hyperuricemia: A randomized clinical trial.

Wu Meng-Bo MB, Yang Jiao J, Ding Cong-Cong CC, Xiong Hong-Liang HL et al.

Hyperuricemia commonly coexists with hypertension and is associated with increased renal and cardiovascular risk, yet few antihypertensive agents lower serum uric acid. This study compared the urate-lowering effects of sacubitril/valsartan versus valsartan in adults with primary hypertension and asymptomatic hyperuricemia. This single-center, prospective, randomized, open-label clinical trial enrolled adults with mild-to-moderate primary hypertension and fasting serum uric acid ≥ 420 μmol/L from September 2021 to December 2024, with 12 weeks of follow-up. Participants were randomized 1:1 to sacubitril/valsartan 200 mg once daily or valsartan 160 mg once daily. A standardized stepwise add-on protocol with amlodipine was used to achieve blood pressure control. The primary outcome was the change in fasting serum uric acid from baseline to week 12. In the primary intention-to-treat analysis using multiple imputation, treatment-effect estimates were pooled across imputed datasets using Rubin's rules. In the fully adjusted model, sacubitril/valsartan was associated with a greater reduction in serum uric acid at week 12 than valsartan (β = 30.13 μmol/L; 95% CI, 4.33-55.92; P = 0.022). Similar findings were observed in the per-protocol analysis. Blood pressure control at week 12 was comparable between treatment groups, although more participants assigned to valsartan required escalation to amlodipine 10 mg than those assigned to sacubitril/valsartan (17/75 [22.67%] vs. 4/75 [5.33%]; P = 0.008). In adults with primary hypertension and asymptomatic hyperuricemia, sacubitril/valsartan was associated with greater serum uric acid reduction than valsartan over 12 weeks while achieving comparable blood pressure control. These findings suggest that sacubitril/valsartan may have a favorable uric acid profile among hypertensive patients with asymptomatic hyperuricemia. Trial Registration Chinese Clinical Trial Registry: ChiCTR2100050320 ( https://www.chictr.org.cn ). Date of Registration: September 1, 2021.

PMID 42693259
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PubMedObstetric medicine2026-09-03

Use of amlodipine to treat postpartum hypertension.

Gerretsen Hannah H, Nana Melanie M, Nelson-Piercy Catherine C

Hypertension can arise de novo or persist in the postnatal period. Limited data exist regarding the use of amlodipine in the postpartum period. A service evaluation of women prescribed amlodipine postnatally in the maternity department at Guy's and St Thomas' NHS Foundation Trust from April to November 2020 was conducted. Data were obtained by reviewing hospital records and conducting a telephone survey. Of the 100 women who were prescribed postnatal amlodipine, 43 completed the telephone survey and were included in the analysis. There were no stillbirths, neonatal deaths or significant congenital malformations. Duration of treatment varied from less than 1 week to 1 year postpartum. None of the women taking amlodipine during breastfeeding reported any problems: 23/43 (53.5%) exclusively breastfed and 10/43 (23.3%) mixed-fed. We report the largest case series of postpartum amlodipine use, providing reassuring data regarding its safety and efficacy in this population.

PMID 42688579
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PubMedFrontiers in oncology2026-09-03

Case Report: SMART syndrome mimicking Todd's paralysis after meningioma irradiation.

Troidle Anneliese A, Zhao Danzhu D, Rutter Charles C, Knopf Lisa L et al.

Stroke-like Migraine Attacks after Radiation Therapy (SMART) syndrome is a rare, delayed complication of cerebral irradiation characterized by stroke-like symptoms, seizures, and/or headaches, with mean latency period of 11.2 years. It is most associated with gliomas and medulloblastomas and diagnosis is challenging due to symptom overlap with recurrent neurologic deficits. We present a 59-year-old male with history of right frontal convexity anaplastic meningioma complicated by seizure disorder and Todd's paralysis, status post tumor resection, adjuvant radiation to 6000cGy, craniotomy and cranioplasty complicated by subdural abscess/empyema. Four years later, he presented with an epileptic seizure followed by progressive left facial and hand numbness with facial droop over 24 hours. Vitals, blood work, lumbar puncture and head computed tomography (CT) were unremarkable. CT angiography demonstrated asymmetric gyral enhancement and sulcal effacement within the right frontal lobe. Brain magnetic resonance imaging (MRI) demonstrated right hemispheric sulcal enhancement within the prior radiation field with cortical/leptomeningeal FLAIR hyperintensity and subtle diffusion restriction Electroencephalography revealed nonspecific right temporal and paracentral lateralized rhythmic discharges. Following multidisciplinary evaluation, the patient required a prolonged dexamethasone taper due to failed initial steroid taper and was initiated on amlodipine with continuation of levetiracetam, zonisamide, and clobazam. MRI at three months showed enhancement resolution with clinical improvement and no recurrent seizures. This case highlights SMART syndrome as a diagnosis of exclusion, notable for its shortened latency in comparison to the reported mean and rare association with meningioma, emphasizing the need for heightened clinical suspicion in patients with prior cerebral irradiation presenting with progressive neurologic deficits.

PMID 42688113
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PubMedThe Journal of pharmacy technology : jPT : official publication of the Association of Pharmacy Technicians2026-09-02

Assessment of Potential Drug Interactions in Patients With Chronic Kidney Disease Undergoing Hemodialysis.

da Silva Marcelino Maria Letícia ML, Balthazar Maria Eduarda ME, Zomer Dal Molin Christine C, Traebert Eliane E et al.

Background: Patients with chronic kidney disease (CKD) undergoing hemodialysis commonly present multiple comorbidities and require complex medication regimens. Polypharmacy increases the risk of clinically relevant drug interactions that may compromise treatment safety and effectiveness. Objective: To estimate the prevalence of potential drug interactions among patients with CKD undergoing hemodialysis and classify these interactions according to clinical risk and mechanism of action. Methods: A cross-sectional study was conducted with patients undergoing hemodialysis at a dialysis clinic in Southern Santa Catarina, Brazil. Potential drug interactions were identified using the Medscape and Drugs.com databases and classified according to severity (major, moderate, or minor) and mechanism of action. Results: A total of 151 patients were included. Potential drug interactions were identified in all participants (973 interactions; mean 6.4 per patient). Of these, 234 (24.0%) were classified as major, 545 (56.0%) as moderate, and 194 (19.9%) as minor. The most frequent major interactions involved furosemide + losartan (n = 8) and acetylsalicylic acid + clopidogrel (n = 6). Among moderate interactions, the most common were sevelamer + calcium carbonate (n = 14) and losartan + amlodipine (n = 12). The most frequent minor interactions involved epoetin alfa + acetylsalicylic acid (n = 14) and epoetin alfa + calcium carbonate (n = 10). Pharmacodynamic interactions predominated, mainly involving additive effects of cardiovascular medications. Conclusions: Potential drug interactions were highly prevalent among patients undergoing hemodialysis, with moderate-severity interactions predominating. Routine screening for potential drug interactions may support safer prescribing, optimize pharmacotherapy, and strengthen multidisciplinary medication management in this high-risk population.

PMID 42682735
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PubMedRevista panamericana de salud publica = Pan American journal of public health2026-09-01

Strengthening access to antihypertensive medicines through HEARTS in the Americas: the Grenada experience.

Renaud-Thomas Kerry-Ann KA, Mark Larissa L, Isaac Camille C, Malcolm Taraleen T et al.

To describe how Grenada leveraged the HEARTS in the Americas standardized clinical pathway to strengthen procurement of a single-pill fixed-dose antihypertensive and align prescribing and procurement across public and private sectors. Grenada adopted a national hypertension clinical pathway specifying a single-pill fixed-dose combination of telmisartan/amlodipine with chlorthalidone as preferred therapy. Implementation strategies included integration of pathway medicines into the essential medicines list and procurement systems; engagement of clinical and procurement leadership; dissemination to private providers; and engagement with private pharmacies. A descriptive analysis was conducted using predefined indicators aligned with adoption, feasibility, acceptability, and public-private alignment using survey data, program documents, procurement records, and routine reports. Integration of the standardized regimen into procurement processes supported availability of telmisartan/amlodipine and chlorthalidone in public primary care facilities, although supply gaps persisted. Adoption of a single national pathway supported standardized prescribing, forecasting, and centralized procurement. Dissemination to private clinicians and pharmacies contributed to uptake in the private sector, with pharmacies independently procuring pathway medicines, supporting continuity of care across sectors, although alignment remained incomplete. Facilitators included early stakeholder engagement, alignment between clinical and procurement leadership, and regimen simplification. Limitations included data system gaps and supply chain constraints. A standardized clinical pathway can strengthen procurement and promote public-private alignment in hypertension care. Addressing supply chain constraints remains essential for sustained access and continuity of treatment, with lessons applicable to other small island developing states implementing HEARTS.

PMID 42676909
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