Yesterday, the last study participant in the MAD study completed his final clinic visit doing a safety follow-up. We are thereby done with the clinical part of our phase 1 study and confirm that the reporting from this part of the study will be published at the end of April. This will be followed by an in-depth summary of results for the entire phase 1 study later in the second quarter. Read more: https://lnkd.in/d3e8uUNh #clinicaltrials #pharma #pharmaceutical #drugdevelopment #sexualdysfunctions #erectiledysfunction #prematureejaculation #lifescience #kliniskastudier #läkemedelsutveckling #sexuelladysfunktioner #erektionssvikt #tidigutlösning
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3 countries, 6 clinics, 140 patients. We have just got the authorization to start our phase 2a study! Now, we set out to confirm the efficacy signal detected in the phase 1-study together with Clinical Trial Consultants, who were also the responsible CRO in phase 1. Read all about the study and the chosen countries here: https://lnkd.in/dP8MnQEc #CTC #clinicaltrialconsultants #pharma #pharmaceutical #drugdevelopent #sexualdysfunctions #erectiledysfunction #prematureejaculation #lifescience #kliniskastudier #läkemedelsutveckling #sexuelladysfunktioner #erektionssvikt #tidigutlösning
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🚀 Exciting Milestone Reached: Phase 2a Study for LIB-01 Begins! 🚀 We’re thrilled to share that Dicot Pharma AB has received regulatory approval to initiate the Phase 2a clinical trial of LIB-01, a promising candidate for treating erectile dysfunction. This placebo-controlled study will take place across Sweden, Denmark, and here in the Netherlands, with CTC Netherlands as one of the six clinical sites involved. The trial will evaluate LIB-01's efficacy in 140 patients over an eight-week period, with participant screening set to start soon. We’re proud to contribute to this study alongside the dedicated team at CTC Clinical Trial Consultants AB and look forward to supporting Dicot Pharma's journey toward advancing treatment options for erectile dysfunction. This is a major step toward transforming patient outcomes in this space, and we’re excited to see the impact LIB-01 could have on global healthcare! #CTCNetherlands #DicotPharma #LIB01 #ClinicalTrials #Biotech #HealthcareInnovation #ErectileDysfunction
3 countries, 6 clinics, 140 patients. We have just got the authorization to start our phase 2a study! Now, we set out to confirm the efficacy signal detected in the phase 1-study together with Clinical Trial Consultants, who were also the responsible CRO in phase 1. Read all about the study and the chosen countries here: https://lnkd.in/dP8MnQEc #CTC #clinicaltrialconsultants #pharma #pharmaceutical #drugdevelopent #sexualdysfunctions #erectiledysfunction #prematureejaculation #lifescience #kliniskastudier #läkemedelsutveckling #sexuelladysfunktioner #erektionssvikt #tidigutlösning
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🚀 Exciting Milestone Reached: Phase 2a Study for LIB-01 Begins! 🚀 We’re thrilled to share that Dicot Pharma AB has received regulatory approval to initiate the Phase 2a clinical trial of LIB-01, a promising candidate for treating erectile dysfunction. This placebo-controlled study will take place across Sweden, Denmark, and here in the Netherlands, with CTC Netherlands as one of the six clinical sites involved. The trial will evaluate LIB-01's efficacy in 140 patients over an eight-week period, with participant screening set to start soon. We’re proud to contribute to this study alongside the dedicated team at CTC Clinical Trial Consultants AB and look forward to supporting Dicot Pharma's journey toward advancing treatment options for erectile dysfunction. This is a major step toward transforming patient outcomes in this space, and we’re excited to see the impact LIB-01 could have on global healthcare! hashtag #CTCNetherlands hashtag #DicotPharma hashtag #LIB01 hashtag #ClinicalTrials hashtag #Biotech hashtag #HealthcareInnovation hashtag #ErectileDysfunction
3 countries, 6 clinics, 140 patients. We have just got the authorization to start our phase 2a study! Now, we set out to confirm the efficacy signal detected in the phase 1-study together with Clinical Trial Consultants, who were also the responsible CRO in phase 1. Read all about the study and the chosen countries here: https://lnkd.in/dP8MnQEc #CTC #clinicaltrialconsultants #pharma #pharmaceutical #drugdevelopent #sexualdysfunctions #erectiledysfunction #prematureejaculation #lifescience #kliniskastudier #läkemedelsutveckling #sexuelladysfunktioner #erektionssvikt #tidigutlösning
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Now we’re underway! The first participants have been dosed in our Phase 2a study. Among the six clinics across Sweden, Denmark, and the Netherlands, it was Stockholm and Gothenburg who were the first ones out. We are now entering an intensive period of ongoing recruitment, and the ones participating will receive doses for three consecutive days and then be monitored during eight weeks to evaluate efficacy and safety. #clinicaltrials #pharma #pharmaceutical #drugdevelopment #sexualdysfunctions #erectiledysfunction #prematureejaculation #lifescience #kliniskastudier #läkemedelsutveckling #sexuelladysfunktioner #erektionssvikt #tidigutlösning
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We have just completed the recruitment to the final part of our phase 1 study and we are good to go. Results are expected in quarter two. "The fact that the last MAD participant has been enrolled is another important milestone we can tick off. Our collaboration with the CRO partner CTC is exemplary, greatly assisting us in constantly being on schedule", Elin comments. #clinicaltrials #pharma #pharmaceutical #drugdevelopment #sexualdysfunctions #erectiledysfunction #prematureejaculation #lifescience #kliniskastudier #läkemedelsutveckling #sexuelladysfunktioner #erektionssvikt #tidigutlösning
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💊 The 9th Annual MarketsandMarkets™️ High Potency Medicines Conference comes to a close today in Milan. It was two days of meetings and conferences where we had the chance to 𝗽𝗿𝗲𝘀𝗲𝗻𝘁 𝗼𝘂𝗿 𝗰𝗼𝗻𝘁𝗮𝗶𝗻𝗺𝗲𝗻𝘁 𝘀𝗼𝗹𝘂𝘁𝗶𝗼𝗻𝘀. 🤝 We had many interested parties in both our technologies and the solutions proposed by our partner ChargePoint Technology, who with Christian Dunne, also had the opportunity to present our collaboration in a talk on a 𝘃𝗮𝗹𝘃𝗲 𝘀𝘁𝗲𝗿𝗶𝗹𝗶𝘇𝗮𝘁𝗶𝗼𝗻. ⬇️Check out our video to see everything that happened and keep following us for more updates! #hpapi #HighPotentMedicines #pharmaceutical #containmentsolutions #pharmaindustry #pharma #drugdevelopment #isolators #ChargePointTechnology
HPAPI Conference - Milan
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The US is an utterly important market for us. We have now started interacting with FDA and just completed a pre-IND meeting receiving positive feedback on our development program for LIB-01. This is an important step towards including US study centers in future clinical studies. An early interaction with FDA is considered valuable to reach a consensus and ultimately secure market approval in the United States. "The FDA response shows that we are on the right track in our efforts to create a best-in-class drug in erectile dysfunction. It is also a quality mark for our development work that adds weight in discussions with potential pharmaceutical partners", comments Elin. Read the press release here: https://lnkd.in/dx7z5kAF #dicotnytt #pharma #pharmaceutical #drugdevelopment #sexualdysfunctions #erectiledysfunction #prematureejaculation #lifescience #kliniskastudier #läkemedelsutveckling #sexuelladysfunktioner #erektionssvikt #tidigutlösning
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Struggling to enhance #patient #diversity in your studies? 🌍 Discover how we successfully implemented #outreach strategies to boost diversity in a complex Systemic Lupus Erythematosus (#SLE) study. Learn from our innovative approach and drive #OptimizationSuccess in your #clinicaltrials. 👉 https://bit.ly/3WALsr5 #ClinicalResearch #PatientRecruitment #Innovation #PharmaIndustry #Pharma #Pharmaceutical #PatientAccess #ClinicalTrialsSuccess
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From our just released DICOTnytt: the name change, the other indications, and how a record was broken at the Annual General Meeting. Click here to read the June edition of our bi-monthly newsletter (in Swedish): https://lnkd.in/d9qa94-P #dicotnytt #pharma #pharmaceutical #drugdevelopment #sexualdysfunctions #erectiledysfunction #prematureejaculation #lifescience #kliniskastudier #läkemedelsutveckling #sexuelladysfunktioner #erektionssvikt #tidigutlösning
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💉Conventionally, the integrity of container closure systems (CCS) is determined by testing the drug products for sterility and/or container closure integrity (CCI). 📄 However, BioPhorum's Fill Finish members have recently collaborated to create what is, to our knowledge, the first publication of an industry-wide view of a holistic approach to CCI for a parenteral product. This science and risk-based approach in biopharmaceutical product development and manufacture is : ✅in line with current regulations ✅more robust ✅aims to build quality into the design and processes rather than relying solely on testing or inspecting the finished product. Download here 👉 https://bit.ly/3IpU1QU #BioPhorum #FillFinish #ContainerClosureIntegrity #BioPharma #BioPharmaceuticals #Holistic Gillian Holmes Martin Mc Ilkenny Scarlett Nunn Jonathan Cox
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8moGreat to read! We’ll done everyone involved!