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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First Clinical Data for Gilead’s Investigational Once-Yearly Lenacapavir for HIV Prevention Presented at CROI 2025 and Published in The Lancet
FOSTER CITY, Calif.--(BUSINESS WIRE) March 11, 2025 -- Gilead Sciences, Inc. (Nasdaq: GILD) today presented the first data from its ongoing Phase 1 study investigating two novel, once-yearly formulations of lenacapavir, the company’s... -
Biogen Initiates Phase 3 Study of Felzartamab for the Treatment of Late Antibody-Mediated Rejection (AMR) in Kidney Transplant Patients
CAMBRIDGE, Mass., March 11, 2025 (GLOBE NEWSWIRE) -- Biogen Inc. (Nasdaq: BIIB) – announced the initiation of dosing in the global clinical study, TRANSCEND. The Phase 3 study will evaluate the efficacy and safety of the investigational drug... -
CagriSema Demonstrates Superior Weight Loss in Adults with Obesity or Overweight and Type 2 Diabetes in the REDEFINE 2 Trial
Bagsværd, Denmark, 10 March 2025 – Today, Novo Nordisk announced headline results from REDEFINE 2, a phase 3 trial in the global REDEFINE programme. REDEFINE 2 is a 68-week efficacy and safety trial investigating once-weekly subcutaneous... -
Icotrokinra Meets Primary Endpoint of Clinical Response in Ulcerative Colitis Study and Shows Potential to Transform the Treatment Paradigm for Patients
SPRING HOUSE, Pa. (March 10, 2025) – Johnson & Johnson (NYSE: JNJ) today announced positive topline results from ANTHEM-UC, a Phase 2b study of icotrokinra (JNJ-2113), the first investigational targeted oral peptide that selectively blocks... -
Q32 Bio Presents Results from SIGNAL-AA Part A Clinical Trial Evaluating Bempikibart in Patients with Alopecia Areata
WALTHAM, Mass., March 8, 2025 /PRNewswire/ -- Q32 Bio Inc. (Nasdaq: QTTB) ("Q32 Bio"), a clinical stage biotechnology company focused on developing biologic therapeutics to restore immune homeostasis, today announced additional results from Part A... -
Icotrokinra Results Show Potential to Set a New Standard of Treatment in Plaque Psoriasis
SPRING HOUSE, Pa. (March 8, 2025) – Johnson & Johnson (NYSE: JNJ) today announced new icotrokinra (JNJ-2113) data from its comprehensive Phase 3 clinical program and the start of the first-ever head-to-head study in plaque psoriasis (PsO)... -
Amgen and Kyowa Kirin Provide Top-Line Results from Rocatinlimab Phase 3 Ignite Study in Adults with Moderate to Severe Atopic Dermatitis
THOUSAND OAKS, Calif., and TOKYO, March 8, 2025 /PRNewswire/ -- Amgen (NASDAQ: AMGN) and Kyowa Kirin Co., Ltd. (Kyowa Kirin, TSE: 4151) today announced new results from the ongoing ROCKET Phase 3 clinical trial program evaluating rocatinlimab, an... -
PDS Biotech Initiates VERSATILE-003 Phase 3 Clinical Trial Evaluating Versamune HPV in HPV16-Positive Head and Neck Cancer
PRINCETON, N.J., March 07, 2025 (GLOBE NEWSWIRE) -- PDS Biotechnology Corporation (Nasdaq: PDSB) (“PDS Biotech” or the “Company”), a late-stage immunotherapy company focused on transforming how the immune system targets and... -
Plus Therapeutics Granted U.S. FDA Orphan Drug Designation for Rhenium (186Re) Obisbemeda for the Treatment of Leptomeningeal Metastases in Patients with Lung Cancer
HOUSTON, March 06, 2025 (GLOBE NEWSWIRE) -- Plus Therapeutics, Inc. (Nasdaq: PSTV) (the “Company” or “Plus Therapeutics”), a clinical-stage pharmaceutical company developing targeted radiotherapeutics with advanced platform... -
Tris Pharma Announces Positive Results from ALLEVIATE-2 Phase 3 Pivotal Trial for Cebranopadol, an Investigational First-in-Class Oral Dual-NMR Agonist, for the Treatment of Moderate-to-Severe Acute Pain
MONMOUTH JUNCTION, NJ, March 6, 2025 – Business Wire – Tris Pharma, Inc. (Tris), a commercial-stage biopharmaceutical company, today announced positive topline results from its ALLEVIATE-2 Phase 3 pivotal clinical trial evaluating... -
Tenax Therapeutics Expands Phase 3 LEVEL Program, Advancing Two TNX-103 (Oral Levosimendan) Registrational Studies for the Treatment of PH-HFpEF
CHAPEL HILL, N.C., March 05, 2025 (GLOBE NEWSWIRE) -- Tenax Therapeutics, Inc. (Nasdaq: TENX) (“Tenax Therapeutics” or the “Company”), a Phase 3, development-stage pharmaceutical company using clinical insights to develop... -
Novo Nordisk Introduces NovoCare® Pharmacy, Lowering Cost of All Doses of FDA-Approved Wegovy® (semaglutide) to $499 per Month
PLAINSBORO, N.J., March 5, 2025 /PRNewswire/ -- As part of its ongoing efforts to ensure patients who need Wegovy® (semaglutide) injection 0.25 mg, 0.5 mg, 1 mg, 1.7 mg, and 2.4 mg can access it, Novo Nordisk launched NovoCare® Pharmacy, a... -
NIH-Funded Research Team Engineers New Drug Targeting Pain Sensation Pathway
March 5, 2025 -- A research team funded by the National Institutes of Health (NIH) has developed a medication that shows promise in treating acute and chronic pain. The drug, known as VIP36, targets the body’s cannabinoid receptor type 1... -
Cingulate Reports Safety Results from Final Phase 3 Trials for Lead ADHD Asset CTx-1301
KANSAS CITY, Kan., March 04, 2025 (GLOBE NEWSWIRE) -- Cingulate Inc. (NASDAQ: CING), a biopharmaceutical company utilizing its proprietary Precision Timed Release™ (PTR™) drug delivery platform technology to build and advance a pipeline... -
Protagonist and Takeda Announce Positive Topline Results from Phase 3 VERIFY Study of Rusfertide in Patients with Polycythemia Vera
NEWARK, California, OSAKA, Japan and CAMBRIDGE, Massachusetts, March 3, 2025 – Protagonist Therapeutics, Inc. (“Protagonist”) (NASDAQ:PTGX) and Takeda (TSE:4502/NYSE:TAK) today announced positive topline results for the Phase 3... -
Omalizumab Treats Multi-Food Allergy Better Than Oral Immunotherapy
Monday, March 3, 2025 -- A clinical trial has found that the medication omalizumab, marketed as Xolair, treated multi-food allergy more effectively than oral immunotherapy (OIT) in people with allergic reactions to very small amounts of common food... -
FDA Grants Orphan Drug Designation for Bexmarilimab in MDS
TURKU, Finland March 3, 2025 – Faron Pharmaceuticals Ltd. (AIM: FARN, First North: FARON), a clinical-stage biopharmaceutical company pursuing a CLEVER-1 receptor targeting approach to reprogramming myeloid cells to activate anti-tumor... -
Phase III Study Shows Xolair May Be More Effective With Fewer Side Effects Than Oral Immunotherapy for the Treatment of Food Allergies
South San Francisco, CA -- March 2, 2025 -- Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced today new positive data from Stage 2 and Stage 3 of the National Institutes of Health (NIH)-sponsored Phase III OUtMATCH... -
Depemokimab Delivers Clinically Meaningful and Statistically Significant Improvements for Patients with Chronic Rhinosinusitis with Nasal Polyps (CRSwNP)
01 March 2025 -- GSK plc (LSE/NYSE: GSK) today announced full results from the positive ANCHOR-1 and ANCHOR-2 phase III clinical trials assessing the efficacy and safety of depemokimab versus placebo (both with standard of care [SOC]) in adults with... -
BlueRock Therapeutics Receives FDA Fast Track Designation for OpCT-001 for the Treatment of Primary Photoreceptor Diseases
Berlin, Germany, and Cambridge, MA, USA February 27, 2025 – Bayer AG and BlueRock Therapeutics LP, a clinical-stage cell therapy company and wholly owned subsidiary of Bayer AG, today announced that the U.S. Food and Drug Administration (FDA)... -
Camizestrant Demonstrated Highly Statistically Significant and Clinically Meaningful Improvement in Progression-Free Survival in 1st-Line Advanced HR-Positive Breast Cancer with an Emergent ESR1 Tumor Mutation in SERENA-6 Phase III Trial
26 February 2025 -- Positive high-level results from a planned interim analysis of the SERENA-6 Phase III trial showed that AstraZeneca’s camizestrant in combination with a cyclin-dependent kinase (CDK) 4/6 inhibitor (palbociclib, ribociclib... -
Opus Genetics Announces FDA Fast Track and Enrollment Updates for Phentolamine Ophthalmic Solution 0.75% Programs
DURHAM, N.C., Feb. 26, 2025 (GLOBE NEWSWIRE) -- Opus Genetics, Inc. (Nasdaq: IRD), a clinical-stage ophthalmic biotechnology company developing gene therapies for the treatment of inherited retinal diseases (IRDs) and other ophthalmic disorders... -
Pyxis Oncology Granted FDA Fast Track Designation for PYX-201 Monotherapy in Patients with Recurrent or Metastatic Head and Neck Cancer
BOSTON, Feb. 26, 2025 (GLOBE NEWSWIRE) -- Pyxis Oncology, Inc. (Nasdaq: PYXS), a clinical-stage company developing next-generation therapeutics for difficult-to-treat cancers, today announced that the U.S. Food and Drug Administration (FDA) has... -
Emalex Biosciences’ Lead Candidate Meets Primary and Secondary Endpoints in Phase 3 Tourette Syndrome Study
CHICAGO—February 25, 2025—Emalex Biosciences announced positive topline data from its Phase 3 registrational study of ecopipam, a novel dopamine-1 receptor antagonist, in subjects with Tourette syndrome. The company will meet with the... -
Auron Therapeutics Announces AUTX-703 Granted Fast Track Designation by the FDA for Relapsed or Refractory Acute Myelogenous Leukemia
Newton, MA, February 24, 2025 – Auron Therapeutics, a clinical-stage biotechnology company targeting cell-state plasticity to improve patient out comes in oncology and inflammatory disease, today announced that the U.S. Food and Drug... -
BioRestorative Receives FDA Fast Track Designation for BRTX-100 Chronic Lumbar Disc Disease Program
MELVILLE, N.Y., Feb. 20, 2025 (GLOBE NEWSWIRE) -- BioRestorative Therapies, Inc. (“BioRestorative”, “BRTX” or the “Company”) (NASDAQ:BRTX), a clinical stage regenerative medicine innovator focused on stem... -
Clarity Receives US FDA Fast Track Designation for the Treatment of Metastatic Castration-Resistant Prostate Cancer Patients with Cu-67 SAR-bisPSMA
Sydney, Australia 19 February 2025 Clarity Pharmaceuticals (ASX: CU6) (“Clarity” or “Company”), a clinical-stage radiopharmaceutical company with a mission to develop next-generation products that improve treatment outcomes... -
Boehringer’s Zongertinib Receives Priority Review from U.S. FDA for the Treatment of HER2 (ERBB2)-Mutant Advanced Non-Small Cell Lung Cancer
Ridgefield, Conn., and Ingelheim, Germany, Feb. 19, 2025 -- Boehringer Ingelheim today announced that the U.S. Food and Drug Administration (FDA) has granted Priority Review to its new drug application for zongertinib (BI 1810631) for the treatment... -
U.S. FDA Accepts Gilead’s New Drug Applications for Twice-Yearly Lenacapavir for HIV Prevention Under Priority Review
FOSTER CITY, Calif.--(BUSINESS WIRE) February 18, 2025 -- Gilead Sciences, Inc. (Nasdaq: GILD) today announced that the U.S. Food and Drug Administration (FDA) has accepted its New Drug Application (NDA) submissions for lenacapavir—the... -
Innate Pharma Announces U.S. FDA Granted Breakthrough Therapy Designation to Lacutamab for Relapsed or Refractory Sézary Syndrome
February 17, 2025 -- Innate Pharma SA (Euronext Paris: IPH; Nasdaq: IPHA) (“Innate” or the “Company”) today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation (BTD) to... -
Innovent Receives Second Fast Track Designation from the U.S. FDA for IBI363 (PD-1/IL-2α-bias Bispecific Antibody Fusion Protein) in Squamous Non-Small Cell Lung Cancer
SAN FRANCISCO, U.S. and SUZHOU, China, February 17, 2025 — Innovent Biologics, Inc. (“Innovent”) (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures, and commercializes high-quality medicines for the... -
FDA Grants Fast Track Designation to PleoPharma, Inc's Investigational New Drug, PP-01, for the Mitigation of Cannabis Withdrawal Symptoms in Patients With Cannabis Use Disorder
PHOENIXVILLE, Pa., Feb. 13, 2025 /PRNewswire/ -- PleoPharma, Inc., a privately held company focused on finding treatments for cannabis related health issues, announced today that the U.S. Food and Drug Administration (FDA) has granted Fast Track... -
Lundbeck’s Potential Treatment Amlenetug for Multiple System Atrophy Receives Fast Track Designation From the FDA
Wed, Feb 12, 2025 -- The FDA has granted Fast Track Designation to Lundbeck’s investigational drug, amlenetug, a potential new treatment option targeting Multiple System Atrophy (MSA). Lundbeck has recently initiated MASCOT, a phase III trial... -
Single Dose of Broadly Neutralizing Antibody Protects Macaques from H5N1 Influenza
February 11, 2025 -- National Institutes of Health (NIH) scientists and their colleagues report that a single dose of a broadly neutralizing antibody (bnAb) administered prior to virus exposure protects macaques from severe H5N1 avian influenza... -
NIH-Funded Clinical Trial Will Evaluate New Dengue Therapeutic
February 11, 2025 -- A clinical trial supported by the National Institutes of Health (NIH) is testing an experimental treatment designed to help people suffering the effects of dengue, a mosquito-borne viral disease. The study is supported by... -
Spinogenix Completes Phase 2 Study of SPG601 for Treatment of Fragile X Syndrome, a Common Inherited Form of Autism, Showing Strong Efficacy Signal in Measures of Abnormal Brain Activity
LOS ANGELES, Calif., February 11, 2025 — Spinogenix, Inc., a clinical-stage biopharmaceutical company pioneering first-in-class therapeutics that restore synapses to improve the lives of patients worldwide, today announced topline results from... -
Boehringer’s Nerandomilast Meets Primary Endpoint in Phase III Study FIBRONEER™-ILD, in Progressive Pulmonary Fibrosis
Ingelheim, Germany, February 10, 2025 - Boehringer Ingelheim announced today that the FIBRONEER™-ILD trial met its primary endpoint, which was the absolute change from baseline in forced vital capacity (FVC) [mL] at week 52 versus placebo... -
Nektar Therapeutics Receives Fast Track Designation for Rezpegaldesleukin for the Treatment of Moderate-to-Severe Atopic Dermatitis
SAN FRANCISCO, Feb. 10, 2025 /PRNewswire/ -- Nektar Therapeutics (Nasdaq: NKTR) today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for rezpegaldesleukin for the treatment of adult and pediatric... -
Tempest Granted Fast Track Designation from the U.S. Food and Drug Administration for Amezalpat to Treat Patients with Hepatocellular Carcinoma
BRISBANE, Calif., Feb. 10, 2025 (GLOBE NEWSWIRE) -- Tempest Therapeutics, Inc. (Nasdaq: TPST), a clinical-stage biotechnology company developing first-in-classi targeted and immune-mediated therapeutics to fight cancer, today announced that the U.S... -
Palvella Therapeutics to Expand Phase 3 SELVA Clinical Trial of Qtorin 3.9% Rapamycin Anhydrous Gel (Qtorin rapamycin) for the Treatment of Microcystic Lymphatic Malformations to Include the Younger Pediatric Population, Children 3 to 5 Years Old
WAYNE, Pa., Feb. 10, 2025 (GLOBE NEWSWIRE) -- (Nasdaq: PVLA) Palvella Therapeutics, Inc. (Palvella), a clinical-stage biopharmaceutical company focused on developing and commercializing novel therapies to treat patients suffering from serious, rare...
