Drugs - Clinical Trial Results
Clinical trial news from Drugs.com. Comprehensive, up-to-date drug news for consumers and healthcare professionals.
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Bristol Myers Squibb Announces Topline Results from Phase 3 ARISE Trial Evaluating Cobenfy (xanomeline and trospium chloride) as an Adjunctive Treatment to Atypical Antipsychotics in Adults with Schizophrenia
PRINCETON, N.J.--(BUSINESS WIRE) Apr 22, 2025 -- Bristol Myers Squibb (NYSE: BMY) today announced topline results from the Phase 3 ARISE trial evaluating the efficacy and safety of Cobenfy (xanomeline and trospium chloride) as an adjunctive... -
Orforglipron Demonstrated Statistically Significant Efficacy Results and a Safety Profile Consistent with Injectable GLP-1 Medicines in Successful Phase 3 Trial
INDIANAPOLIS, April 17, 2025 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) today announced positive topline Phase 3 results from ACHIEVE-1, evaluating the safety and efficacy of orforglipron compared to placebo in adults with type 2 diabetes and... -
BlueRock Therapeutics Announces Publication in Nature of 18-Month Data from Phase 1 Clinical Trial for Bemdaneprocel, an Investigational Cell Therapy for Parkinson’s Disease
Cambridge MA, USA, April 16, 2025 – BlueRock Therapeutics LP, a clinical-stage cell therapy company and wholly owned subsidiary of Bayer AG, today announced the publication of the 18-month data from its Phase 1 exPDite clinical trial for... -
Repurposing Blood Pressure Drug Reserpine May Prevent Vision Loss in Inherited Blinding Diseases
Tuesday, April 15, 2025 -- New studies in rats suggest the drug reserpine, approved in 1955 for high blood pressure, might treat the blinding disease retinitis pigmentosa. No therapy exists for this rare inherited disease, which starts affecting... -
Precision BioSciences Receives U.S. FDA Fast Track Designation for PBGENE-HBV, a First-In-Class Gene Editing Therapy Designed to Eliminate the Root Cause of Chronic Hepatitis B
DURHAM, N.C.--(BUSINESS WIRE)--Apr. 15, 2025-- Precision BioSciences, Inc. (Nasdaq: DTIL), a clinical stage gene editing company utilizing its novel proprietary ARCUS® platform to develop in vivo gene editing therapies for diseases with high... -
Click Therapeutics Announces FDA Marketing Authorization for CT-132, the First Prescription Digital Therapeutic for the Preventive Treatment of Episodic Migraine in the United States
NEW YORK, N.Y. (April 15, 2025) – Click Therapeutics, Inc., (“Click”) a leader in prescription medical treatments as both prescription digital therapeutics and software-enhanced drug™ therapies, has obtained FDA marketing... -
Bristol Myers Squibb Provides Update on Camzyos Phase 3 ODYSSEY-HCM Trial
PRINCETON, N.J.-- April 14, 2025 (BUSINESS WIRE) -- Bristol Myers Squibb (NYSE: BMY) today announced the Phase 3 ODYSSEY-HCM trial evaluating Camzyos (mavacamten) for the treatment of adult patients with symptomatic New York Heart Association... -
Ironwood Pharmaceuticals Provides Clinical and Regulatory Update on Apraglutide
BOSTON--(BUSINESS WIRE) April 14, 2025 -- Ironwood Pharmaceuticals, Inc. (Nasdaq: IRWD), a biotechnology company developing and commercializing life-changing therapies for people living with gastrointestinal (GI) and rare diseases, today announced... -
Pfizer Discontinues Development of Oral GLP-1 Receptor Agonist Danuglipron
NEW YORK--(BUSINESS WIRE) April 14, 2025 -- Pfizer Inc. (NYSE: PFE) today announced the decision to discontinue development of danuglipron (PF-06882961), an oral glucagon-like peptide-1 (GLP-1) receptor agonist, which was being investigated for... -
Novo Nordisk Warns Consumers About Counterfeit Ozempic (semaglutide) Injection 1 mg in the US
PLAINSBORO, N.J., April 14, 2025 /PRNewswire/ -- Novo Nordisk has become aware of several hundred units of Ozempic (semaglutide) injection 1 mg distributed outside the Novo Nordisk authorized supply chain in the US. The US Food and Drug... -
Cellenkos Announces US FDA Orphan Drug Designation Granted to CK0801 (Allogeneic Cord Blood derived T regulatory Cell Product) for Treatment of Aplastic Anemia
HOUSTON, April 14, 2025 /PRNewswire/ -- Cellenkos Inc., a clinical-stage biotechnology company focused on developing allogeneic, off-the-shelf, T regulatory (Treg) cell therapies for inflammatory disease areas of high unmet needs and autoimmune... -
Verve Therapeutics Receives U.S. FDA Fast Track Designation for VERVE-102, an In Vivo Base Editing Medicine Targeting PCSK9
BOSTON, April 11, 2025 (GLOBE NEWSWIRE) -- Verve Therapeutics, a clinical-stage company developing a new class of genetic medicines for cardiovascular disease, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track... -
FDA Announces Plan to Phase Out Animal Testing Requirement for Monoclonal Antibodies and Other Drugs
April 10, 2025 -- Today, the U.S. Food and Drug Administration is taking a groundbreaking step to advance public health by replacing animal testing in the development of monoclonal antibody therapies and other drugs with more effective... -
Tolebrutinib Phase 3 Data Published in NEJM Demonstrate Benefit on Disability Progression in Multiple Sclerosis
Paris, April 8, 2025. The New England Journal of Medicine (NEJM) published positive results from the HERCULES phase 3 study demonstrating that tolebrutinib delayed disability progression in people with non-relapsing secondary progressive multiple... -
Icotrokinra Results Show 75% of Adolescents with Plaque Psoriasis Achieved Completely Clear Skin and Demonstrate Favorable Safety Profile in a Once Daily Pill
SPRING HOUSE, Pa. (April 10, 2025) – Johnson & Johnson (NYSE: JNJ) today announced new icotrokinra (JNJ-2113) data from a subgroup analysis of ICONIC-LEADa, the first ever Phase 3 registrational study in moderate-to-severe plaque... -
Allogene Granted Three U.S. FDA Fast Track Designations (FTD) for ALLO-329, a Next-Generation Dual-Targeted CD19/CD70 Allogeneic CAR T, for the Treatment of Lupus, Myositis and Scleroderma
SOUTH SAN FRANCISCO, Calif., April 07, 2025 (GLOBE NEWSWIRE) -- Allogene Therapeutics, Inc. (Nasdaq: ALLO), a clinical-stage biotechnology company pioneering the development of allogeneic CAR T (AlloCAR T™) products for cancer and autoimmune... -
Theravance Biopharma Presents Two New Ampreloxetine Analyses
DUBLIN, April 7, 2025 /PRNewswire/ -- Theravance Biopharma, Inc. ("Theravance Biopharma" or the "Company") (NASDAQ: TBPH) today announced new analyses from its previous Phase 3 program evaluating ampreloxetine, an investigational medicine for the... -
Genentech and Roche Present Novel Therapeutic and Diagnostic Advancements in Alzheimer’s at AD/PD 2025
South San Francisco, CA -- April 3, 2025 -- Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY) announced today that new data were presented at the AD/PD 2025 International Conference on Alzheimer’s and Parkinson’s... -
Rilzabrutinib Granted Orphan Drug Designation in the US for Two Rare Diseases with No Approved Medicines
Paris, April 3, 2025. The US Food and Drug Administration (FDA) has granted orphan drug designation to rilzabrutinib, an investigational, novel, advanced, oral, reversible Bruton’s tyrosine kinase (BTK) inhibitor, for two rare diseases, warm... -
BeiGene Provides Update on the Ociperlimab (BGB-A1217) Clinical Development Program
SAN CARLOS, Calif.--(BUSINESS WIRE) April 3, 2025 -- BeiGene, Ltd. (NASDAQ: ONC; HKEX: 06160; SSE: 688235), a global oncology company that intends to change its name to BeOne Medicines Ltd., today announced the discontinuation of its clinical... -
Vividion Therapeutics Doses First Patient in Phase I Study of RAS-PI3Kα Inhibitor VVD-159642 for Treatment of Advanced Solid Tumors
San Diego, CA, USA, Berlin, Germany, April 3, 2025 – Vividion Therapeutics, Inc. (Vividion) today announced that the first patient has been dosed in a Phase I clinical trial evaluating VVD-159642, an investigational oral inhibitor designed to... -
AI Screening for Opioid Use Disorder Associated with Fewer Hospital Readmissions
April 3, 2025 -- An artificial intelligence (AI)-driven screening tool, developed by a National Institutes of Health (NIH)-funded research team, successfully identified hospitalized adults at risk for opioid use disorder and recommended referral to... -
Biogen’s Investigational Tau-Targeting Therapy BIIB080 Receives FDA Fast Track Designation for the Treatment of Alzheimer’s Disease
CAMBRIDGE, Mass., April 02, 2025 (GLOBE NEWSWIRE) -- Biogen Inc. (Nasdaq: BIIB) today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to BIIB080, an investigational antisense oligonucleotide (ASO)... -
Combination Immunotherapy Shrank a Variety of Metastatic Gastrointestinal Cancers
April 1, 2025 -- A new form of tumor infiltrating lymphocyte (TIL) therapy, a form of personalized cancer immunotherapy, dramatically improved the treatment’s effectiveness in patients with metastatic gastrointestinal cancers, according to... -
Primary Endpoint Met in Corcept’s Pivotal Phase 3 ROSELLA Trial of Relacorilant in Patients with Platinum-Resistant Ovarian Cancer
REDWOOD CITY, Calif.--(BUSINESS WIRE)--Mar. 31, 2025-- Corcept Therapeutics Incorporated (NASDAQ: CORT), a commercial-stage company engaged in the discovery and development of medications to treat severe endocrinologic, oncologic, metabolic and... -
AZD0780, a Novel Oral PCSK9 Inhibitor, Demonstrated Significant LDL Cholesterol (LDL-C) Reduction in PURSUIT Phase IIb Trial
31 March 2025 -- Positive results from the PURSUIT Phase IIb trial for AstraZeneca’s AZD0780 demonstrated a statistically significant low-density lipoprotein cholesterol (LDL-C) reduction when administered on top of standard-of-care statin... -
Lilly's Lepodisiran Reduced Levels of Genetically Inherited Heart Disease Risk Factor, Lipoprotein(a), by Nearly 94% from Baseline at the Highest Tested Dose in Adults with Elevated Levels
INDIANAPOLIS, March 30, 2025 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) today announced positive Phase 2 results for lepodisiran, an investigational small interfering RNA (siRNA) therapy designed to lower the production of lipoprotein(a)... -
Mineralys Therapeutics Announces Late-Breaking Data from Advance-HTN Pivotal Trial of Lorundrostat in Uncontrolled and Resistant Hypertension
RADNOR, Pa., March 29, 2025 (GLOBE NEWSWIRE) -- Mineralys Therapeutics, Inc. (Nasdaq: MLYS), a clinical-stage biopharmaceutical company focused on developing medicines to target hypertension, chronic kidney disease (CKD), obstructive sleep apnea... -
Merck’s Investigational Subcutaneous Pembrolizumab With Berahyaluronidase Alfa Demonstrates Noninferior Pharmacokinetics Compared to Intravenous (IV) Keytruda® (pembrolizumab) in Pivotal 3475A-D77 Trial
RAHWAY, N.J.--(BUSINESS WIRE) March 27, 2025 -- Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced the first data presentation from the pivotal 3475A-D77 Phase 3 trial, evaluating the subcutaneous... -
Chlamydia Vaccine Candidate Granted Fast Track Designation by the US FDA
Paris, March 26, 2025. The US Food and Drug Administration has granted fast track designation to Sanofi’s mRNA vaccine candidate for the prevention of chlamydia infection. The decision was based on the potential of the vaccine candidate to... -
Palatin’s Oral MC4R Agonist PL7737 Receives FDA Orphan Drug Designation for Obesity Due to Leptin Receptor Deficiency
CRANBURY, N.J., March 25, 2025 /PRNewswire/ — Palatin Technologies, Inc. (NYSE American: PTN), a biopharmaceutical company developing first-in-class medicines based on molecules that modulate the activity of the melanocortin receptor system... -
The United Laboratories and Novo Nordisk Announce Exclusive License Agreement for UBT251, a GLP-1/GIP/Glucagon Triple Receptor Agonist
Guangdong, China and Bagsværd, Denmark, 24 March 2025 –The United Laboratories International Holdings Limited (TUL) and Novo Nordisk A/S (Novo Nordisk) today announced that Novo Nordisk and TUL’s wholly-owned subsidiary The United... -
NIH Researchers Develop Eye Drops That Slow Vision Loss in Animals
Researchers at the National Institutes of Health (NIH) have developed eye drops that extend vision in animal models of a group of inherited diseases that lead to progressive vision loss in humans, known as retinitis pigmentosa. The eye drops contain... -
Omeros Corporation Provides Update of Ongoing Zaltenibart Phase 3 PNH Clinical Trial Program
SEATTLE--(BUSINESS WIRE)--Mar. 21, 2025-- Omeros Corporation (Nasdaq: OMER) today reported that clinical trial site activation for enrollment is underway for the company’s Phase 3 program evaluating zaltenibart in paroxysmal nocturnal... -
New Data on Investigational Therapy Doxecitine and Doxribtimine for Thymidine Kinase 2 Deficiency Presented at Muscular Dystrophy Association (MDA) 2025 Conference
Brussels (Belgium) 19 March 2025 – UCB, a global biopharmaceutical company, today announced positive data from studies involving its investigational pyrimidine nucleoside therapy, doxecitine (dC) and doxribtimine (dT), in people living with... -
Immunovant Announces Positive Results for Batoclimab Myasthenia Gravis (MG) and Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) Studies
NEW YORK, March 19, 2025 (GLOBE NEWSWIRE) -- Immunovant, Inc. (Nasdaq: IMVT), a clinical-stage immunology company dedicated to enabling normal lives for people with autoimmune diseases, today reported topline results from its Phase 3 study of... -
Henlius Receives Orphan-Drug Designation for HLX22 (Innovative anti-HER2 mAb) in the U.S. for Gastric Cancer
Shanghai, China, March 19, 2025 - Shanghai Henlius Biotech, Inc. (2696.HK) announced that the US Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) for HLX22, the company's innovative anti-HER2 monoclonal antibody (mAb) for... -
Azer-cel Granted FDA Fast Track Designation in Blood Cancer DLBCL
SYDNEY, Australia, 19 March 2025: Imugene Limited (ASX:IMU), a clinical-stage immuno-oncology company, is pleased to announce that the US Food and Drug Administration (FDA) has granted Fast Track Designation to its allogeneic CAR T-cell therapy... -
FDA Approved Compassionate Use Treatment with Namodenoson in a Pancreatic Cancer Patient
Ramat Gan, Israel, March 18, 2025 (GLOBE NEWSWIRE) -- Can-Fite BioPharma Ltd. (NYSE American: CANF) (TASE: CANF), a biotechnology company developing a pipeline of proprietary small molecule drugs targeting oncological and inflammatory diseases... -
Sarepta Therapeutics Shares Safety Update on Elevidys
CAMBRIDGE, Mass., March 18, 2025 -- Sarepta Therapeutics, Inc. (NASDAQ:SRPT), the leader in precision genetic medicine for rare diseases, shared the following safety update related to Elevidys (delandistrogene moxeparvovec-rokl), the only approved...
