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Last update 26 May 2025

Tamsulosin Hydrochloride

Last update 26 May 2025

Overview

R&D Status

Clinical Result

Translational Medicine

Overview

Basic Info

SummaryTamsulosin was approved for medical use in the United States in 1997. Specifically it is an α1 adrenergic receptor blocker. Tamsulosin, sold under the brand name Flomax among others, is a medication used to treat symptomatic benign prostatic hyperplasia (BPH) and chronic prostatitis and to help with the passage of kidney stones. The evidence for benefit with a kidney stone is better when the stone is larger. It is taken by mouth. Common side effects include dizziness, headache, sleeplessness, nausea, blurry vision, and sexual problems. Other side effects may include feeling lightheaded with standing and angioedema. Tamsulosin is an alpha blocker and works by relaxing muscles in the prostate.

Drug Type

Small molecule drug

Synonyms

(-)-tamsulosin, (R)-(-)-tamsulosin, (R)-5-(2-((2-(2-ethoxyphenoxy)ethyl)amino)propyl)-2-methoxybenzenesulfonamide

+ [36]

Target

α1A-AR

Action

antagonists

Mechanism

α1A-AR antagonists(Alpha-1a adrenergic receptor antagonists)

Therapeutic Areas

Urogenital DiseasesOther Diseases

Active Indication

Lower Urinary Tract SymptomsProstatic Hyperplasia

Inactive Indication

Acute retention of urineDysuriaErectile Dysfunction+ [6]

Originator Organization

Astellas Pharma, Inc.

Active Organization

Astellas Pharma Europe BVAstellas Pharma Australia Pty Ltd.Yamanouchi Pharmaceutical Co., Ltd.

+ [2]

Inactive Organization

Boehringer Ingelheim GmbHAstellas Pharma Europe Ltd.

Sanofi-Aventis U.S. LLC

+ [1]

License Organization

Qingdao Baheal Medical, Inc.

Astellas Pharma, Inc.

Drug Highest PhaseApproved

First Approval Date

Japan (02 Jul 1993),

Prostatic Hyperplasia

RegulationPriority Review (China)

Structure/Sequence

Molecular FormulaC20H29ClN2O5S

InChIKeyZZIZZTHXZRDOFM-XFULWGLBSA-N

CAS Registry106463-17-6

319

Clinical Trials associated with Tamsulosin Hydrochloride

NCT06966804

/ Not yet recruitingPhase 3IIT

Efficacy of Alpha Blockers (Terazosin vs Tamsulosin) in Reducing Ureteral Stent Related Symptoms - An Open-label, Randomized Controlled Trial

The goal of this clinical trial is to compare how well Terazosin, Tamsulosin and standard care (no alpha-blocker) reduce urinary symptoms after ureteral stent placement. This trial also learn about the safety of these two study medications.
Main objective:
• To compare how well Terazosin, Tamsulosin and standard of care reduce post-stenting urinary symptoms.
Secondary objectives:
* To compare painkiller use among the groups.
* To assess differences in Body pain, General health, Work performance, Sexual matters, and Additional problems using a questionnaire (USSQ).
* To assess differences in side effects.
After stent placement, subjects will be randomly assigned to one of three groups:
1. Terazosin (alpha-blocker) for 14 days
2. Tamsulosin (alpha-blocker) for 14 days
3. Standard of care (no alpha-blocker). All subjects will be discharged with standard pain-killers and a diary to track usage. Subjects in Terazosin and Tamsulosin groups will receive respective study medications to complete 14 days course of treatment.
Follow-Up:
* Day 7: A phone call will check medication use and any side effects.
* Day 15: Clinic visit for stent removal (standard practice). Subjects will complete the USSQ questionnaire, and medication compliance will be reviewed.
End of study: Final phone call to check for any additional side effects.

Start Date01 Jun 2025

Sponsor / Collaborator

Penang Adventist Hospital

NCT06803030

/ Not yet recruitingPhase 3IIT

A Comparative Study on the Efficacy of Tamsulosin, Solifenacin and Mirabegron in Alleviating Ureteral Stent-related Symptoms: a Randomized Controlled Trial

A comparative study on the efficacy of Tamsulosin, Solifenacin and Mirabegron in alleviating ureteral stent-related symptoms: a randomized controlled trial.

Start Date01 Apr 2025

Sponsor / Collaborator

Bir Hospital

NCT06865430

/ RecruitingNot ApplicableIIT

Management of Dysuria and Irritative Symptoms After HoLEP: a Prospective Study Evaluating the Efficacy of Alpha-Blocker Therapy

Holmium Laser Enucleation of the Prostate (HoLEP) is an increasingly popular endoscopic minimally invasive surgical technique for the treatment of benign prostatic hyperplasia (BPH). In the literature, the long-term efficacy and low complication rates of HoLEP have been highlighted in many studies. However, in the early postoperative period, particularly within the first three months, irritative symptoms are reported in 17-35% of cases (1-2).
The pathophysiology of postoperative irritative symptoms is not yet fully understood, but it has been suggested that these symptoms may be associated with urethral trauma, the mucosal healing process, and detrusor overactivity. These symptoms can significantly impact quality of life, reducing patient satisfaction. In particular, dysuria is a frequently encountered symptom after HoLEP, with considerable individual variability in its severity and duration.
The effectiveness of alpha-blockers in alleviating postoperative dysuria and irritative symptoms remains a topic of debate in the literature. Although prostate tissue is surgically removed, alpha-blockers may improve urinary flow and relieve symptoms associated with bladder outlet obstruction by reducing urethral smooth muscle tone (3). Studies on the use of alpha-blockers following transurethral resection of the prostate (TURP) have shown limited postoperative benefits (4). However, to the best of our knowledge, no study has specifically evaluated their use following HoLEP, an enucleation-based technique. Therefore, further studies are needed to assess the role of alpha-blockers in managing dysuria after HoLEP.
The aim of this study is to evaluate the effectiveness of alpha-blocker therapy in managing dysuria and other irritative symptoms following HoLEP. Additionally, the study seeks to determine the impact of this treatment on quality of life and patient satisfaction.

Start Date04 Mar 2025

Sponsor / Collaborator-

100 Clinical Results associated with Tamsulosin Hydrochloride

100 Translational Medicine associated with Tamsulosin Hydrochloride

100 Patents (Medical) associated with Tamsulosin Hydrochloride

3,215

Literatures (Medical) associated with Tamsulosin Hydrochloride

01 Jul 2025·AMERICAN JOURNAL OF OPHTHALMOLOGY

Drugs Associated With Floppy Iris Syndrome: A Real-World Population-Based Study

Article

Author: Kwan, Angela T H ; Popovic, Marko M ; Mihalache, Andrew ; Lakhani, Moiz ; Hurley, Bernard ; Muni, Rajeev H

PURPOSE:

Intraoperative floppy iris syndrome (IFIS) is associated with an increased rate of severe intraoperative complications and greater visual morbidity during cataract surgery, particularly in females. To date, no postmarketing pharmacovigilance study has comprehensively examined all FDA-approved drugs for their association with IFIS development or explored potential sex differences. Understanding the risk factors for IFIS allows cataract surgeons to better stratify surgical risks and implement appropriate preoperative and intraoperative measures to ensure adequate management in high-risk patients.

DESIGN:

Retrospective pharmacovigilance clinical cohort study.

METHODS:

This population-based, observational study analyzed IFIS cases reported to the Food and Drug Administration Adverse Event Reporting System from October 2003 to March 2024 using OpenVigil 2.1. Disproportionality metrics, including reporting odds ratios (RORs), proportional reporting ratios (PRRs), and relative risk reductions, were used to assess signals for positive adverse reactions (n > 2, χ² > 4, PRR > 2), compared to all other drugs. Subgroup analyses were also conducted by sex.

RESULTS:

Of 12,345,128 adverse event reports, 649 (0.0053%) involved IFIS. The majority of cases were reported by healthcare professionals (75.75%, n = 203), followed by consumers (12.69%, n = 34) and unknown sources (11.57%, n = 31). Drugs with the highest disproportionality for IFIS included imipramine (ROR = 251.66, 95% confidence interval [CI] = 157.53-402.02), tamsulosin (ROR = 171.44, 95% CI = 143.12-205.36), and chlorpromazine (ROR = 91.30, 95% CI = 49.91-167.03) (all P < .0001, IC₀₂₅ > 0). Over-reported drug classes included α1-blockers, tricyclic antidepressants, atypical antipsychotics, carbonic anhydrase inhibitors, corticosteroids, 5α-reductase inhibitors, β-blockers, prostaglandin analogs, and β2-agonists. Among females, brinzolamide (ROR = 409.63, 95% CI = 196.78-852.73) and salbutamol (ROR = 67.12, 95% CI = 28.37-158.80) were disproportionately associated with IFIS (both P < .0001, IC₀₂₅ > 0), whereas these associations were not observed in males.

CONCLUSIONS:

This analysis of over 20,000 drugs and 12 million reports highlights that, in addition to α1-blockers and atypical antipsychotics, tricyclic antidepressants are among the key agents most disproportionately associated with IFIS, with notable sex differences. These findings are crucial for informing perioperative counseling and surgical planning for cataract surgery.

01 Jun 2025·JOURNAL OF MOLECULAR LIQUIDS

Volumetric and sonometric properties of ionic aminated resorcin[4]arenes in water and DMSO at 278.15 K to 303.15 K

Author: Vargas, Edgar F. ; Espitia-Galindo, Nicolas ; Hefter, Glenn

Understanding supramol. chem. requires comprehensive knowledge of macrocycle behavior in solutionThis study reports standard molar volumes and compressibilities of the chloride salts of two cationic macrocycles C-methylresorcin[4]arene-tetraminoethylated-hydrochloride (TAE·(HCl)₄) and their C-Et analog (ETAM·(HCl)₄) in aqueous and DMSO solutionsThese quantities were obtained using d. and speed of sound measurements at concentrations (0.005 to 0.08) mol·kg^-1 and temperatures in the range (278.15 to 308.15) K.NMR techniques were used to study the structures of the macrocycles in solution, while the corresponding compounds were characterised using mass spectrometry, thermogravimetry and differential scanning calorimetry.The partial molar quantities derived from the volumetric and sonometric data are discussed, along with relevant literature information, in terms of solute-solvent interactions.Structural modifications of macrocycles influence the standard molar compressibilities through changes in solvent organization around functional groups, intrinsic compressibility, and water mols. in the resorcinarene cavity.The effect of carbon chain length on the volumes and compressibilities of substituted resorcin[4]arenes is shown to depend on their location in the macrocycle, but not on the solvent.The standard molar volume is shown to be influenced by ionic moieties and intramol. hydrogen bonds.

01 Jun 2025·AMERICAN JOURNAL OF OPHTHALMOLOGY

Unplanned Return to the Operating Room After Cataract Surgery

Article

Author: Suazo, Mallory K ; Akhlaq, Anam ; Khan, Malik Muhammad Hamza ; Schein, Oliver D ; Ali, Muhammad ; Woreta, Fasika A

PURPOSE:

To determine the rate of unplanned return to the operating room (OR) within 90 days of cataract surgery and to identify the most common preoperative and intraoperative risk factors.

DESIGN:

Retrospective case-control study.

SUBJECTS AND CONTROLS:

Patients aged ≥40 years undergoing cataract surgery at the Wilmer Eye Institute between 2019 and 2022 with at least 90 days of postoperative follow-up were included. Patients with return to the OR for a reason other than a postoperative complication of cataract surgery in the same eye were excluded. For each case, a time-matched control (cataract surgery within 1 month of the case's surgery) was selected using a random number generator.

METHODS:

The chi-squared test was used for categorical variables, the student's t-test for continuous variables, and the multivariable logistic regression analysis to assess for associated preoperative and intraoperative factors.

MAIN OUTCOME MEASURES:

The main outcomes included the rate and the most common reasons for unplanned return to the OR as well as the odds ratios of associated preoperative and intraoperative variables.

RESULTS:

Among 32,480 eyes, 175 eyes (0.54%) had an unplanned return to the OR within 21 ± 21 days of cataract surgery. The most common reason was retained lens fragments in 88 eyes (50%). Patients with an unplanned return to the OR had a worse mean best-corrected visual acuity preoperatively (Snellen equivalent of ∼20/100 for cases vs 20/50 for controls, p-value < .001) and at last follow-up (cases 20/50, controls 20/30, p-value < .001). There were significantly higher odds of an unplanned return to the OR for patients undergoing complex cataract surgery (odds ratio, 1.80; 95% CI, 1.06-3.05) and for patients with prior tamsulosin use (odds ratio, 2.00; 95% CI, 1.09-3.69).

CONCLUSIONS:

Patients undergoing complex cataract surgery and those with prior tamsulosin use had significantly higher odds of unplanned return to the OR. Monitoring rates of unplanned return to the OR at the institutional and national levels by using national clinical registries or a multicenter study is needed to assist in quality monitoring and to improve patient surgical outcomes.

News (Medical) associated with Tamsulosin Hydrochloride

15 May 2025

·www.globenewswire.com

Teleflex Showcases New Clinical Data Presented at the 2025 American Urological Association (AUA) Annual Meeting

Two Head-to-Head Randomized Trials Highlight Superior Early Patient Experience with the UroLift™ System for BPH1-2 First-Ever Analysis Utilizing the American Urological Association Quality Registry (AQUA) to Assess BPH Treatment Modalities Shows Strongest Symptom Improvement Score Shift with UroLift™ System at Three Months.3 First Study to Confirm Safety of Stabilized Hyaluronic Acid (sHA) Rectal Spacer in Cases with Rectal Wall Infiltration (RWI).4 WAYNE, Pa., May 15, 2025 (GLOBE NEWSWIRE) -- Teleflex Incorporated (NYSE: TFX), a global leader in medical technologies, today announced the presentation of compelling new clinical data at the 2025 American Urological Association (AUA) Annual Meeting in Las Vegas, held April 26–29. Data from two randomized controlled trials (RCTs) reinforce the UroLift™ System’s advantages compared with Rezūm and tamsulosin, particularly in terms of early patient satisfaction, rapid symptom relief, and sexual function outcomes.1-2 The UroLift™ System, also referred to as Prostatic Urethral Lift (PUL), is the chosen leader in minimally invasive procedures for benign prostatic hyperplasia (BPH) in the U.S.5 “These studies underscore our commitment to evidence-based innovation. The UroLift™ System continues to stand out as a patient-centered therapy offering meaningful improvements in symptoms and quality of life,” said Claus Roehrborn, MD,* professor of urology at UT Southwestern Medical Center and primary investigator on the studies. “With more than 14 years of BPH research behind us, including ongoing head-to-head comparisons, we’re giving clinicians and patients the critical data to support evidence-based shared decisions.”The following research presentations outlined the key findings from the studies: Results from the CLEAR RCT Suggest Factors Corresponding to Early Patient Satisfaction Are Better Following UroLift PUL vs. Rezum WVTT1† Men treated with the UroLift™ System were significantly more satisfied with their results at two weeks and at one month after treatment.1Those who received the UroLift™ System procedure also had shorter catheterization times, better symptom relief, and better sexual function outcomes during the early recovery period compared to Rezūm™ patients.1 UroLift™ PUL Demonstrates Significantly Better Efficacy and Patient Experience Outcomes vs. Tamsulosin: Results from the IMPACT RCT2† At three months, men who were treated with the UroLift™ System showed significantly better symptom improvement compared to those who took medication.2UroLift™ System patients reported better sexual function outcomes and overall experience.‡ In fact, 70% of men randomized to the medication treatment arm eventually chose to crossover to the UroLift™ System.2 Using the American Urological Association Quality Registry (AQUA) BPH Dataset to Assess Early Symptom Improvement after Treatment3 Real-world data from the AQUA BPH database corroborate evidence that BPH drugs provide modest or no improvement and that PUL provides rapid symptom score improvement at three months.3 Safety of Stabilized Hyaluronic Acid (sHA) as a Rectal Spacer: Low Risk of Rectal Wall Infiltration and Reversibility4 This study presents the first evidence for the safety of sHA rectal spacer in cases of RWI, demonstrating sHA spacers are safe, effective, and allow for individualized spacing with low risk of severe complications, such as ulcers or fistulas.4 “These findings reaffirm the safety profile of stabilized hyaluronic acid as a rectal spacer and highlight its reversibility as a distinct clinical advantage,” said Michelle Svatos, director of Barrigel™ rectal spacer product development and research. “With a low incidence of rectal wall infiltration and no severe complications observed, this study strengthens our confidence in sHA as a safe and customizable option for protecting patients during prostate cancer treatment." For more information about the UroLift System, visit www.UroLift.com, and for more information about Barrigel Rectal Spacer, visit www.Barrigel.com. About the UroLift™ SystemThe UroLift™ System is a minimally invasive treatment for lower urinary tract symptoms due to benign prostatic hyperplasia (BPH). It is indicated for the treatment of symptoms of an enlarged prostate up to 100cc in men 45 years or older (50 years outside U.S.). The UroLift™ System permanent implants, which can be delivered during an outpatient procedure,6 relieve prostate obstruction without heating, cutting, destruction of, or removing prostate tissue. The UroLift™ System can be used to treat a broad spectrum of anatomies, including obstructive median lobe.7 It is the only leading BPH procedure shown to not cause new onset, sustained erectile or ejaculatory dysfunction.**8-9 A study conducted over 5 years showed a low retreatment rate of about 2-3% per year, or a total of 13.6% over the course of the study, demonstrating UroLift™ System durability.10 Most common side effects are temporary and can include hematuria, dysuria, micturition urgency, pelvic pain, and urge incontinence.11 Rare side effects, including bleeding and infection, may lead to a serious outcome and may require intervention. Individual results may vary. The prostatic urethral lift procedure (using the UroLift™ System) is recommended for the treatment of BPH in both the 2021 American Urological Association and 2022 European Association of Urology clinical guidelines. 500,000 men have been treated with the UroLift™ System in select markets worldwide.12 Learn more at www.UroLift.com. Caution: Federal (USA) law restricts this device to sale by or on the order of a physician. About Barrigel™ Rectal SpacerBarrigel™ rectal spacer is the first and only hyaluronic acid rectal spacer that separates the prostate from the rectum to protect the rectum during radiation therapy treatment for prostate cancer.13 Barrigel™ rectal spacer is made from Non-Animal Stabilized Hyaluronic Acid (NASHA).14 Hyaluronic acid is a substance naturally present in the human body and is highly biocompatible and fully absorbable. NASHA has a proven history of safety and efficacy in a wide variety of medical applications in men, women and children worldwide.15-16 Barrigel™ rectal spacer has been proven to significantly reduce unwanted side effects from prostate cancer radiation therapy13 and is cleared for rectal spacing in the United States, Australia, and Europe.17 Barrigel™ rectal spacer is indicated for prostate cancer patients with T1-T3b disease. For more information about Barrigel™ rectal spacer, please visit https://barrigel.com/hcp/barrigel-control-matters. Barrigel™ Rectal Spacer Important Safety InformationBarrigel™ rectal spacer is intended to temporarily position the anterior rectal wall away from the prostate during radiotherapy for prostate cancer and, in creating this space, it is the intent of Barrigel™ rectal spacer to reduce the radiation dose delivered to the anterior rectum. Barrigel™ rectal spacer is composed of biodegradable material and maintains space for the entire course of prostate radiotherapy treatment and is intended to be absorbed by the patient’s body over time. Barrigel™ rectal spacer should only be administered by qualified and properly trained physicians with experience in ultrasound guidance and injection techniques in the urogenital/pelvic area. As with any medical treatment, there are some risks involved with the use of Barrigel™ rectal spacer. Potential complications associated with the use of Barrigel™ rectal spacer include, but are not limited to: pain associated with Barrigel™ rectal spacer injection; needle penetration of the bladder, prostate, rectal wall, rectum, or urethra; injection of Barrigel™ rectal spacer into the bladder, prostate, rectal wall, rectum, urethra, or intravascularly; local inflammatory reactions; infection; urinary retention; rectal mucosal damage, ulcers, necrosis; bleeding; constipation; and rectal urgency. More information on indications, contraindications, warnings and instructions for use can be found in the Instructions For Use at www.barrigel.com. Individual results may vary. Caution: Federal (USA) law restricts this device to sale by or on the order of a physician. About Teleflex Incorporated As a global provider of medical technologies, Teleflex is driven by our purpose to improve the health and quality of people’s lives. Through our vision to become the most trusted partner in healthcare, we offer a diverse portfolio with solutions in the therapy areas of anesthesia, emergency medicine, interventional cardiology and radiology, surgical, vascular access, and urology. We believe that the potential of great people, purpose driven innovation, and world-class products can shape the future direction of healthcare. Teleflex is the home of Arrow™, Barrigel™, Deknatel™, LMA™, Pilling™, QuikClot™, Rüsch™, UroLift™ and Weck™ – trusted brands united by a common sense of purpose. At Teleflex, we are empowering the future of healthcare. For more information, please visit teleflex.com. Forward-Looking Statements Any statements contained in this press release that do not describe historical facts may constitute forward-looking statements. Any forward-looking statements contained herein are based on our management’s current beliefs and expectations, but are subject to a number of risks, uncertainties and changes in circumstances, which may cause actual results or company actions to differ materially from what is expressed or implied by these statements. These risks and uncertainties are identified and described in more detail in our filings with the Securities and Exchange Commission, including our Annual Report on Form 10-K. Teleflex, the Teleflex logo, Arrow, Barrigel, Deknatel, LMA, Pilling, QuikClot, Rüsch, UroLift, and Weck are trademarks or registered trademarks of Teleflex Incorporated or its affiliates, in the U.S. and/or other countries. All other trademarks are the property of their respective owners. © 2025 Teleflex Incorporated. All rights reserved. References *Paid consultants of Teleflex.**No instances of new, sustained erectile or ejaculatory dysfunction in the L.I.F.T. pivotal study †Studies sponsored by Teleflex.‡Sexual function is a combination of MSHQ EjD, MSHQ Bother, and IIEF scores. For overall patient experience, this includes a combination of results from tools to assess Symptoms, QoL, Patient Perception, Goal Achievement, and Sleep. Chughtai et al, AUA 2025. Results from the CLEAR Randomized Controlled Trial (RCT) Suggest Factors Corresponding to Early Patient Satisfaction Are Better Following UroLift PUL Versus Rezum WVTT. †Roehrborn et al, AUA 2025. UroLift™ PUL Demonstrates Significantly Better Efficacy and Patient Experience Outcomes vs. Tamsulosin: Results from the IMPACT RCT.†Roehrborn. Using the American Urological Association Quality Registry (AQUA) BPH Dataset to Assess Early Symptom Improvement after Treatment. Poster presented at AUA; April 26, 2025. Las Vegas, NV.Chao et al, AUA 2025. Safety of Stabilized Hyaluronic Acid (sHA) as a Rectal Spacer: Low Risk of Rectal Wall Infiltration and Reversibility.U.S. 2023 estimates based on US Market Model 2023-25 (3-14-23 FINAL), which is in part based on Symphony Health PatientSource® 2018-22, as is and with no representations/warranties, including accuracy or completeness.Shore, Can J Urol 2014Rukstalis, Prostate Cancer and Prostatic Dis 2018AUA BPH Guidelines 2003, 2020McVary, Urology 2019Roehrborn, Can J Urol 2017Roehrborn, J Urol 2013Management estimate based on product sales as of June 2024. Data on file Teleflex Interventional Urology.Mariados NF, Orio PF III, King MT et al. JAMA Oncol (2023).Barrigel Injectable Gel Instructions for Use (2022).Svatos M, Chell E, Low DA, et al. Symmetry, separation, and stability: Physical properties for effective dosimetric space with a stabilized hyaluronic acid spacer. Med Phys. 2024; 1-15. https://doi-org.libproxy1.nus.edu.sg/10.1002/mp.17292†Restylane® celebrates 25 years of natural-looking results with its signature line of hyaluronic acid fillers. 2021. Available at: https://www.prnewswire.com/news-releases/restylane-celebrates-25-years-of-natural-looking-results-with-its-signature-line-of-hyaluronic-acid-fillers-301388779.html. Accessed Sept 30, 2021.Data on file Teleflex. 2025. MAC03086-01 Rev A Contacts:TeleflexLawrence KeuschVice President, Investor Relations and Strategy Developmentinvestor.relations@teleflex.com610-948-2836 Media Contact:Glenn SilverPartner National Media Relations Specialistglenn.silver@finnpartners.com646-871-8485

Clinical ResultRadiation TherapyClinical Study

02 Apr 2025

·www.prnewswire.com

Hanmi Pharmaceutical's 'Gugutams' to be Launched in Mexico as 'Aditams', Marking the Start of Full-Scale Latin America Expansion

Hanmi Pharm Begins Local Sales of Urological Product 'Aditams' in Mexico with Partner 'Laboratorios Silanes' Launch completed in February, Hanmi Pharm's Third Product to Enter Latin America Aditams, The First Urological Combination Drug for OPG and ED Exported to Mexico SEOUL, South Korea, April 2, 2025 /PRNewswire/ -- Hanmi Pharmaceutical's combination therapy for Obstructive Prostatic Growth (OPG) caused by Benign Prostatic Hyperplasia (BPH) and Erectile Dysfunction (ED), Gugutams, is entering the Mexican market under the local brand name "Aditams." Continue Reading Aditams Hanmi Pharmaceutical announced that it has completed the launch of Aditams in Mexico under the export agreement signed in October 2020 with the Mexican pharmaceutical company 'Laboratorios Silanes'. Under the agreement, Hanmi Pharmaceutical plans to export Gugutams to the Mexican market for a period of seven years, starting in February 2025. Gugutams, developed by Hanmi Pharmaceutical, is the world's first urological combination therapy combining two active ingredients: tamsulosin, a treatment for Obstructive Prostatic Growth (OPG), and tadalafil, a treatment for erectile dysfunction (ED). It is also noteworthy as the first prescription drug in Korea to apply Poly-Cap technology, which integrates multiple active ingredients into a single capsule. Laboratorios Silanes, a leading pharmaceutical company in Mexico founded in 1943, is committed to providing innovative healthcare solutions and driving rapid growth in the industry. It has established itself as a key player in the Latin American pharmaceutical market through its robust distribution network and strategic collaborations with global partners. Silanes previously collaborated with Hanmi Pharmaceutical in 2023 to successfully introduce the hypertension and dyslipidemia combination treatment 'Amosartan Q', under the local brand 'Lodarta' and in 2024 to introduce the combination hypertension treatment 'Amosartan Plus' under the local brand 'Bicartial-CTD'. Following these products, Gugutams, under the local brand 'Aditams', becomes Hanmi Pharmaceutical's third product in the Latin American region. Aditams, as the first urological combination therapy to enter the Mexican market, is expected to offer a new treatment option for patients suffering from both Obstructive Prostatic Growth (OPG) and erectile dysfunction (ED). By managing both conditions with a single medication, it significantly enhances patient convenience and maximizes therapeutic efficacy. Hanmi continues to focus on expanding its partnerships in emerging markets such as the Middle East and Latin America, in addition to its established presence in developed markets like North America and Japan. The company aims to leverage strategic partners like Laboratorios Silanes as key footholds to broaden its product portfolio and regional reach. Park Jae-hyun, CEO of Hanmi Pharmaceutical, stated, "As the first urological combination therapy to enter the Mexican market, Gugutams is expected to present a new treatment paradigm for local patients." He added, "Through this collaboration with Laboratorios Silanes, we aim to solidify Hanmi Pharmaceutical's presence in the Latin American market and leverage this as a foundation to further strengthen our competitiveness in the global pharmaceutical industry." Official Websites: About Hanmi Pharmaceutical: Hanmi Pharmaceutical is an R&D-focused pharmaceutical company committed to developing globally innovative therapies in areas of high unmet medical needs such as obesity/metabolism, oncology, and rare diseases. Hanmi leverages proprietary platform technologies, including long-acting biologics and bispecific antibodies, to address unmet medical needs. The company emphasizes open innovation and has established numerous global partnerships to advance its research and development efforts. SOURCE Hanmi Pharmaceutical WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Drug ApprovalLicense out/inBiosimilar

21 Jun 2024

·pmlive.com

Study suggests enlarged prostate drugs could protect against dementia with Lewy bodies

Researchers from the University of Iowa (UI) Health Care have suggested that certain drugs used to treat enlarged prostates have the potential to decrease the risk of dementia with Lewy bodies (DLB). Published in Neurology , the study revealed that three enlarged prostate drugs were able to increase the energy production in brain cells. Affecting one in every 1,000 people per year, DLB is the second most common type of dementia, which occurs when protein deposits called Lewy bodies develop in nerve cells in the brain, affecting thinking, memory and movement. Researchers identified more than 643,000 men with no history of DLB who were newly starting one of six drugs used to treat benign prostatic hyperplasia and followed the participants for around three years from when they started taking the medication until they left the database or developed DLB. The observational study found that the already-approved Abbott’s Hytrin (terazosin), Pfizer’s Cardura (doxazosin) and Sanofi’s Uroxatral (alfuzosin) boosted the energy production in brain cells, which could help to slow or prevent neurodegenerative diseases including DLB and Parkinson’s disease (PD), while the three other drugs, tamsulosin and two 5-alpha-reductase inhibitors (5ARIs), finasteride and dutasteride, did not. Men who took terazosin had around a 40% lower risk of developing DLB versus men taking tamsulosin and about a 37% reduction in risk compared to men taking 5ARIs, with no statistically significant difference in risk between men taking tamsulosin and ARIs. “If terazosin and these similar medications can help slow this progression – if not outright preventing the disease – this would be important to preserving cognitive function and quality of life in people with DLB,” said lead study author, Jacob Simmering, UI assistant professor, internal medicine. Previous studies have already linked certain drugs and treatments to other neurodegenerative conditions. In February, researchers from University College London revealed that erectile dysfunction drugs could also be linked to a reduced risk of developing Alzheimer’s disease (AD), the most common form of dementia. Of nearly 270,000 men over the age of 40, those who were prescribed phosphodiesterase 5 inhibitors were 18% less likely to develop AD compared to those who were not.

Clinical ResultDrug Approval

100 Deals associated with Tamsulosin Hydrochloride

External Link

KEGG	Wiki	ATC	Drug Bank
D01024	Tamsulosin Hydrochloride	G04CA02	DB00706

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
Lower Urinary Tract Symptoms	Belgium	Astellas Pharma Europe BV	01 Mar 2005
Lower Urinary Tract Symptoms	Luxembourg	Astellas Pharma Europe BV	01 Mar 2005
Hypertension	United States	Sanofi-Aventis U.S. LLC	15 Apr 1997
Prostatic Hyperplasia	Japan	Astellas Pharma, Inc.	02 Jul 1993

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Urological Manifestations	Phase 3	United States	Boehringer Ingelheim GmbH	23 Sep 2015
Urinary Bladder, Neurogenic	Phase 3	United States	Boehringer Ingelheim GmbH	01 Jan 2008
Urinary Bladder, Neurogenic	Phase 3	Belgium	Boehringer Ingelheim GmbH	01 Jan 2008
Urinary Bladder, Neurogenic	Phase 3	Brazil	Boehringer Ingelheim GmbH	01 Jan 2008
Urinary Bladder, Neurogenic	Phase 3	Germany	Boehringer Ingelheim GmbH	01 Jan 2008
Urinary Bladder, Neurogenic	Phase 3	India	Boehringer Ingelheim GmbH	01 Jan 2008
Urinary Bladder, Neurogenic	Phase 3	Italy	Boehringer Ingelheim GmbH	01 Jan 2008
Urinary Bladder, Neurogenic	Phase 3	Mexico	Boehringer Ingelheim GmbH	01 Jan 2008
Urinary Bladder, Neurogenic	Phase 3	Philippines	Boehringer Ingelheim GmbH	01 Jan 2008
Urinary Bladder, Neurogenic	Phase 3	Russia	Boehringer Ingelheim GmbH	01 Jan 2008

Clinical Result

Indication

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Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


P11-3.020 (AAN2025)	Not Applicable	Prostatic Hyperplasia	-	Tamsulosin	ymjqoonhwx(ofrwvltbve): HR = 0.63 (95% CI, 0.53 - 0.76), P-Value = < 0.001 View more	Positive	07 Apr 2025
				5-α reductase inhibitors (5ARI)
NCT03750656 (HyTa Stent, CTgov)	Phase 4	Lower Urinary Tract Symptoms	5	Hyoscyamine (Hyoscyamine)	nywzmuwcdy(vktwnqfcrs) = atbvvdnpfs foilpsvjkz (nbndmgsfvm, vyxxtrbswl - zptggzxsxz) View more	-	03 Dec 2024
				Tamsulosin (Tamsulosin)	nywzmuwcdy(vktwnqfcrs) = sdjzvbllbv foilpsvjkz (nbndmgsfvm, ixbxvrcxns - wbdeiaewlu) View more
NCT01568918 (CTgov)	Phase 3	Urinary Retention	90	Tamsulosin hydrochloride (Tamsulosin)	cdkxlsvuml = udktpxtugc keinjeneop (xhmtzggejh, afecxfpqcc - uipqsnuypn) View more	-	30 May 2024
				Placebo (Placebo)	cdkxlsvuml = niinbjyosb keinjeneop (xhmtzggejh, rweefzpzdj - jxpjqvdgym) View more
MP26-09 (AUA2024)	Not Applicable	-	200	Tamsulosin	ikggzntish(hdpqhfmbir) = exklbuduks ustjmtcect (yxztmpwqlb )	Positive	01 May 2024
				Placebo	ikggzntish(hdpqhfmbir) = tkioauzvmc ustjmtcect (yxztmpwqlb )
NCT04859660 (A Randomized Controlled Trial, CTgov)	Phase 2	Urinary Retention	161	Tamsulosin (Tamsulosin- Intervention Group)	kplqaoeldg(hdbvhvhdjy) = uttshadnyn aktxneryfn (dejymiqqwo, xjioqlxmwi - gbvwzowasu) View more	-	29 Feb 2024
				Placebo (Placebo Group)	kplqaoeldg(hdbvhvhdjy) = yyhpdttzrz aktxneryfn (dejymiqqwo, xofcyabzlw - bdfrbasolv) View more
NCT04682366 (CTgov)	Phase 4	Urinary Retention	4	Tamsulosin (Tamsulosin)	upkdkeswep = mtaosdzcnr gmvillzzvb (bfoqlxpnmj, iuxozlvatk - ojtmncckhl) View more	-	31 Jan 2024
				Placebo (Placebo)	upkdkeswep = zifvmdzstk gmvillzzvb (bfoqlxpnmj, xywjapvsco - lhcgagqwni) View more
MP24-17 (AUA2023)	Not Applicable	Prostatic Hyperplasia	160	Tamsulosin	ujzjvnvqdq(xnadbrjbcn) = gjizarjaiq chaqypdzsh (inwitlsfoz )	-	01 Apr 2023
				Tadalafil 5 mg	ujzjvnvqdq(xnadbrjbcn) = glkwoesdcr chaqypdzsh (inwitlsfoz )
APAO2023	Not Applicable	Intraoperative floppy iris syndrome (IFIS) Tamsulosin	54	Tamsulosin	euwhkbzhff(ujcnoehrfs) = oomzbplniz keubjorsoa (ralduzivhd )	Positive	23 Feb 2023
NCT04819828 (Pubmed \| Int J Clin Pract)	Phase 4	Kidney Calculi Adjuvant	60	Tamsulosin	ogycdcqfau(yrxphkazcg) = sshqmxfujn aqmlfhstap (nokhmchyoi )	Negative	01 Jan 2022
				tamsulosin (Control)	ogycdcqfau(yrxphkazcg) = agujsfnxke aqmlfhstap (nokhmchyoi )
NCT03524339 (CTgov)	Phase 2/3	Pelvic Organ Prolapse \| Urinary Incontinence, Stress \| Urinary Retention ... View more	132	Placebo oral capsule (Placebo)	pgzkerizrv = thmxxqllws smssjolurk (wssavclsmr, smjwvrndqc - kgyhslcxys) View more	-	08 Nov 2021
				Tamsulosin (Tamsulosin)	pgzkerizrv = xzkinrahvj smssjolurk (wssavclsmr, yswjmgfexk - lahjlgqmhx) View more

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