Request Demo

Last update 02 Mar 2026

Silodosin

Last update 02 Mar 2026

Overview

R&D Status

Clinical Result

Translational Medicine

Overview

Basic Info

Drug Type

Small molecule drug

Synonyms

Silodosin (JP17/INN), Silodyx, Thrupas

+ [11]

Target

ADRA1

Action

antagonists

Mechanism

ADRA1 antagonists(Adrenergic receptor alpha-1 antagonists)

Therapeutic Areas

Urogenital Diseases

Active Indication

Prostatic Hyperplasia

Inactive Indication

Calculus, UreteralChronic pelvic pain syndromeChronic prostatitis+ [3]

Originator Organization

Kissei Pharmaceutical Co., Ltd.

Active Organization

Eisai Co., Ltd.

Synmosa Biopharma Corp.Mayne Pharma Group Ltd.

+ [5]

Inactive Organization

AbbVie, Inc.

Actavis, Inc.

Actavis

+ [1]

License Organization

Eisai Co., Ltd.

Daiichi Sankyo Co., Ltd.Actavis Group ehf

+ [1]

Drug Highest PhaseApproved

First Approval Date

South Korea (23 Apr 2008),

Prostatic Hyperplasia

Regulation-

Structure/Sequence

Molecular FormulaC25H32F3N3O4

InChIKeyPNCPYILNMDWPEY-QGZVFWFLSA-N

CAS Registry160970-54-7

112

Clinical Trials associated with Silodosin

CTRI/2025/10/096166

/ RecruitingPhase 2/3

Efficacy Of Oral Silodosin During Peri-Operative Period In Preventing Post-Operative Urinary Retention (POUR) In Spine Surgeries - A Randomised Controlled Trial - NIL

Start Date01 Nov 2025

Sponsor / Collaborator-

TCTR20250528001

/ Not yet recruitingPhase 1

A Single Dose, Randomized, Open-label, Two-way Crossover Bioequivalence Study of Generic Silodosin 4 mg Film-coated Tablets and Reference Product (URIEF Tablets 4 mg) in Healthy Thai Male Volunteers under Fed Conditions

Start Date08 Oct 2025

Sponsor / Collaborator-

NCT07195097

/ Not yet recruitingPhase 1IIT

A Prospective Study to Evaluate the Efficacy of Silodosin 8 mg as an on-Demand, Reversible, Nonhormonal Oral Contraceptive for Males:

In all, 200 healthy, sexually active, fertile male candidates will be assigned 100 in silodosin group and 100 in placebo group. Males using other contraceptive methods will be excluded. Follow up data of total spermatozoa per ejaculate, semen volume and Post-ejaculation urinalysis after 2, 6 and 12 weeks of the studied groups will be recorded. The various side effects reported in the study groups after 12 weeks from the start of the study will be recorded.

Start Date01 Sep 2025

Sponsor / Collaborator

Benha University

100 Clinical Results associated with Silodosin

100 Translational Medicine associated with Silodosin

100 Patents (Medical) associated with Silodosin

587

Literatures (Medical) associated with Silodosin

30 Apr 2026·RAPID COMMUNICATIONS IN MASS SPECTROMETRY

A Novel 1,3‐Sigmatropic Rearrangement in an Iminium Ion Generated in Collision‐Induced Decomposition During Electrospray Ionization High Resolution Multistage Mass Spectrometry

Article

Author: Li, Min ; Chen, Wenbin ; Gao, Zhiyuan ; Zhang, Juan ; Zhang, Junjun ; Bai, Zhengwu ; Xi, Jiangbo

ABSTRACT:

Rationale:

Rapid structural elucidation of unknown pharmaceutical impurities is critical throughout the whole life cycle of drug development. It can be achieved by using multistage mass spectrometric analysis, in conjunction with the understanding of dissociation mechanisms of the ions generated by electrospray ionization.

Methods:

Liquid chromatography‐UV/photo diode array detection—high resolution multistage mass spectrometric analysis (HiRes MS n ) was used to elucidate the structure of an impurity of silodosin. The structure was confirmed by 1D and 2D NMR spectroscopy.

Results:

The impurity is identified as N ‐cyanomethylsilodosin, a solution degradant of silodosin. A novel 1,3‐sigmatropic rearrangement was observed during one of its MS 3 dissociation pathways. A mechanism is proposed for the 1,3‐sigmatropic rearrangement, which is supported by the MS n behavior of a 13 C‐isotope labeled derivative of N ‐cyanomethylsilodosin.

Conclusion:

Elucidation of such an intra‐molecular rearrangement mechanism not only enriches our understanding of the gas phase dissociation chemistry, but also should facilitate future rapid structural characterization of unknown pharmaceutical impurities and metabolites using multistage mass spectrometric analysis.

02 Jan 2026·Arab Journal of Urology

Efficacy of alpha-blockers in medical expulsive therapy for ureteral stones: A systematic review and meta-analysis of randomized controlled trials between 2010 and 2025

Review

Author: Almurshed, Oroub Abdulaziz ; Alshammari, Adel H. ; Alsulami, Yazeed Dakhel ; Alkharboosh, Abdullah Sulaiman ; Alruhaili, Wijdan Ateeq Allah ; Alotaibi, Eman Abdullah ; Alomari, Renad Wesam ; Alotaibi, Mohammed Saad ; Almaghthawi, Mohammed Marzouq ; Alahamdi, Manar Ali ; Aljaddua, Salem Ibrahim S ; Hijazi, Eyad Mohammed

Introduction:

Alpha-blockers are widely used in medical expulsive therapy (MET) for ureteral stones; however, the current evidence regarding their comparative effectiveness remains inconsistent. We aimed to evaluate the efficacy and safety of different alpha-blockers in facilitating ureteral stone passage and identify factors influencing treatment outcomes.

Methods:

We conducted a systematic review and meta-analysis of randomized controlled trials (RCTs) published between 2010 and 2025. We searched multiple databases for studies comparing alpha-blockers with control interventions or other alpha-blockers for ureteral stones ≤10 mm. Primary outcome was stone expulsion rate; secondary outcomes included time to expulsion, pain episodes, analgesic use, and adverse events. We performed subgroup analyses by alpha-blocker type, stone size, location, and treatment duration. Network meta-analysis assessed comparative effectiveness between agents.

Results:

Twenty-nine RCTs with a total of 4,256 patients were included. Alpha-blockers significantly increased stone expulsion rates compared to controls (70.9% vs. 56.5%; RR 1.25, 95% CI 1.20-1.32; Number Needed to Treat (NNT) = 7) and reduced expulsion time by approximately three-days. Efficacy was greatest for distal ureteral stones (RR 1.52; Number Needed to Treat (NNT) = 4) and stones 5-10 mm (RR 1.35; NNT = 6). Network meta-analysis revealed efficacy ranking favoring at first terazosin, followed by doxazosin then, silodosin then, tamsulosin then, alfuzosin and last the least effective was naftopidil. Alpha-blockers significantly reduced pain episodes and analgesic requirements. Adverse events were infrequent (Number Needed to Harm (NNH) = 38), with retrograde ejaculation being most common with silodosin.

Conclusion:

Alpha-blockers significantly improve the stone expulsion rates and reduce expulsion time, especially for distal ureteral stones 5-10 mm in size. While tamsulosin remains the most studied agent, our network meta-analysis suggests terazosin and doxazosin may offer superior efficacy. The favorable risk-benefit profile supports routine use of alpha-blockers for appropriately selected patients with ureteral stones.

01 Jan 2026·NEUROUROLOGY AND URODYNAMICS

Global Consensus on Interstitial Cystitis/Bladder Pain Syndrome: An Update on Therapeutic Treatments

Review

Author: Peters, Kenneth M. ; Jacques, Wyndaele Jean ; Pinto, Rui Almeida ; Mishra, Nagendra Nath ; Birder, Lori ; Riedl, Claus ; Lovász, Sándor ; Buford, Karis

ABSTRACT:

Aims:

Interstitial cystitis/bladder pain syndrome (IC/BPS) is a chronic condition marked by chronic pain and voiding dysfunction, often without a clear cause. Management of which often requires a multidisciplinary approach, as well as multiple therapeutic interventions.

Methods:

This review characterizes mechanisms and limitations of currently available treatment modalities for IC/BPS, as well as novel and investigational therapies.

Results:

Conservative and supportive therapies include cognitive therapies, dietary and fluid management, pelvic floor exercises and bladder training. Additionally, pelvic floor directed therapies such as physical therapy, injections and nerve blocks should be considered. Cystoscopy with hydrodistension is both a diagnostic and therapeutic intervention. Currently available oral therapies include: pentosan polysulfate, amitriptyline, hydroxyzine, silodosin, and non‐opioid medications such as cyclobenzaprine. Immunotherapies include cyclosporine and tacrolimus. Available intravesical therapies include dimethyl sulfoxide, lidocaine, oxybutynin, and glycosaminoglycan substitution treatment. Neuromodulation is also available including sacral and pudendal neuromodulation. Finally, we explore emerging therapies and drug delivery systems.

Conclusions:

In this review, we present currently available treatment options for IC/BPS. These include conservative therapies, oral medications, intravesical therapies, and neuromodulation. Novel and investigational therapies are presented as well as promise for future directions.

News (Medical) associated with Silodosin

17 Feb 2026

·www.biospace.com

RECORDATI REPORTS STRONG PRELIMINARY FULL YEAR 2025 RESULTS: REVENUE +11.8%, EBITDA(1) +14.5%, ADJUSTED NET INCOME(2) +14.5%

Consolidated net revenue of € 2,618.4 million for full year 2025, +11.8% or +8.3% on a like-for-like basis (3) at constant exchange rates (CER) EBITDA (1) of € 991.1 million, +14.5%, margin on net revenue of 37.8% Adjusted net income (2) of € 651.1 million, +14.5%, margin on net revenue of 24.9% Net income of € 443.6 million, +6.5% Free cash flow (4) of € 558.8 million, +€ 23.7 million reflecting strong EBITDA partially offset by U.S. inventory build-up, higher interests and income tax paid Net debt (5) at € 2,037.3 million, just below 2.1x EBITDA FY 2026 financial targets: Net revenue € 2,730-€2,800 million with FX headwind of ~-3.5% ; EBITDA (1) € 995-€1,030 million, margin +/- 36.5% ; Adjusted net income (2) € 655-€ 685 million, margin +/- 24.0% In January 2026, the Group received a B‑ rating with ‘Prime’ status from ISS ESG, recognizing its leading sustainability performance within the industry Milan, February 17, 2026 – The Board of Directors of Recordati S.p.A. has reviewed and approved the preliminary consolidated financial statements for 2025. The Group’s final consolidated annual financial statements for 2025 will be submitted to the Board of Directors for approval on March 19, 2026. Rob Koremans, Chief Executive Officer of Recordati, commented: “2025 was another year of solid progress across the business, reflecting the strength of our execution. We delivered once again on our financial targets despite a challenging macroenvironment, including increased FX headwinds. During the year, we further strengthened our portfolio through strategic partnerships in both Rare Diseases and Specialty and Primary Care. There is excellent momentum in Rare Diseases, which continues to be a key driver of growth and value creation for the Group. We are excited by Isturisa’s opportunity to address the broader Cushing’s syndrome market, with uptake accelerating in the U.S. With such a strong foundation in place, we expect 2026 to be another year of disciplined execution as we continue to deliver on our strategic objectives, maintain sector-leading margins and create sustainable value for all our stakeholders.” Financial highlights Consolidated net revenue for full year 2025 was € 2,618.4 million, up 11.8% versus full year 2024 or 8.3% on a like-for-like (3) basis at CER, driven by solid contribution from both Specialty & Primary Care and Rare Diseases. The adverse FX impact for full year 2025 was € 64.2 million (-2.7%). Specialty & Primary Care revenue was € 1,477.9 million for full year 2025, up 2.0% or 3.8% on a like-for-like basis (3) at CER (+1.6% excluding Türkiye). This reflects continued positive performance of all core therapeutic areas (promoted product evolution index of 105), despite a slight slowdown in relevant market growth. In particular, the Urology and Cardiovascular franchises grew 2.5% and 2.8%, respectively, while the Gastrointestinal franchise grew 9.9%, driven by the strong in-market performance of several products in the portfolio, both prescription and OTC. Rare Diseases revenue was € 1,081.4 million for full year 2025, up 29.7% as compared to full year 2024, or 16.6% on a like-for-like (3) basis at CER, driven by strong volume growth across all three franchises. The Endocrinology franchise achieved net revenue of € 394.1 million, an increase of 22.5%, reflecting an acceleration of new patient uptake of Isturisa ® in the U.S. in the second half of 2025 with approximately 1,400 net active patients at the end of the year, as well as double-digit growth of Signifor ® . The Hema-Oncology franchise achieved net revenue of € 414.9 million, growing by 63.8%, reflecting the contribution of Enjaymo ® of € 146.3 million (+26.7% vs full year 2024 proforma (6) ), and driven by strong growth of Sylvant ® and Qarziba ® . The Metabolic franchise achieved net revenue of € 272.5 million, sustaining mid-single digit growth of 5.2%, driven by Carbaglu ® and Panhematin ® . Adjusted operating income (7) was € 774.9 million for full year 2025, up 13.2% over full year 2024, and 29.6% of net revenue versus 29.2% in the previous year. Operating income was € 670.8 million for full year 2025, up 5.0% over full year 2024, absorbing gross margin-related non-cash charges of € 66.8 million as compared to € 37.5 million for full year 2024, arising from the unwind of the fair value step up of acquired Rare Diseases inventory including € 62.5 million for Enjaymo ® . Non-recurring costs were € 37.3 million for full year 2025, versus € 8.0 million for full year 2024. These costs reflect primarily the continued optimization of the Specialty and Primary Care commercial organization, mainly in Italy and Spain. The non‑recurring costs also include a one‑off provision of €12.8 million (8) related to the settlement of a litigation case with AIFA concerning prior years payback for Urorec ® . Additionally, non‑recurring items include the impact of the ongoing voluntary liquidation of the Rare Diseases subsidiary in China, following the rejection of the National Reimbursement Drug List approval for Isturisa ® . The availability of Qarziba ® and Sylvant ® in the territory continues to be provided through a local distributor. EBITDA (1) was € 991.1 million for full year 2025, up 14.5% compared to full year 2024, with margin on net revenue of 37.8%. The improvement over the prior year was driven by a positive business mix and strong operating performance across both business units, despite the significant foreign exchange headwinds and higher investments to support the U.S. launch of the expanded Isturisa ® label, the continued development of Enjaymo ® and ongoing geographic expansion in Rare Diseases. Financial expenses were € 89.5 million for full year 2025, down by € 2.1 million as compared to full year 2024. New loans obtained in 2024, related to the acquisition of Enjaymo ® , and in 2025 led to an increase in interest expenses of € 17.4 million. Net exchange gains over the period were € 15.0 million (mainly unrealized and driven by the devaluation of the U.S. dollar), against net FX losses of € 9.3 million in FY 2024. This was partly offset by € 5.3 million of net monetary losses from hyperinflation accounting (compared to a loss of € 6.7 million in full year 2024) mainly driven by the net effect of the revaluation of Turkish balance sheet items. Adjusted Net Income was € 651.1 million, 24.9% of revenue, up by 14.5% compared to full year 2024. This growth reflects improvements in adjusted operating income as well as lower financial expenses partially offset by higher income taxes. Net income was € 443.6 million, 16.9% of revenue, increasing by 6.5% versus full year 2024, mainly driven by the higher operating income and lower financial expenses. Free cash flow (4) was € 558.8 million for full year 2025, an increase of € 23.7 million versus full year 2024, with strong EBITDA partially offset by higher working capital absorption (mainly driven by higher U.S. inventory levels), higher interests and income tax paid. Net debt (5) as of December 31, 2025 was € 2,037.3 million, or leverage of just below 2.1x EBITDA, compared to net debt of € 2,154.3 million on December 31, 2024, following dividend payments of € 267.6 million, treasury shares purchased for € 112.5 million (net of proceeds from exercising stock options), the upfront payment for Vazkepa ® rights of USD 25 million and the upfront payment for Inrebic ® rights of USD 11 million. Shareholders’ equity was € 1,919.8 million. Pipeline Update On April 15, 2025, the U.S. Food and Drug Administration (FDA) approved the supplemental new drug application (sNDA) for Isturisa ® (osilodrostat) for the treatment of endogenous hypercortisolemia in adults with Cushing’s syndrome for whom surgery is not an option or has not been curative. This was an expansion of the previous indication for the treatment of patients with Cushing’s disease, which is a sub-type of Cushing’s syndrome. The Isturisa ® indication expansion was supported by the extensive Isturisa ® clinical development program, which included over 350 patients. In addition, during the second quarter of 2025, Isturisa ® was granted regulatory approval in both Canada and Russia. A Phase IV study to assess the efficacy and safety of osilodrostat in adults with mild hypercortisolemia and uncontrolled hypertension (HTN) due to Cushing’s syndrome is expected to start in 2026. During the second quarter of 2025, an investigator-sponsored clinical trial (IST) was initiated to investigate the safety, dose and early signs of effect for dinutuximab beta (Qarziba ® ) in combination with chemotherapy for the treatment of patients with GD2-positive Ewing sarcoma. On July 28, 2025, the European Commission issued a positive decision and granted marketing authorization, under exceptional circumstances, for Maapliv ® , a solution of amino acids intended for the treatment of maple syrup urine disease (MSUD) presenting with an acute decompensation episode in patients from birth who are not eligible for an oral and enteral branched-chain amino acids (BCAA)-free formulation. The Company completed enrollment of the pasireotide Phase 2 trial for the treatment of post-bariatric hypoglycemia in August 2025. Top-line results are expected in the second quarter of 2026. Following the meeting with the U.S. Food and Drug Administration (FDA) in early September, a potential U.S. biologics license application (BLA) pathway was established with the FDA for Qarziba ® requiring an additional set of clinical data from the ongoing BEACON-2 investigator-sponsored trial. Results of the interim analysis are expected in the first half of 2028 and are expected to form the basis, together with existing clinical data, for a potential regulatory filing. On January 5, 2026, the UK Medicines and Healthcare products Regulatory Agency (MHRA) granted marketing authorization for Eligard ® for the treatment of hormone dependent advanced prostate cancer and for the treatment of high-risk localized and locally advanced hormone dependent prostate cancer in combination with radiotherapy. The other lifecycle management programs are progressing in line with plans. Corporate Development On June 24, 2025, Recordati announced a licensing and supply agreement with Amarin to commercialize the marketed cardiovascular medicine, Vazkepa ® (icosapent ethyl) across 59 countries, focused in Europe. Vazkepa ® is indicated to reduce the risk of cardiovascular events in statin-treated adult patients at high cardiovascular risk with elevated triglycerides and either established cardiovascular disease or diabetes with at least one other cardiovascular risk factor. Vazkepa ® is expected to achieve over € 40 million in revenues in 2027 and to be EBITDA positive from 2026. Under the terms of the agreement, Recordati paid Amarin an upfront cash payment of USD 25 million. On December 17, 2025, Recordati announced the exclusive license agreement with Impact Biomedicines, Inc., a Bristol Myers Squibb subsidiary, and the related supply agreement with Celgene Logistics Sàrl to commercialize Inrebic ® (fedratinib dihydrochloride monohydrate) in Japan. Impact Biomedicines, Inc. will retain exclusive rights to develop and commercialize Inrebic® in the rest of the world. Inrebic ® is an oral kinase inhibitor with activity against wild-type and mutationally activated JAK2 to suppress the pathological features of myelofibrosis patients. Inrebic ® received regulatory approval from the Ministry of Health, Labour and Welfare (MHLW) in Japan in June 2025 for the treatment of myelofibrosis and is expected to launch in mid 2026. Under the terms of the agreement, Recordati paid Impact Biomedicines, Inc. an upfront payment of USD 11 million. On January 29, 2026, Recordati announced a collaboration and license agreement with Moderna to develop and commercialize worldwide mRNA-3927, an investigational product for the treatment of propionic acidemia (PA). Under the terms of the agreement, Moderna will continue to lead the development of mRNA-3927, in collaboration with Recordati, and if approved, Recordati will lead global commercialization. mRNA-3927 is a post proof-of-concept, investigational product aimed to restore propionyl-CoA carboxylase (PCC) enzyme activity in patients with propionic acidemia. If approved, this could be the first disease-modifying treatment option on the market for this severe disease. mRNA-3927 is currently being evaluated in a potential registrational clinical study. The target patient enrollment has been reached, with a potential data readout expected by the end of 2026. Under the terms of the agreement, Recordati will pay Moderna an upfront payment of USD 50 million and up to an additional USD 110 million in near-term development and regulatory milestones. Moderna is also eligible to receive commercial and sales milestones, as well as tiered royalties on annual net sales. Recordati does not expect any significant impact on its EBITDA prior to a potential launch. Business outlook The financial targets for full year 2026 are as follows: Net revenue between € 2,730 and € 2,800 million with FX headwind of ~-3.5% EBITDA (1) between € 995 and € 1,030 million; margin of +/- 36.5% Adjusted net income (2) between € 655 and € 685 million; margin of +/- 24.0% The full year 2027 targets (9) remain unchanged, with strong organic growth complemented by bolt-on BD and M&A. (1) Net income before income taxes, financial income and expenses, depreciation, amortization and write-downs of property, plant and equipment, intangible assets and goodwill, non-recurring items and non-cash charges arising from the allocation of the purchase price of acquisitions to the gross margin of acquired inventory as foreseen by IFRS (2) Net income excluding amortization and write-downs of intangible assets (except software) and goodwill, non-recurring items, non-cash charges arising from the allocation of the purchase price of acquisitions to the gross margin of acquired inventory as foreseen by IFRS 3, monetary net gains/losses from hyperinflation (IAS 29), net of tax effects. (3) Proforma growth calculated excluding revenue of Vazkepa® for FY 2025 (Specialty & Primary Care) and Enjaymo® for both FY 2025 and FY 2024 (Rare Diseases) (4) Total cash flow excluding financing items, milestones, dividends, purchases of treasury shares net of proceeds from exercise of stock options. (5) Cash and cash equivalents, less bank debts and loans, which include the measurement at fair value of hedging derivatives. (6) Comparing FY 2025 revenue (which considers also the margin retained by Sanofi’s on in market sales for those countries where it was still holding the MA) with proforma FY 2024 revenue also including sales totally realized by Sanofi. (7) Net income before income taxes, financial income and expenses and non-recurring items, non-cash charges arising from the allocation of the purchase price of acquisitions to the gross margin of acquired inventory as foreseen by IFRS 3. (8) The provision has been revised since September to reflect the terms of the final settlement agreement with AIFA (9) FY 2027 targets: Net Revenue €3,000 - €3,200 million, EBITDA €1,140 - €1,225 million, Adjusted Net Income €770- €820 million, excluding potential impact from tariffs and/or most favored nation pricing policies in the U.S. Conference Call Recordati will host a conference call on February 18 th , at 2:00 p.m. CET ( 1:00 p.m. GMT ) to present the results for full year 2025. Please find the pre-registration link here with all the dial-in details and a calendar invitation to follow. Alternatively, if not pre-registered, the dial-in numbers for the conference call are: Italy + 39 02 802 09 11, toll free 800 231 525 UK + 44 1 212818004, toll free (44) 0 800 0156371 USA +1 718 7058796, toll free (1) 1 855 2656958 France +33 1 70918704 Germany +49 6917415712 Participants are invited to dial in 10 minutes before the start of the conference call. If operator assistance is required to connect, please dial *0. The slides that will be referenced during the call will be available at under Investors/Company Presentations. Recordati is an international pharmaceutical group listed on the Italian Stock Exchange (XMIL: REC), with roots dating back to a family-run pharmacy in Northern Italy in the 1920s. We are uniquely structured to provide treatments across specialty and primary care, and rare diseases. Our fully integrated operations span clinical development, chemical and finished product manufacturing, commercialization and licensing. We operate in approximately 150 countries across EMEA, the Americas and APAC with over 4,500 employees. We believe that health is a fundamental right, not a privilege. Today, our purpose of “unlocking the full potential of life” aims at empowering individuals to live life to the fullest, whether addressing common health challenges or the rarest. Investor Relations Eugenia Litz eugenia.litz@recordati.com Gianluca Saletta saletta.g@recordati.it Media Relations Laura Conti conti.l@recordati.it Rebecca Kerr rebecca.kerr@recordati.com This document contains forward-looking statements relating to future events and future operating, economic and financial results of the Recordati group. By their nature, forward-looking statements involve risk and uncertainty because they depend on the occurrence of future events and circumstances. Actual results may therefore differ materially from forecasts for a variety of reasons, most of which are beyond the Recordati group ’ s control. The information on the pharmaceutical specialties and other products of the Recordati group contained in this document is intended solely as information on the activities of the Recordati Group, and, as such, it is not intended as a medical scientific indication or recommendation, or as advertising . DECLARATION BY THE FINANCIAL REPORTING OFFICER The Financial Reporting Officer, Niccolò Giovannini, declares, pursuant to paragraph 2 of Article 154- bis of the Consolidated Law on Finance, that the accounting information contained in this press release corresponds to the Company’s documentation, books and accounting records. RECORDATI INDUSTRIA CHIMICA E FARMACEUTICA S.p.A. Registered Office Via Matteo Civitali, 1 20148 Milano, Italy Tel. +39 02 487871 Fax +39 02 40073747 Share Capital € 26.140.644,50 fully paid-up Milano, Monza, Brianza and Lodi Comp. Reg. No. 00748210150 Tax Code/VAT No. 00748210150 Milano R.E.A. No. 401832 Company subject to the Management and Coordination Activity of Rossini Luxembourg S.àr.l

License out/inDrug ApprovalPhase 2Financial Statement

30 Oct 2023

·www.biospace.com

Petros Pharmaceuticals Petros Pharmaceuticals Developing Artificial Intelligence Technology for Phase 2 Equivalent Study for STENDRA(R)

New AI/machine learning tool designed to help potential users more effectively self-select in the effort to make STENDRA the first erectile dysfunction (ED) medication available OTC Petros in discussions with third-party technology partners NEW YORK, NY / ACCESSWIRE / October 30, 2023 / Petros Pharmaceuticals, Inc. (NASDAQ:PTPI), ), a company focused on expanding consumer access to medication through over-the- counter (OTC) drug development programs, announces the development of a technological component of its self-selection study utilizing machine learning/artificial intelligence (AI), which the Company plans to integrate into its self-selection studies for its erectile dysfunction drug STENDRAÒ (avanafil). The development of the technology and study design will continue to follow direct U.S. Food and Drug Administration (FDA) recommendations as well as published proposed guidelines currently being finalized by the Agency. Fady Boctor, Petros' President and Chief Commercial Officer, commented, "We are developing this technology component using AI/machine learning in response to FDA feedback to provide an automated screening mechanism that should enhance the self-selection process and help mitigate that only men who are appropriate to use STENDRA should be able to gain access to the medication. We anticipate advancing the development of this technology tool leveraging the guidance we have already received from the FDA. In addition, we believe it will likely be refined and completed through third-party technology partnerships." In addition to providing encouraging guidance about the STENDRA Drug Facts Label (DFL), paving the way for initiating Petros' Self-Selection Studies (SSS), the FDA provided specific guidance regarding what it would expect of the technology component. This feedback is in addition to general guidance from the FDA regarding Additional Conditions for Nonprescription Use (ACNU) criteria that enable correct self-selection by consumers. Furthermore, it may expand OTC access to medications that formerly could only be available by prescription. An ACNU may be an innovative computerized tool, or the additional conditions may use other approaches that support the switch process. Mr. Boctor continued, "We continue to benefit from the FDA's guidance in our quest to make STENDRA the first erectile dysfunction drug to achieve OTC status in the United States. As previously disclosed, if we achieve positive self-selection data, including a proper testing of the technology component, and upon FDA clearance, we expect to move expeditiously into an actual use trial, akin to a Phase 3 registration trial in clinical development sequencing. We continue to believe our developmental methodology - which would include this AI-driven technology - may ultimately become a model for future programs seeking to switch prescription products to OTC marketing status," concluded Mr. Boctor. About Petros Pharmaceuticals Petros Pharmaceuticals is committed to the goal of becoming a leading innovator in the emerging self-care market driving expanded access to key prescription pharmaceuticals as Over-the-Counter treatment options. Currently, Petros is pursuing increased access for its flagship prescription ED therapy, STENDRA, via potential OTC designation. If ultimately approved by the FDA for OTC access, STENDRA may be the first in its class to achieve this marketing status, also establishing company know how as a proven platform for other prospective prescription therapeutics. About the OTC Pathway The process of switching a prescription medication to over-the-counter (OTC) first involves the design of a Drug Facts Label (DFL) that is well understood by potential consumers. Then data must show that consumers can make an appropriate decision to use or not to use the product based only upon the information on the DFL and their personal medical history. Then consumers must demonstrate that they can properly use the product based upon the information on the DFL. To accomplish these things, the FDA ordinarily requires a consumer tested OTC DFL. This testing includes conduct of iterative Label Comprehension Studies (LCS) in the general population, Self-Selection Studies (SSS) in a population interested in using the product and in specific populations who may be harmed if they use the product, and usually one Actual Use Trial (AUT) demonstrating safe and appropriate use by consumers in a simulated OTC setting. The regulations that FDA is currently finalizing introduced Additional Conditions for Nonprescription Use (ACNU) criteria that enable correct self-selection by consumers and may expand OTC access to medications that formerly could only be available by prescription. An ACNU may be an innovative computerized tool, or the additional conditions may use other approaches that support the switch process. About STENDRA® (avanafil) Stendra® (avanafil), originally launched by Auxilium Pharmaceuticals prior to that company's sale to Endo Pharmaceuticals, is an oral phosphodiesterase 5 (PDE5) inhibitor for the treatment of erectile dysfunction. STENDRA is not for use in women or children. It is not known if STENDRA is safe and effective in women or children under 18 years of age. (A 100-mg and 200-mg tablet can be taken as early as ~15 minutes before sexual activity. STENDRA only works with sexual stimulation and should not be taken more than once a day. STENDRA can be taken with or without food; do not drink too much alcohol when taking STENDRA (for example, more than 3 glasses of wine or 3 shots of whiskey) as it can increase chances of side effects. Of people enrolled in clinical trials, 1.4%, 2.0%, and 2.0%, respectively, stopped taking STENDRA (50 mg, 100 mg, or 200 mg) due to side effects compared to 1.7% on placebo. Stendra® was designed and developed expressly for erectile dysfunction. The Company recently undertook a relaunch of Stendra®, generating gross revenues of approximately $30 million in 2019. Petros intends to accelerate the relaunch of Stendra® with a well-funded commercial organization and refocused strategy. STENDRA Important Risk Information STENDRA can cause your blood pressure to drop suddenly to an unsafe level if it is taken with certain other medicines. A sudden drop in blood pressure can cause you to feel dizzy, faint, or have a heart attack or stroke. Do not take STENDRA if you: take medicines called nitrates, which are used to treat chest pain (angina) use street drugs called "poppers," such as amyl nitrate and butyl nitrate take medicines called guanylate cyclase stimulators, which include Adempas® (riociguat), a medicine that treats pulmonary arterial hypertension and chronic thromboembolic pulmonary hypertension are allergic to avanafil or any of the ingredients in STENDRA Stop sexual activity and get medical help right away if you have symptoms such as chest pain, dizziness, or nausea during sex. Sexual activity can put an extra strain on your heart, especially if your heart is already weak from a heart attack or heart disease. Discuss your health with your healthcare provider to ensure you are healthy enough for sex. STENDRA can cause serious side effects. Uncommonly reported side effects include: An erection that will not go away (priapism). If you have an erection that lasts more than 4 hours, get medical help right away. Sudden vision loss in one or both eyes. Sudden vision loss in one or both eyes can be a sign of a serious eye problem called non-arteritic anterior ischemic optic neuropathy (NAION). It is uncertain whether PDE5 inhibitors directly cause vision loss. Stop taking STENDRA and call your healthcare provider right away if you have sudden vision loss in one or both eyes. Sudden hearing decrease or hearing loss. Some people may also have ringing in their ears (tinnitus) or dizziness. Before you take STENDRA, tell your healthcare provider if you: have or have had heart problems such as a heart attack, irregular heartbeat, angina, or heart failure; have had heart surgery within the last 6 months; have had a stroke; have low blood pressure, or high blood pressure that is not controlled; have a deformed penis shape have had an erection that lasted for more than 4 hours; have problems with your blood cells, such as sickle cell anemia, multiple myeloma, or leukemia; have retinitis pigmentosa, a rare genetic (runs in families) eye disease; have ever had severe vision loss, including an eye problem called non-arteritic anterior ischemic optic neuropathy (NAION); have bleeding problems; have or have had stomach ulcers; have liver problems; have kidney problems or are having kidney dialysis; or have any other medical conditions Tell your healthcare provider about all of the medicines you take, including prescription and nonprescription medicines, vitamins, and herbal supplements. STENDRA may affect the way other medicines work, and other medicines may affect the way STENDRA works, which may cause side effects. Especially tell your healthcare provider if you take any of the following: medicines called nitrates medicines called guanylate cyclase stimulators, such as riociguat medicines called HIV protease inhibitors, such as ritonavir (Norvir®), indinavir (Crixivan®), saquinavir (Fortavase® or Invirase®), or atazanavir (Reyataz®) some types of oral antifungal medicines, such as ketoconazole (Nizoral®) and itraconazole (Sporanox®) some types of antibiotics, such as clarithromycin (Biaxin®), telithromycin (Ketek®), or erythromycin medicines called alpha-blockers. These include terazosin (Hytrin®), tamsulosin HCl (Flomax®), doxazosin (Cardura®), prazosin HCl (Minipress®), alfuzosin HCl (UroXatral®), dutasteride and tamsulosin HCl (Jalyn®), or silodosin (Rapaflo®). Alpha-blockers are sometimes prescribed for prostate problems or high blood pressure. In some patients, the use of STENDRA with alpha-blockers can lead to a drop in blood pressure or fainting other medicines that treat high blood pressure other medicines or treatments for ED Do not drink too much alcohol (for example, more than 3 glasses of wine or 3 shots of whiskey) when taking STENDRA, as this can lead to increased chances of headache, dizziness, increased heart rate, or lowered blood pressure. STENDRA does not protect against sexually transmitted diseases, including HIV. The most common side effects of STENDRA are headache, flushing, stuffy or runny nose, sore throat, and back pain. Tell your healthcare provider if you have any side effect that bothers you or does not go away. These are not all of the possible side effects of STENDRA. For more information, ask your healthcare provider or pharmacist. Call your healthcare provider for medical advice about side effects. STENDRA is a prescription medicine used to treat erectile dysfunction (ED). STENDRA is not for use in women or children. It is not known if STENDRA is safe and eﬀective in women or children under 18 years of age. For more information about Stendra, call 844-458-4887. If you would like to report an adverse event or product compliant, please contact us at 844-458-4887. You are encouraged to report adverse events related to prescription drugs to the FDA. Visit or call 1-800-FDA-1088. Please see full Prescribing Information and Patient Information. Cautionary Note Regarding Forward-Looking Statements This press release includes forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. These forward-looking statements are based upon Petros Pharmaceuticals, Inc.'s ("Petros," "we," "our," "us" or the "Company") management's assumptions, expectations, projections, intentions, and beliefs about future events. In some cases, predictive, future-tense or forward-looking words such as "intend," "develop," "goal," "plan," "predict", "may," "will," "project," "estimate," "anticipate," "believe," "expect," "continue," "potential," "opportunity," "forecast," "should," "target," "strategy" and similar expressions, whether in the negative or affirmative, that reflect our current views with respect to future events and operational, economic and financial performance are intended to identify forward-looking statements, but are not the exclusive means of identifying such statements. Such forward-looking statements are only predictions, and actual results and the timing of certain events and circumstances may differ materially from those described by the forward-looking statements as a result of risks and uncertainties, Petros' ability to execute on its business strategy, including its plans to develop and commercialize its product candidates; Petros' ability to comply with obligations as a public reporting company; Petros' ability to maintain compliance with the Nasdaq Stock Market's listing standards; risks related to Petros' ability to continue as a going concern; risks related to Petros' history of incurring significant losses; risks related to Petros' dependence on the commercialization of a single product, STENDRA®; and risks related to Petros' ability to obtain regulatory approvals for, or market acceptance of, any of its products or product candidates. Additional factors that could cause actual results to differ materially from the results anticipated in these forward-looking statements are contained in the Company's periodic reports and in other filings that the Company has or may file, with the U.S. Securities and Exchange Commission (the "SEC") under the headings "Risk Factors" and "Management's Discussion and Analysis of Financial Condition and Results of Operations" and elsewhere. The Company cautions readers that the forward-looking statements included in this press release represent our beliefs, expectations, estimates and assumptions only as of the date of hereof and are not intended to give any assurance as to future results. New factors emerge from time to time, and it is not possible for us to predict all of these factors. Further, the Company cannot assess the effect of each such factor on our business or the extent to which any factor, or combination of factors, may cause actual results to be materially different from those contained in any forward-looking statement. Accordingly, you should not unduly rely on any forward-looking statements. The Company undertakes no obligation to update or revise any forward-looking statements contained in this press release, whether as a result of new information, future events, a change in our views or expectations or otherwise, except as required by federal securities laws. Contacts Investors: CORE IR ir@petrospharma.com Media: Jules Abraham CORE IR 917-885-7378 pr@coreir.com SOURCE: Petros Pharmaceuticals, Inc. View source version on accesswire.com:

Phase 2Phase 3

19 Oct 2023

·www.biospace.com

Following Encouraging FDA Feedback Petros Pharmaceuticals Initiates Self-Selection (Phase 2-Equivalent) Study for STENDRA

Important step towards STENDRA potentially becoming the first erectile dysfunction medication to successfully achieve OTC Status NEW YORK, NY / ACCESSWIRE / October 19, 2023 / Petros Pharmaceuticals, Inc. (NASDAQ:PTPI), a company focused on expanding consumer access to medication through over-the-counter (OTC) drug development programs, announces initiation of a self-selection study using the Drug Facts Label (DFL) tested during its previously announced label comprehension study (LCS). Fady Boctor, Petros' President and Chief Commercial Officer, commented, "We continue to collaborate with the FDA as we pursue an emerging pathway to expand access to STENDRA as the first potential OTC prescription-grade therapeutic option for erectile dysfunction (ED). We believe we have sufficient funding to achieve our development goals as well as significant near-term clinical milestones for STENDRA." Petros now launches this self-selection study in a simulated OTC setting that allows potential users to determine if they are appropriate candidates to use STENDRA based on their understanding of the label and personal medical history. This study is akin to a Phase 2 study in clinical development sequencing and is the next step in the Company's FDA-guided pathway towards a possible OTC version of STENDRA, the Company's prescription erectile dysfunction drug. At a recent meeting with the Company, the FDA provided encouraging guidance about the STENDRA DFL, paving the way for Petros to enter the next phase of research in the OTC development program, a Self-Selection Study (SSS). The FDA was forthcoming about its appreciation of the potential public health benefit of addressing men's sexual health with nonprescription medication to treat ED. Mr. Boctor continued, "This next phase of research, the SSS, will also explore a technology component that may optimize the self-selection results. We look forward to providing additional information about this study as it proceeds as well as about our ongoing dialogue with the FDA. As previously disclosed, if we achieve positive self-selection data and upon FDA clearance, we would expect to move expeditiously into an actual use trial, akin to a Phase 3 registration trial in clinical development sequencing. "Because STENDRA has the potential of becoming the first ED drug approved OTC and is the only FDA-approved drug in its class that currently enjoys patent protection, we are hopeful that it may significantly expanding Petros' market opportunity, with positive impacts to our growth and profitability. The FDA is in the process of finalizing regulations that create new options for developing safe and effective nonprescription products, and we are carefully navigating those options as we design our studies. As a result, we believe our developmental methodology may ultimately become a model for future programs seeking to switch prescription products to OTC marketing status," concluded Mr. Boctor. About Petros Pharmaceuticals Petros Pharmaceuticals is committed to the goal of becoming a leading innovator in the emerging self-care market driving expanded access to key prescription pharmaceuticals as Over-the-Counter treatment options. Currently, Petros is pursing increased access for its flagship prescription ED therapy, STENDRA, via potential OTC designation. If ultimately approved by the FDA for OTC access, STENDRA may be the first in its class to achieve this marketing status, also establishing company know-how as a proven platform for other prospective prescription therapeutics. About the OTC Pathway The process of switching a prescription medication to over-the-counter (OTC) first involves the design of a Drug Facts Label (DFL) that is well understood by potential consumers. Then data must show that consumers can make an appropriate decision to use or not to use the product based only upon the information on the DFL and their personal medical history. Then consumers must demonstrate that they can properly use the product based upon the information on the DFL. To accomplish these things, the FDA ordinarily requires a consumer-tested OTCDFL. This testing includes conduct of iterative Label Comprehension Studies (LCS) in the general population, Self Selection Studies (SSS) in a population interested in using the product and in specific populations who may be harmed if they use the product, and usually one Actual Use Trial (AUT) demonstrating safe and appropriate use by consumers in a simulated OTC setting. The regulations that FDA is currently finalizing introduced Additional Conditions for Nonprescription Use (ACNU) criteria that enable correct self-selection by consumers and may expand OTC access to medications that formerly could only be available by prescription. An ACNU may be an innovative computerized tool or the additional conditions may use other approaches that support the switch process. About STENDRA® (avanafil) Stendra® (avanafil), originally launched by Auxilium Pharmaceuticals prior to that company's sale to Endo Pharmaceuticals, is an oral phosphodiesterase 5 (PDE5) inhibitor for the treatment of erectile dysfunction. STENDRA is not for use in women or children. It is not known if STENDRA is safe and effective in women or children under 18 years of age. (A 100-mg and 200-mg tablet can be taken as early as ~15 minutes before sexual activity. STENDRA only works with sexual stimulation and should not be taken more than once a day. STENDRA can be taken with or without food; do not drink too much alcohol when taking STENDRA (for example, more than 3 glasses of wine or 3 shots of whiskey) as it can increase chances of side effects. Of people enrolled in clinical trials, 1.4%, 2.0%, and 2.0%, respectively, stopped taking STENDRA (50 mg, 100 mg, or 200 mg) due to side effects compared to 1.7% on placebo. Stendra® was designed and developed expressly for erectile dysfunction. The Company recently undertook a relaunch of Stendra®, generating gross revenues of approximately $30 million in 2019. Petros intends to accelerate the relaunch of Stendra® with a well-funded commercial organization and refocused strategy. STENDRA Important Risk Information STENDRA can cause your blood pressure to drop suddenly to an unsafe level if it is taken with certain other medicines. A sudden drop in blood pressure can cause you to feel dizzy, faint, or have a heart attack or stroke. Do not take STENDRA if you: take medicines called nitrates, which are used to treat chest pain (angina) use street drugs called "poppers," such as amyl nitrate and butyl nitrate take medicines called guanylate cyclase stimulators, which include Adempas® (riociguat), a medicine that treats pulmonary arterial hypertension and chronic thromboembolic pulmonary hypertension are allergic to avanafil or any of the ingredients in STENDRA Stop sexual activity and get medical help right away if you have symptoms such as chest pain, dizziness, or nausea during sex. Sexual activity can put an extra strain on your heart, especially if your heart is already weak from a heart attack or heart disease. Discuss your health with your healthcare provider to ensure you are healthy enough for sex. STENDRA can cause serious side effects. Uncommonly reported side effects include: An erection that will not go away (priapism). If you have an erection that lasts more than 4 hours, get medical help right away. Sudden vision loss in one or both eyes. Sudden vision loss in one or both eyes can be a sign of a serious eye problem called non-arteritic anterior ischemic optic neuropathy (NAION). It is uncertain whether PDE5 inhibitors directly cause vision loss. Stop taking STENDRA and call your healthcare provider right away if you have sudden vision loss in one or both eyes. Sudden hearing decrease or hearing loss. Some people may also have ringing in their ears (tinnitus) or dizziness. Before you take STENDRA, tell your healthcare provider if you: have or have had heart problems such as a heart attack, irregular heartbeat, angina, or heart failure; have had heart surgery within the last 6 months; have had a stroke; have low blood pressure, or high blood pressure that is not controlled; have a deformed penis shape have had an erection that lasted for more than 4 hours; have problems with your blood cells, such as sickle cell anemia, multiple myeloma, or leukemia; have retinitis pigmentosa, a rare genetic (runs in families) eye disease; have ever had severe vision loss, including an eye problem called non-arteritic anterior ischemic optic neuropathy (NAION); have bleeding problems; have or have had stomach ulcers; have liver problems; have kidney problems or are having kidney dialysis; or have any other medical conditions Tell your healthcare provider about all of the medicines you take, including prescription and nonprescription medicines, vitamins, and herbal supplements. STENDRA may affect the way other medicines work, and other medicines may affect the way STENDRA works, which may cause side effects. Especially tell your healthcare provider if you take any of the following: medicines called nitrates medicines called guanylate cyclase stimulators, such as riociguat medicines called HIV protease inhibitors, such as ritonavir (Norvir®), indinavir (Crixivan®), saquinavir (Fortavase® or Invirase®), or atazanavir (Reyataz®) some types of oral antifungal medicines, such as ketoconazole (Nizoral®) and itraconazole (Sporanox®) some types of antibiotics, such as clarithromycin (Biaxin®), telithromycin (Ketek®), or erythromycin medicines called alpha-blockers. These include terazosin (Hytrin®), tamsulosin HCl (Flomax®), doxazosin (Cardura®), prazosin HCl (Minipress®), alfuzosin HCl (UroXatral®), dutasteride and tamsulosin HCl (Jalyn®), or silodosin (Rapaflo®). Alpha-blockers are sometimes prescribed for prostate problems or high blood pressure. In some patients, the use of STENDRA with alpha-blockers can lead to a drop in blood pressure or fainting other medicines that treat high blood pressure other medicines or treatments for ED Do not drink too much alcohol (for example, more than 3 glasses of wine or 3 shots of whiskey) when taking STENDRA, as this can lead to increased chances of headache, dizziness, increased heart rate, or lowered blood pressure. STENDRA does not protect against sexually transmitted diseases, including HIV. The most common side effects of STENDRA are headache, flushing, stuffy or runny nose, sore throat, and back pain. Tell your healthcare provider if you have any side effect that bothers you or does not go away. These are not all of the possible side effects of STENDRA. For more information, ask your healthcare provider or pharmacist. Call your healthcare provider for medical advice about side effects. STENDRA is a prescription medicine used to treat erectile dysfunction (ED). STENDRA is not for use in women or children. It is not known if STENDRA is safe and eﬀective in women or children under 18 years of age. For more information about Stendra, call 844-458-4887. If you would like to report an adverse event or product compliant, please contact us at 844-458-4887. You are encouraged to report adverse events related to prescription drugs to the FDA. Visit or call 1-800-FDA-1088. Please see full Prescribing Information and Patient Information. Cautionary Note Regarding Forward-Looking Statements This press release includes forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. These forward-looking statements are based upon Petros Pharmaceuticals, Inc.'s ("Petros," "we," "our," "us" or the "Company") management's assumptions, expectations, projections, intentions and beliefs about future events. In some cases, predictive, future-tense or forward-looking words such as "intend," "develop," "goal," "plan," "predict", "may," "will," "project," "estimate," "anticipate," "believe," "expect," "continue," "potential," "opportunity," "forecast," "should," "target," "strategy" and similar expressions, whether in the negative or affirmative, that reflect our current views with respect to future events and operational, economic and financial performance are intended to identify forward-looking statements, but are not the exclusive means of identifying such statements. Such forward-looking statements are only predictions, and actual results and the timing of certain events and circumstances may differ materially from those described by the forward-looking statements as a result of risks and uncertainties, Petros' ability to execute on its business strategy, including its plans to develop and commercialize its product candidates; Petros' ability to comply with obligations as a public reporting company; Petros' ability to maintain compliance with the Nasdaq Stock Market's listing standards; risks related to Petros' ability to continue as a going concern; risks related to Petros' history of incurring significant losses; risks related to Petros' dependence on the commercialization of a single product, STENDRA®; and risks related to Petros' ability to obtain regulatory approvals for, or market acceptance of, any of its products or product candidates. Additional factors that could cause actual results to differ materially from the results anticipated in these forward-looking statements are contained in the Company's periodic reports and in other filings that the Company has or may file, with the U.S. Securities and Exchange Commission (the "SEC") under the headings "Risk Factors" and "Management's Discussion and Analysis of Financial Condition and Results of Operations" and elsewhere. The Company cautions readers that the forward-looking statements included in this press release represent our beliefs, expectations, estimates and assumptions only as of the date of hereof and are not intended to give any assurance as to future results. New factors emerge from time to time, and it is not possible for us to predict all of these factors. Further, the Company cannot assess the effect of each such factor on our business or the extent to which any factor, or combination of factors, may cause actual results to be materially different from those contained in any forward-looking statement. Accordingly, you should not unduly rely on any forward-looking statements. The Company undertakes no obligation to update or revise any forward-looking statements contained in this press release, whether as a result of new information, future events, a change in our views or expectations or otherwise, except as required by federal securities laws. Contacts Investors: CORE IR ir@petrospharma.com Media: Jules Abraham CORE IR 917-885-7378 pr@coreir.com SOURCE: Petros Pharmaceuticals, Inc. View source version on accesswire.com:

Phase 2

100 Deals associated with Silodosin

External Link

KEGG	Wiki	ATC	Drug Bank
D01965	Silodosin	G04CA04	DB06207

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
Prostatic Hyperplasia	South Korea	JW PHARMACEUTICAL Corp.	23 Apr 2008

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Urinary Calculi	Phase 2	Japan	Kissei Pharmaceutical Co., Ltd.	27 Feb 2012
Lower Urinary Tract Symptoms	Phase 2	Japan	Kissei Pharmaceutical Co., Ltd.	18 Oct 2010
Calculus, Ureteral	Phase 2	United States	Actavis, Inc.	01 Jun 2010
Kidney Calculi	Phase 2	United States	Actavis, Inc.	01 Jun 2010
Chronic pelvic pain syndrome	Phase 2	United States	Actavis, Inc.	01 Sep 2008
Chronic prostatitis	Phase 2	United States	Actavis, Inc.	01 Sep 2008

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT02369744 (CTgov)	Phase 4	Calculus, Ureteral \| Ureterolithiasis	1	Silodosin (Silodosin)	fmcqxpvgbu(krnftxqcqb) = dewabjxwgn cbkamhcdby (kxlnfkqbme, jgsxcjgome - nphtdamque) View more	-	19 Mar 2020
				Tamsulosin (Tamsulosin)	fmcqxpvgbu(krnftxqcqb) = rszrgbgtlj cbkamhcdby (kxlnfkqbme, ojrhdqhqew - nzvrswmupy) View more
AUA2015	Not Applicable	Prostatic Hyperplasia prostate-specific antigen	98	Silodosin 8 mg and Dutasteride 0.5 mg	rqfuahmnif(lnrrufgkzu) = thbzhgfbee bowowjppwb (mqncadgxvp )	Positive	01 Apr 2015
NCT01144949 (CTgov)	Phase 2	Kidney Calculi \| Calculus, Ureteral	239	silodosin (Silodsosin)	ojxpqfdrwe = bttgkiibsr xfhxyurxnh (ndibprpnwc, szwkaolfnb - aewcwjrswp) View more	-	11 Aug 2014
				placebo (Placebo)	ojxpqfdrwe = flavuaboyi xfhxyurxnh (ndibprpnwc, ehtblgfbfx - eafjgikfdl) View more
MP48-15 (AUA2014)	Not Applicable	-	137	Silodosin 8 mg	dtckeeqcmr(ojkarjulgg) = anejaculation, hypospermia, reduced or absent orgasmic feeling, low sexual desire, and erectile dysfunction were subjectively reported by 48 (48%), 23 (23%), 11 (11%), 6 (6%), 7 (6%), and 10 (%) patients, respectively syxgkwveqs (wupyjeawsq ) View more	-	01 Apr 2014
NCT00793819 (CTgov)	Phase 2	Prostatic Hyperplasia	215	Silodosin (Silodosin 8mg)	iftmsoyyzg(doulsecuns) = rcsubdnpnj vyhemsxobm (anbkutdqap, 1.35) View more	-	09 Mar 2012
				placebo (Placebo)	iftmsoyyzg(doulsecuns) = ywyjensczw vyhemsxobm (anbkutdqap, 1.44) View more
NCT00740779 (CTgov)	Phase 2	Chronic pelvic pain syndrome \| Chronic prostatitis	153	Silodosin 4 mg (Silodosin 4 mg)	hapcpsorcn(pboalnarjl) = heqmrwilnt ivghwqhkiq (rylxiqkumz, 6.29) View more	-	24 Feb 2012
				Silodosin 8 mg (Silodosin 8 mg)	hapcpsorcn(pboalnarjl) = chrcoduang ivghwqhkiq (rylxiqkumz, 5.94) View more
NCT00359905 (Pubmed \| Eur Urol)	Phase 3	Prostatic Hyperplasia \| Lower Urinary Tract Symptoms	1,228	Silodosin 8 mg	xluuvjtiqn(dmqkztshqt) = The most frequent adverse event with silodosin was a reduced or absent ejaculation during orgasm (14%), a reversible effect as a consequence of the potent and selective α(1A)-adrenoreceptor antagonism of the drug. The incidence was higher than that observed with tamsulosin (2%); however, only 1.3% of silodosin-treated patients discontinued treatment due to this adverse event. akgkkvqgiv (szevjglhoc )	-	01 Mar 2011
				Tamsulosin 0.4 mg
NCT00224133 (CTgov)	Phase 3	Prostatic Hyperplasia	661	Silodosin	kaywxgorfi = yztdhdjtsu awngtflbuh (aowzjhdlqw, botiftkplx - vgauouagah) View more	-	27 Apr 2010
NCT00224107 (CTgov)	Phase 3	Prostatic Hyperplasia	461	Silodosin (Silodosin)	awitxhancs(sruflgbjud) = xmnndvenki wkaxdzzhfk (fisbycatnd, 5.38) View more	-	03 Dec 2009
				Placebo (Placebo)	awitxhancs(sruflgbjud) = rkippjjzhu wkaxdzzhfk (fisbycatnd, 4.91) View more
NCT00224120 (CTgov)	Phase 3	Prostatic Hyperplasia	462	Silodosin (Silodosin)	ibigjmxvtk(rkrdmnriyg) = eomczoimhe idgfvpuyes (twsilunbps, 4.88) View more	-	03 Dec 2009
				Placebo (Placebo)	ibigjmxvtk(rkrdmnriyg) = qooqppeacd idgfvpuyes (twsilunbps, 4.92) View more

Translational Medicine

Boost your research with our translational medicine data.

view full example data

Deal

Boost your decision using our deal data.

view full example data

Core Patent

Boost your research with our Core Patent data.

view full example data

Clinical Trial

Identify the latest clinical trials across global registries.

view full example data

Approval

Accelerate your research with the latest regulatory approval information.

view full example data

Regulation

Understand key drug designations in just a few clicks with Synapse.

view full example data

AI Agents Built for Biopharma Breakthroughs

Accelerate discovery. Empower decisions. Transform outcomes.

Get started for free today!

Accelerate Strategic R&D decision making with Synapse, PatSnap’s AI-powered Connected Innovation Intelligence Platform Built for Life Sciences Professionals.

Start your data trial now!

Synapse data is also accessible to external entities via APIs or data packages. Empower better decisions with the latest in pharmaceutical intelligence.

Bio

Bio Sequences Search & Analysis

Chemical

Chemical Structures Search & Analysis

Silodosin

Overview

Basic Info

Structure/Sequence

Related

External Link

R&D Status

Clinical Result

Translational Medicine

Deal

Core Patent

Clinical Trial

Approval

Regulation