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clomipramine hydrochloride + sildenafil citrate (Gusejeong / DKB22002 / DKB 22002)

✓ Approved

DongKoo Bio & Pharma · PDE5A · Small Molecule

What is clomipramine hydrochloride + sildenafil citrate?

clomipramine hydrochloride + sildenafil citrate is a small molecule developed by DongKoo Bio & Pharma. It is approved for therapeutic indications via oral (po).

Drug Profile

Brand NamesGusejeong, DKB22002, DKB 22002
CompanyDongKoo Bio & Pharma
Drug ClassSmall Molecule
Molecular TargetPDE5A
RouteOral (PO)
StatusApproved
Sources: ClinicalTrials.gov, DongKoo Bio & Pharma

Mechanism of Action

Molecular Targets

clomipramine hydrochloride + sildenafil citrate acts on 1 molecular target:

PDE5Aphosphodiesterase 5A (PDE5, CGB-PDE)
Want deeper analysis?Noah AI can explain complex mechanisms and compare to similar drugs.

Therapeutic Indications

clomipramine hydrochloride + sildenafil citrate is developed for 2 unique indications across 2 therapeutic areas.

Therapeutic AreaConditionPhase
Psychiatric disordersPremature ejaculation✓ Approved
Reproductive system and breast disordersErectile dysfunction✓ Approved

Related Research Articles

PubMedLaboratory medicine2026-09-20

Effect of sodium citrate and magnesium sulphate anticoagulation on platelet parameters measured on the Alinity hq analyzer.

Betzer Cristine C, McGrail Rie R

EDTA-dependent pseudothrombocytopenia (PTP) may cause spuriously low platelet counts and can be prevented by using alternative anticoagulants, such as sodium citrate (citrate) and magnesium sulphate (MgSO4). However, these anticoagulants may affect platelet parameters depending on the analytical platform. Their effect on platelet measurements using the Abbott Alinity hq hematology analyzer has not previously been evaluated. Blood samples from 40 outpatients without known PTP were collected in K2-EDTA, citrate, and MgSO4 tubes. Platelet count, mean platelet volume, and reticulated platelet fraction were measured on an Alinity hq analyzer. Paired comparisons were performed using Friedman repeated-measures analysis with the Dunn multiple comparisons test. Compared with EDTA, median platelet counts were statistically significantly lower in citrate (-21.1%) and MgSO4 (-31.7%) than in EDTA (P < .05). Mean platelet volume was also statistically significantly reduced in citrate (-3.2%) and MgSO4 (-4.7%) (P < .05). Median reticulated platelet fraction was slightly higher in both anticoagulants, but only MgSO4 differed substantially from EDTA. On the Alinity hq analyzer, citrate and MgSO4 result in statistically significantly lower platelet count than EDTA in samples from individuals without known PTP. Platelet parameters are therefore influenced by anticoagulant choice and should not be interpreted interchangeably.

PMID 42763434
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PubMedLipids in health and disease2026-09-20

Real-world use of bempedoic acid for hypercholesterolaemia: a German multicentre, retrospective, cohort study.

Haberbosch Linus L, Baessler Andrea A, de Ruiter Ulrike U, Sinning David D et al.

Dyslipidaemia remains a leading cause of death in Germany despite an improving therapeutic landscape, with many patients not achieving guideline-recommended low-density lipoprotein cholesterol (LDL-C) goals. Bempedoic acid, an adenosine triphosphate citrate lyase inhibitor, is a recent addition to the therapeutic landscape with proven efficacy in randomised controlled trials; however, its use varies between centres. We aimed to assess the short-term, real-world effectiveness of bempedoic acid in lowering LDL-C levels in patients in Germany. This retrospective, observational study was conducted using data from patients with primary hypercholesterolaemia or mixed dyslipidaemia, collected before and approximately 3 months after initiating bempedoic acid in 7 specialised lipid outpatient clinics in Germany. Data were analysed from a total of 641 patients, with a mean age (standard deviation [SD]) of 63.2 (11.3) years. The addition of bempedoic acid significantly reduced LDL-C levels from a mean of 133.6 mg/dL at baseline to 101.8 mg/dL after 3 months (p < 0.001). The mean within-patient LDL-C reduction was 31.8 mg/dL and the mean patient-level percentage change was -17.5%. Mean patient-level changes were -4.9% for HDL-C and -12.0% for total cholesterol; triglycerides did not change significantly. At 3 months, patients not receiving any lipid-lowering therapy (LLT) other than bempedoic acid had a mean patient-level LDL-C reduction of 27.1%; corresponding mean reductions were 23.7% with ezetimibe, 20.3% with PCSK9 inhibitor therapy, 9.0% with statin therapy and 6.1% with statin plus ezetimibe. Suspected adverse events were documented in 218/641 patients (34.0%), and 171/641 (26.7%) had discontinued bempedoic acid by follow-up. Myalgia was the most commonly reported adverse event in patients discontinuing treatment (75 cases). Findings from this real-world, multicentre study conducted in Germany show that bempedoic acid may present an effective treatment option for patients with hypercholesterolaemia who are already receiving LLT, in addition to being an effective option for patients not receiving/tolerating other LLTs. The magnitude of LDL-C reduction differed across background treatment strategies, while suspected adverse events and treatment discontinuation were common in this specialist-care cohort.

PMID 42763399
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PubMedBritish journal of clinical pharmacology2026-09-19

CYP3A5 genetic variability influences sildenafil and metabolite in pulmonary hypertension.

Wongwien Pranisa P, Pussadhamma Burabha B, Kanjanawart Sirimas S, Areesinpitak Thikhumporn T et al.

Interindividual variability in sildenafil response among pulmonary hypertension patients (PH) may be influenced by CYP3A5 polymorphisms. CYP3A5*3 allele reduces CYP3A5 activity and affects sildenafil metabolism. This study investigated the associations between CYP3A5 genotype and plasma concentrations of sildenafil and N-desmethyl sildenafil, as well as clinical outcomes, in PH. A cross-sectional study of 92 patients with PH was conducted. Blood samples were collected at trough and 1 h after sildenafil administration (C1h). Plasma concentrations were quantified by HPLC, and CYP3A5 genotypes were determined by real-time PCR with TaqMan probes. Thirteen (14.13%) patients carried the CYP3A5 *1/*1 genotype, and 79 (85.87%) carried the CYP3A5*3 allele. CYP3A5*3 allele carriers had a significantly higher mean C1h sildenafil concentration-to-dose (C/D) ratio than CYP3A5*1/*1 carriers (3.61 ± 2.69 vs. 2.66 ± 1.20 ng/mL/mg; p = 0.043). The mean C1h of sildenafil, trough sildenafil concentration and trough sildenafil C/D ratio were higher in CYP3A5*3 carriers, but not statistically significant. The trough and C1h of N-desmethyl sildenafil and their corresponding C/D ratios were lower in CYP3A5*3 carriers but did not reach statistical significance. CYP3A5*3 allele carriers showed greater improvement in 6-min walk distance (33.74 ± 43.46 m vs. -5.58 ± 44.52 m; p = 0.005), WHO functional class (32.00% vs. 15.39%; p = 0.042) and EmPHasis-10 scores (-4.15 ± 6.46 vs. 1.08 ± 3.80; p = 0.009). The CYP3A5*3 allele is associated with higher sildenafil exposure and superior clinical outcomes. Therefore, CYP3A5 genotyping may facilitate personalized assessment of sildenafil efficacy and clinical outcomes.

PMID 42760608
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PubMedTheScientificWorldJournal2026-09-19

Evaluating Safety and Efficacy of Bio-Immune (Andrographolide) in Managing URTI Symptoms: A Randomized, Double-Blinded, Placebo-Controlled, Single-Center, Comparative Study.

Singh Shashi Chandrama SC, Choudhary Muskan M, Choudhary Khushi K, Singh Harsh Pal HP

Bio-Immune is a standardized extract containing andrographolide, a diterpenoid lactone derived from the aerial parts of Andrographis paniculata (commonly known as Kalmegh), and the carrier, 2-hydroxypropyl beta-cyclodextrin. Kalmegh has long been used to treat uncomplicated upper respiratory tract infection (URTI) in complementary and alternative medicine. A randomized, double-blind, placebo-controlled clinical trial was conducted to evaluate the efficacy of Bio-Immune (≥ 17% w/w andrographolide content). Participants were randomized to receive either 100 mg Bio-Immune twice daily or placebo for a 5-day intervention period (Clinical trial registration number: CTRI/2024/12/077632, Registered 4, December 2024). The primary outcome measure was the Wisconsin Upper Respiratory Symptom Survey-21 (WURSS-21) score; secondary outcomes included Visual Analogue Scale (VAS) and Numeric Rating Scale (NRS) scores, nasal mucus weight, C-reactive protein (CRP), Interleukin-8 (IL-8), and Immunoglobulin A (IgA) in nasal wash, along with safety. Of 67 screened participants, 56 were enrolled, and 55 completed the study. The WURSS-21, VAS, and NRS scores in the Bio-Immune group improved, with statistically significant reductions suggesting relief from symptoms associated with uncomplicated URTI and sustained functional improvement owing to Bio-Immune supplementation. Although the placebo group showed gradual improvement over time, the speed and magnitude of recovery were consistently and statistically superior in the Bio-Immune cohort, with significant changes evident by 6 h after supplementation. Furthermore, a significant reduction in nasal mucus weight was observed by Day 5, accompanied by minor downward trends in CRP and IL-8, which lacked adequate statistical support. No adverse events were reported during the intervention period. Clinical findings support the efficacy of Bio-Immune at a lower dose in providing URTI symptom relief compared with placebo in a shorter intervention period. Clinical Trial Registry of India: CTRI/2024/12/077632; ClinicalTrials.gov identifier: NCT06689995.

PMID 42760788
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PubMedFrontiers in plant science2026-09-19

Editorial: Mitigating agricultural greenhouse gas emissions through bio-inputs and innovative practices.

Uarrota Virgilio Gavicho VG, Maraschin Marcelo M, Foereid Bente B

PMID 42761808
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PubMedInternational journal of gynaecology and obstetrics: the official organ of the International Federation of Gynaecology and Obstetrics2026-09-19

A decade of decline and regional disparity: Trends and associated factors in use of ritodrine hydrochloride for threatened preterm labor in Japan, a nationwide ecological study.

Yorozu Kazuma K, Hinotsu Shiro S, Matsuura Motoki M, Someya Masayuki M et al.

Ritodrine hydrochloride is a commonly used tocolytic agent for threatened preterm labor in Japan, despite its serious adverse events and limited use in many other countries. National obstetric guidelines have shifted toward restricting its use, but the evidence-practice gap remains unclear. The aim of this study is to determine usage trends for ritodrine at nationwide and prefectural levels and identify factors associated with usage. We conducted an ecological study linking nationwide aggregated medical claims data and statistical survey records across all 47 prefectures. We investigated 10-year trends in ritodrine use from fiscal year (FY) 2014 to 2023. Choropleth maps and spatial statistics illustrated geographic relationships among neighboring prefectures. We also conducted a cross-sectional study to identify factors associated with ritodrine injection use. The usage rate of ritodrine injection per 1000 deliveries decreased by more than 45% over 10 years. Joinpoint regression analysis identified FY2017 as a turning point, after which the decline accelerated. However, prefectural usage varied up to 13.58-fold, with spatial clustering of high-use regions. Factors associated with injection usage included the density of Perinatal Medical Centers (PMCs), hospital admissions for threatened preterm labor and preterm birth per 1000 deliveries, and the proportion of hospitals among delivery facilities. This study showed that nationwide use of ritodrine injection decreased by half over a decade, along with regional disparities among prefectures in Japan. These variations might reflect localized treatment policies influenced by differences in healthcare resources and geographical accessibility.

PMID 42760829
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