Clinical Trials
271
195 active
Approvals
48
Total approvals
Agencies
4
Regulatory bodies
Founded
1946
Active, not recruiting
194
71.6%
Completed
50
18.4%
Not yet recruiting
1
0.4%
Recruiting
4
1.5%
Terminated
16
5.9%
Withdrawn
4
1.5%
- Medincell, a clinical- and commercial-stage biopharmaceutical company developing long-acting injectable treatments, has appointed Edna Venneker, MD, as its new Chief Medical Officer. - Venneker most recently served as Head of Development and Senior Vice President at Grünenthal, bringing deep expertise in neuroscience and CNS disorders. - Her experience spans small molecules, biologics, vaccines, and advanced therapies, with direct interactions with the FDA, EMA, and PMDA across the drug development lifecycle. - The appointment aims to strengthen Medincell's ability to select promising opportunities, reduce development risk, and advance its next generation of long-acting medicines.
- Grünenthal has joined the Cluster for Nucleic Acid Therapeutics Munich (CNATM) to strengthen its oligonucleotide drug discovery capabilities in pain and neurological indications. - The company has built internal expertise in antisense oligonucleotides (ASOs) and siRNA modalities, with a focus on targeted delivery to neuronal cells and tissues. - Key objectives include improving understanding of oligonucleotide design, delivery, and cellular activity for conditions such as pain, epilepsy, and neurodegenerative disorders. - The CNATM network includes Ludwig-Maximilians-Universität Munich, Technical University of Munich, Helmholtz Centre Munich, and 14 biotech and industry partners.
- Grünenthal successfully completed a Phase I trial of its proprietary NOP agonist in 113 healthy participants, demonstrating safety and tolerability with no dose-dependent adverse event pattern. - The compound features a unique mechanism of action through selective nociceptin receptor activation and showed no opioid-like side effects such as somnolence, constipation, or respiratory depression. - Grünenthal plans to initiate a Phase II trial later this year enrolling 400 U.S. patients undergoing bunionectomy, with results expected in the second half of 2027. - If successful, the NOP agonist could represent a first-in-class, non-opioid therapy for acute and chronic pain with robust analgesia and no abuse liability potential.
- Grünenthal has enrolled the first healthy volunteers in a Phase I trial of its proprietary voltage-gated sodium channel (NaV) 1.8 inhibitor, targeting non-opioid pain therapy. - The 70-participant trial comprises Single and Multiple Ascending Dose studies to evaluate safety, tolerability, and pharmacokinetics, with results expected in the second half of 2026. - The NaV 1.8 channel represents a clinically validated pain target that plays a significant role in triggering excitatory signals in nociceptive neurons. - This development follows the FDA approval of the first NaV 1.8-targeting medicine last year, with Grünenthal aiming to provide more comprehensive channel blocking.
- Averitas Pharma has finished enrolling 410 patients in its Phase III AV001 trial assessing QUTENZA for post-surgical neuropathic pain (PSNP). - The randomized, double-blind study will evaluate QUTENZA's safety, efficacy, and tolerability over 42 weeks, with topline results expected in Q4 2025. - The primary endpoint is the decrease in average pain intensity at 12 weeks compared to baseline, potentially expanding QUTENZA's US indication. - If successful, Averitas Pharma plans to submit a supplemental new drug application (sNDA) in 2026, addressing an unmet need for non-opioid PSNP treatment.
- Averitas Pharma has finished recruiting 410 patients for its Phase III AV001 trial assessing QUTENZA for post-surgical neuropathic pain (PSNP). - The randomized, double-blind study will evaluate QUTENZA's safety, efficacy, and tolerability over 42 weeks, with topline results expected in Q4 2025. - The primary endpoint is the reduction in average pain intensity at week 12 compared to baseline, potentially expanding QUTENZA's US indication. - Averitas plans to submit a supplemental New Drug Application (sNDA) in 2026 if the trial demonstrates positive outcomes for PSNP treatment.
- Grünenthal and Averitas Pharma have completed recruitment for a Phase III trial (AV001) evaluating Qutenza® (capsaicin) 8% topical system for post-surgical neuropathic pain (PSNP). - The randomized, double-blind trial includes 410 patients and assesses the efficacy, safety, and tolerability of Qutenza® over 42 weeks, with topline results expected in Q4 2025. - The primary endpoint is the reduction in average pain intensity after 12 weeks compared to baseline, with secondary endpoints including long-term pain reduction and quality of life improvements. - Averitas Pharma aims to submit a supplemental new drug application (sNDA) to the FDA in 2026, assuming positive data, to expand Qutenza's label to include PSNP.
- Grunenthal and Averitas Pharma completed enrollment for the Phase III clinical trial AV001, evaluating Qutenza in post-surgical neuropathic pain (PSNP). - The trial aims to assess the efficacy, safety, and tolerability of Qutenza (capsaicin) 8% topical system for PSNP, a condition affecting over 3 million people in the U.S. annually. - Qutenza is currently approved for postherpetic neuralgia and diabetic peripheral neuropathy; a successful trial could lead to a U.S. label extension in 2026. - The randomized, double-blind trial includes 410 patients, with topline results expected in Q4 2025, potentially offering a non-opioid option for PSNP.
- Grünenthal and Averitas Pharma have completed recruitment for the Phase III clinical trial AV001, evaluating Qutenza in post-surgical neuropathic pain (PSNP). - The trial aims to assess the efficacy, safety, and tolerability of Qutenza (capsaicin) 8% topical system in patients with moderate to severe PSNP. - Topline results from the AV001 trial are expected in Q4 2025, with a potential sNDA submission to the FDA for label extension in 2026. - PSNP affects approximately 10% of surgical patients, and Qutenza could provide a non-opioid treatment option for this underserved population.
- Grünenthal and Averitas Pharma completed enrollment for the Phase III AV001 trial evaluating Qutenza (capsaicin 8% topical system) in post-surgical neuropathic pain (PSNP). - The AV001 trial is a randomized, double-blind study involving 410 patients suffering from moderate to severe PSNP for at least six months. - Topline results from the AV001 trial are expected in Q4 2025, with a potential supplemental new drug application (sNDA) submission to the FDA planned for 2026. - Qutenza is currently approved in the U.S. for postherpetic neuralgia and diabetic peripheral neuropathy; this trial aims to expand its label to include PSNP.
