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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

PubMedNeuromolecular medicine2026-08-30

AMBMP Hydrochloride Reverses STZ-Induced Alzheimer-Type Dementia Associated with Wnt/β-catenin/TLR4 Signaling.

Kalra Palak P, Chaturvedi Deepak D, Kumar Amit A, Grewal Amarjot Kaur AK et al.

Alzheimer's disease (AD) is a debilitating neurodegenerative disorder with progressive cognitive decline and neuronal loss. This study investigated the neuroprotective effects of AMBMP Hydrochloride, a Wnt/β-catenin agonist, in a streptozotocin (STZ)-induced mice model of AD, elucidating the interplay between dysregulated Wnt/β-catenin signaling and Toll-Like Receptor 4 (TLR4)-mediated inflammation, with Palmitic acid used as a TLR4 pathway modulator. Mice received bilateral intracerebroventricular (i.c.v.) injections of STZ (3 mg/kg) on Day 1 and Day 3, followed by administration of Donepezil (3 mg/kg)/ AMBMP Hydrochloride (5 mg/kg and 10 mg/kg)/Palmitic acid (TLR4 agonist, 20 mg/kg) via the intraperitoneal (i.p.) route from Day 4 to Day 22. STZ-treated mice exhibited significant cognitive dysfunction, characterized by impaired performance in the Morris Water Maze (MWM) task along with increase in acetylcholinesterase (AChE) activity, oxidative stress (thiobarbituric acid reactive substances; TBARS), neuroinflammation [tumor necrosis factor alpha (TNF-α)/Interleukin-6 (IL-6)/Interleukin-1 beta (IL-1β) and nuclear factor kappa B (NF-κB)] and decreased reduced glutathione (GSH) levels. However, AMBMP Hydrochloride significantly improved behavioral and biochemical alterations possibly through modulation of Wnt/β-catenin signaling and attenuation of TLR4-mediated inflammation. Interestingly, Palmitic acid co-treatment was found to counteract these protective effects, further pointing to a role of TLR4 in the pharmacological effect of AMBMP Hydrochloride. In summary, we confirmed that AMBMP Hydrochloride exhibits potent neuroprotective effects associated with modulating Wnt/β-catenin/TLR4 signaling, offering a promising therapeutic approach against Alzheimer-Type Dementia. Future studies should delve deeper into the molecular mechanisms and translational promise of AMBMP hydrochloride, paving the way for its development as a potential candidate for AD management.

PMID 42668333
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PubMedEuropean heart journal2026-08-30

Adrenomedullin system dysregulation predicts cardiogenic shock and mortality in acute coronary syndromes.

Wang Yifan Y, Danchin Nicolas N, Simon Tabassome T, Zeller Marianne M et al.

Cardiogenic shock (CS) is the most dreadful complication of acute coronary syndromes (ACS). Endothelial dysfunction and vascular leakage are hallmarks of CS pathophysiology; however, biomarkers reflecting these early processes are lacking. The adrenomedullin (ADM) system-the inactive precursor glycine-extended ADM (ADM-Gly), the activating enzyme peptidylglycine α-amidating monooxygenase (PAM), and biologically active ADM (bio-ADM)-modulates vascular tone and permeability. This study investigated associations of ADM system components with CS and 1-year mortality risk after ACS. ADM-Gly, PAM, and bio-ADM were assessed in 4098 (Switzerland; SPUM-ACS) and 824 (France; FAST-MI) ACS patients without CS on admission. The primary endpoint was in-hospital CS; the secondary endpoint was 1-year mortality. Biomarker-outcome associations were analysed using multivariable-adjusted regression models, and the incremental predictive value beyond established risk scores was quantified. Higher ADM-Gly and bio-ADM, but not PAM, were associated with systemic inflammation and haemodynamic compromise. ADM-Gly and bio-ADM independently predicted CS risk in Switzerland (adjusted odds ratio [aOR] per log2 increase, 1.44, 95% confidence interval [CI] 1.22-1.71, P < .001 and aOR 1.37, 95% CI 1.10-1.70, P = .004) and France (adjusted risk ratio [RR] per log2 increase, 1.82, 95% CI 1.34-2.48, P < .001 and aRR 1.55, 95% CI 1.15-2.10, P = .004), and were associated with 1-year mortality risk (adjusted hazard ratio [aHR] per log2 increase, 1.33, 95% CI 1.09-1.61, P = .005 and aHR 1.46, 95% CI 1.15-1.86, P = .002). Addition of ADM-Gly and bio-ADM to the ORBI risk score improved its discrimination (Δ area under the receiver operating characteristic curve 0.02), reclassification (net reclassification improvement 0.229), and model fit (Δ Akaike information criterion -26.9), with consistent results in external validation. ADM-Gly and bio-ADM, but not PAM, independently predict in-hospital CS and 1-year mortality risk in initially stable patients with ACS and improve early risk stratification.

PMID 42668424
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PubMedAdvanced science (Weinheim, Baden-Wurttemberg, Germany)2026-08-30

Regulating Cells Fate and Function to Facilitate Bone Regeneration via Designing Programmable Bio-Interactive Materials.

Fan Qingrui Q, Cao Fuming F, Mao Junqiang J, Yin Pengbin P et al.

Achieving efficient bone repair necessitates a thorough understanding of the physiological activities of native bone tissue, enabling selection and design of appropriate materials. To date, artificial scaffolds have been developed from inert materials to bioactive materials and demonstrate the capabilities to promote bone repair. However, the complex physiological changes that occur during bone repair pose significant challenges to their practical clinical applications. In this Review, we summarize the studies of bone biology and the evolution of materials design in the context of bone-tissue engineering applications. Specifically, we emphasize the role of biomaterials from a materials science perspective in regulating cell fates. Furthermore, we introduce the concept of programmable bio-interactive materials as a potential solution for bone regeneration. These materials possess the ability to dynamically and precisely interact with biological systems, guiding the bone-tissue regeneration process. Additionally, we discuss the unmet needs and current challenges faced in the development of bio-interactive materials for bone-tissue regeneration. By highlighting emerging strategies in the field, we aim to shed light on future directions for research and development in this exciting area of study.

PMID 42669154
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PubMedFood chemistry: X2026-08-30

Effect of solid-state fermentation on the release and antioxidant activity of soluble polyphenols from wheat bran.

Tian Xiaomin X, Guo Yuqiu Y, Sun Linlin L, Chen Lirong L et al.

Using wheat bran as substrate, four solid-state fermentation methods were compared for soluble polyphenol release. The effect of Bio-enzymatic synergy (BES) is the most significant, producing 4.85 mg GAE/g of total phenolic substances, which is 45.77% higher than the control group (CK). LC-MS analysis revealed that ferulamide and 2,4,6-trihydroxybenzoic acid predominated in positive ion mode, while salicylic acid dominated in negative mode. Notably, salicylic acid was found almost exclusively in ester-bound and glycoside-bound fractions (>88%), indicating its release requires cleavage of covalent linkages to cell wall components. The release of salicylic acid results from the synergistic action of Bio-enzymatic synergy and alkaline hydrolysis. Both in vitro and in vivo assays confirmed that BES-released polyphenols enhanced antioxidant activity, reducing ROS and MDA levels while increasing GSH-Px activity and extending C. elegans lifespan. These findings provide a mechanistic basis for developing targeted fermentation-enzymatic processes to produce functional wheat bran extracts.

PMID 42668496
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PubMedPakistan journal of medical sciences2026-08-30

Efficacy of Bromhexine hydrochloride combined with bronchoalveolar lavage under fiberoptic bronchoscopy in the treatment of mild to moderate community-acquired pneumonia.

Hu Feiyan F, Lin Li L, Lv Feijing F, Xu Yanan Y et al.

To evaluate the clinical efficacy of bromhexine hydrochloride (BRH) combined with fiberoptic bronchoalveolar lavage (BAL) under fiberoptic bronchoscopy (FOB) in the treatment of patients with community-acquired pneumonia (CAP). This retrospective cohort study included clinical data from 126 patients with mild-to-moderate CAP treated at Yongkang First People's Hospital from March 2023 to March 2025. Of them, patients treated with BRH alone (BRH group, n=63) were matched 1:1 to a cohort treated with BRH combined with fiberoptic bronchoscopic BAL under FOB (BRH & BAL group, n=63). The primary outcome was clinical efficacy. Secondary outcomes included clinical symptoms, levels of inflammatory factors, and incidence of adverse reactions. After treatment, the efficacy of the BRH & BAL group (95.2%) was significantly higher than that of the BRH group (84.1%) (P<0.05). Post-treatment duration of fever, time to cough relief, time to resolution of pulmonary rales, and hospital length of stay in the BRH & BAL group were all shorter than those in the BRH group (P<0.05). After treatment, the levels of IL-6, CRP, and PCT in both groups were considerably lower than pre-treatment and significantly lower in the BRH & BAL group than in the BRH group (P<0.05). There was no statistically significant difference in the incidence of adverse reactions between the two groups (P>0.05). BRH combined with BAL under FOB for the treatment of mild-to-moderate CAP is associated with improved therapeutic efficacy, alleviation of clinical symptoms, reduction of the inflammatory response, and good safety.

PMID 42668875
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PubMedInternational journal of pharmaceutics: X2026-08-30

Water-triggered in-situ gelling phospholipid oil enema for enhanced budesonide delivery and mucosal healing in ulcerative colitis.

Ouyang Ting T, Chen Yumo Y, Jia Yiying Y, Li Jiarui J et al.

Budesonide (BUD) enema therapy for ulcerative colitis (UC) is limited by poor solubility, inadequate bio-adhesion, and rapid clearance due to intestinal peristalsis. To address the limitations of conventional budesonide enemas, we designed a water-triggered in situ phase-transition phospholipid formulation (termed PG oil). This system comprises soybean phosphatidylcholine (PC-98), glyceryl dioleate (GDO), propylene glycol, and anhydrous ethanol, and achieves markedly enhanced BUD solubilization (35 mg/mL), in contrast to its negligible aqueous solubility (0.021 mg/mL). Upon contact with colonic fluid, PG oil rapidly underwent sol-gel transition, forming a bio-adhesive lamellar liquid crystalline gel that serves as both a physical mucosal barrier and a sustained-release drug depot. In a dextran sulfate sodium (DSS)-induced colitis mouse model, rectal administration of BUD-PG oil (0.3 mg/kg) significantly outperformed free BUD suspension, as evidenced by restored body weight, reduced disease activity index, normalized colon length, and decreased spleen index. Immunohistochemistry revealed marked suppression of pro-inflammatory cytokines (IL-6, TNF-α, IL-1β, MCP-1) in colonic tissue. Histological analysis demonstrated that BUD-PG promoted favorable mucosal repair characterized by reduced collagen deposition (Masson's trichrome: from 48.5% to 16.7%) while restoring gut barrier integrity through replenishment of goblet cells and upregulation of tight junction proteins (ZO-1, Occludin-1, Claudin-5, β-catenin). Collectively, this water-responsive in situ gelling phospholipid oil platform addresses critical limitations of conventional BUD enemas by combining sustained local drug delivery with physical mucosal protection, offering a promising therapeutic strategy for comprehensive mucosal healing in UC.

PMID 42668512
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