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Preview: Drugs.com - Clinical Trials

Drugs.com - Clinical Trials



Clinical trial news from Drugs.com. Comprehensive and up-to-date drug news for both consumers and healthcare professionals.



 



Newly Published Phase 2 Study Found Esketamine Demonstrated Significantly Rapid Improvements in Depressive Symptoms and Suicidality

Mon, 16 Apr 2018 03:04:54 GMT

TITUSVILLE, N.J., April 16, 2018 – The Janssen Pharmaceutical Companies of Johnson & Johnson announced today that data from a Phase 2 proof of concept clinical study of esketamine nasal spray, published in the American Journal of Psychiatry,...



Inventiva Announces a U.S. Phase II Investigator-Initiated Study with Lanifibranor on Non-Alcoholic Fatty Liver Disease in Patients with Type 2 Diabetes

Wed, 04 Apr 2018 06:04:19 GMT

Daix (France), April 4th, 2018 - Inventiva, a biopharmaceutical company developing innovative therapies in nonalcoholic steatohepatitis (NASH), systemic sclerosis (SSc) and mucopolysaccharidosis (MPS), today announced that Dr. Kenneth Cusi, Chief of...



Rigel Announces Topline Data from Proof-of-Concept Phase 2 Study of Fostamatinib in IgA Nephropathy

Tue, 03 Apr 2018 06:04:49 GMT

SOUTH SAN FRANCISCO, Calif., April 3, 2018 /PRNewswire/ -- Rigel Pharmaceuticals, Inc. (Nasdaq:RIGL), today announced topline data from its proof-of-concept Phase 2 study of fostamatinib in patients with IgA nephropathy (IgAN), an orphan autoimmune...



Pfizer Announces Positive Topline Results From Phase 3 ATTR-ACT Study Of Tafamidis In Patients With Transthyretin Cardiomyopathy

Thu, 29 Mar 2018 03:03:59 GMT

Thursday, March 29, 2018 - Pfizer Inc. (NYSE:PFE) announced today that the Tafamidis Phase 3 Transthyretin Cardiomyopathy (ATTR-ACT) study evaluating tafamidis for the treatment of transthyretin cardiomyopathy met its primary endpoint, demonstrating...



Phase III data in The Lancet Show Novartis Siponimod Significantly Improves Outcomes in Patients with Secondary Progressive MS

Fri, 23 Mar 2018 02:03:00 GMT

Basel, March 23, 2018 - Novartis today announced that the full results from the Phase III EXPAND study of oral, once-daily siponimod (BAF312) in secondary progressive multiple sclerosis (SPMS) were published in the peer-reviewed journal The Lancet....



Fennec Pharmaceuticals Receives Fast Track Designation by FDA for Pedmark

Thu, 22 Mar 2018 04:03:12 GMT

RESEARCH TRIANGLE PARK, N.C., March 21, 2018 (GLOBE NEWSWIRE) -- Fennec Pharmaceuticals Inc. (NASDAQ:FENC) (TSX:FRX), a specialty pharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has granted PEDMARK (a unique...



Reata Announces Positive Top-Line Data for Treatment of PH-ILD With Bardoxolone Methyl From the Phase 2 Lariat Trial

Thu, 22 Mar 2018 03:03:41 GMT

IRVING, Texas, March 22, 2018 (GLOBE NEWSWIRE) -- Reata Pharmaceuticals, Inc. (Nasdaq:RETA) (Reata or Company), a clinical-stage biopharmaceutical company, today announced positive top-line data from the Phase 2 LARIAT trial evaluating bardoxolone...



AbbVie Announces Results from Phase 2 Study Evaluating Rovalpituzumab Tesirine (Rova-T) for Third-Line Treatment of Patients with DLL3-Expressing Relapsed/Refractory Small Cell Lung Cancer

Thu, 22 Mar 2018 03:03:06 GMT

NORTH CHICAGO, Ill., March 22, 2018 /PRNewswire/ -- AbbVie (NYSE:ABBV), a global research and development-based biopharmaceutical company, today announced that after consulting with the U.S. Food and Drug Administration (FDA), it will not seek...



Cidara Therapeutics Provides Clinical Data Updates for its Lead Antifungal Rezafungin

Wed, 21 Mar 2018 01:03:08 GMT

SAN DIEGO, March 21, 2018 (GLOBE NEWSWIRE) -- Cidara Therapeutics, Inc. (Nasdaq:CDTX), a biotechnology company developing novel anti-infectives including immunotherapies, today is providing additional details from the positive safety and efficacy...



Trillium Therapeutics' TTI-621 Receives Orphan Drug Designation for the Treatment of Cutaneous T-Cell Lymphoma

Tue, 20 Mar 2018 04:03:32 GMT

Toronto, March 20, 2018 — Trillium Therapeutics Inc. (Nasdaq/TSX: TRIL), an immuno-oncology company developing innovative therapies for the treatment of cancer, today announced that the U.S. Food and Drug Administration (FDA) Office of Orphan...



Cellectar Biosciences Granted Orphan Drug Designation for CLR 131 to Treat Neuroblastoma

Mon, 19 Mar 2018 04:03:55 GMT

MADISON, Wis., March 19, 2018 (GLOBE NEWSWIRE) -- Cellectar Biosciences (Nasdaq:CLRB), a clinical stage biopharmaceutical company focused on the discovery, development and commercialization of drugs for the treatment of cancer, today announces that...



Heron Announces Positive Topline Results From Pivotal Phase 3 Clinical Trials of HTX-011 in Bunionectomy and Hernia Repair

Mon, 19 Mar 2018 04:03:39 GMT

SAN DIEGO--(BUSINESS WIRE)--Mar. 19, 2018-- Heron Therapeutics, Inc. (NASDAQ: HRTX), a commercial-stage biotechnology company focused on improving the lives of patients by developing best-in-class treatments to address some of the most important...



Arena Pharmaceuticals Reports Positive Phase 2 Results from the OASIS Trial for Etrasimod in Patients with Ulcerative Colitis

Mon, 19 Mar 2018 04:03:08 GMT

SAN DIEGO, March 19, 2018 /PRNewswire/ -- Arena Pharmaceuticals, Inc. (NASDAQ: ARNA), today announced positive topline Phase 2 results from the OASIS trial for etrasimod, an investigational, once-daily, orally administered, selective sphingosine...



Janssen Announces U.S. FDA Breakthrough Therapy Designation for Erdafitinib in the Treatment of Metastatic Urothelial Cancer

Thu, 15 Mar 2018 22:03:01 GMT

RARITAN, NJ, March 15, 2018 – The Janssen Pharmaceutical Companies of Johnson & Johnson announced today that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation for erdafitinib in the treatment of...



Humanigen Completes Enrollment of Phase 1 Clinical Trial of Lenzilumab for Treatment of Chronic Myelomonocytic Leukemia

Thu, 15 Mar 2018 05:03:01 GMT

BRISBANE, Calif., March 15, 2018 (GLOBE NEWSWIRE) -- Humanigen, Inc. (OTCQB:HGEN), a biopharmaceutical company pursuing cutting-edge science to develop its proprietary monoclonal antibodies for immunotherapy and oncology treatments, today announced...



AbbVie Announces Positive Topline Results from Second Phase 3 Study Evaluating Investigational Elagolix in Women with Uterine Fibroids

Tue, 13 Mar 2018 23:03:54 GMT

NORTH CHICAGO, Ill., March 13, 2018 /PRNewswire/ -- AbbVie (NYSE:ABBV), a global research and development-based biopharmaceutical company, in cooperation with Neurocrine Biosciences, Inc. (NASDAQ: NBIX), announced that the Phase 3 ELARIS UF-II study...



Savara Initiates Phase 2a Clinical Study of Molgradex for the Treatment of NTM Lung Infection

Tue, 13 Mar 2018 03:03:24 GMT

AUSTIN, TX -- (Marketwired) -- 03/13/18 -- Savara Inc. (NASDAQ: SVRA), an orphan lung disease company, announced today the initiation of a Phase 2a clinical study, OPTIMA, evaluating its lead product candidate Molgradex, an inhaled formulation of...



Sienna Biopharmaceuticals Announces First Patient Dosed In Proof-of-Concept Trial of Topical By Design™ JAK Inhibitor SNA-125 for Atopic Dermatitis

Mon, 12 Mar 2018 02:03:53 GMT

WESTLAKE VILLAGE, Calif., March 12, 2018 (GLOBE NEWSWIRE) -- Sienna Biopharmaceuticals, Inc. (NASDAQ:SNNA) today announced that the first patient has been dosed in the Company’s Phase 1/2 proof-of-concept clinical trial of topical product...



CTI BioPharma Announces Publication of Pacritinib Phase 3 PERSIST-2 Clinical Trial in JAMA Oncology

Fri, 09 Mar 2018 03:03:48 GMT

SEATTLE, March 9, 2018 /PRNewswire/ -- CTI BioPharma Corp. (CTI BioPharma) (NASDAQ: CTIC) today announced that results from the Phase 3 PERSIST-2 clinical trial of pacritinib (an investigational JAK2 inhibitor) have been published online in JAMA...



EIP Pharma Publishes Positive Alzheimer's Disease Clinical Study Data with Neflamapimod

Wed, 07 Mar 2018 01:03:45 GMT

CAMBRIDGE, Mass., March 7, 2018 /PRNewswire/ -- EIP Pharma LLC (www.eippharma.com), a CNS-focused therapeutics company, today announced that the results from a 3-month Phase 2a clinical study with neflamapimod, a brain-penetrant oral small molecule...



Biohaven Enrolls First Patient In Phase 3 Clinical Trial To Evaluate Rimegepant Zydis® ODT In The Acute Treatment Of Migraine

Tue, 06 Mar 2018 03:03:25 GMT

NEW HAVEN, Connecticut, March 6, 2018 /PRNewswire/ — Biohaven Pharmaceutical Holding Company Ltd. (NYSE: BHVN) announced today that it has enrolled the first patient in a Phase 3 clinical trial of the Zydis® orally dissolving tablet (“ODT”)...



GTx Announced New Data Demonstrating Enobosarm’s Potential to Treat Stress Urinary Incontinence

Mon, 05 Mar 2018 03:03:26 GMT

MEMPHIS, Tenn.--(BUSINESS WIRE)--Mar. 5, 2018-- GTx, Inc. (Nasdaq:GTXI) today announced additional results from a Phase 2 proof-of-concept clinical trial of 3 mg enobosarm administered orally in postmenopausal women with stress urinary incontinence...



Trovagene Announces First Patient Successfully Completes Cycle 1 of Treatment with PCM-075 in Combination with Low Dose Cytarabine (LDAC) in AML Trial

Mon, 05 Mar 2018 02:03:40 GMT

SAN DIEGO, March 5, 2018 /PRNewswire/ -- Trovagene, Inc. (NASDAQ: TROV), a precision medicine biotechnology company, developing targeted cancer therapeutics, today announced that the initial patient successfully completed the first cycle 1 of...



Dermira’s Two Phase 3 Trials Evaluating Olumacostat Glasaretil in Patients with Acne Vulgaris Did Not Meet Co-Primary Endpoints

Mon, 05 Mar 2018 01:03:49 GMT

MENLO PARK, Calif., March 05, 2018 (GLOBE NEWSWIRE) -- Dermira, Inc. (NASDAQ:DERM), a biopharmaceutical company dedicated to delivering new therapies to patients living with chronic skin conditions, today announced that the investigational treatment...



Santhera Reports Outcome of Exploratory Trial with Idebenone in PPMS Conducted at the NIH

Mon, 05 Mar 2018 00:03:03 GMT

Pratteln, Switzerland, March 5, 2018 - Santhera Pharmaceuticals (SIX: SANN) announces that the exploratory Phase I/II clinical trial in primary progressive multiple sclerosis (PPMS) conducted as an investigator-initiated trial at the National...



Biogen and AbbVie Announce the Voluntary Worldwide Withdrawal of Marketing Authorizations for Zinbryta (daclizumab) for Relapsing Multiple Sclerosis

Fri, 02 Mar 2018 03:03:53 GMT

CAMBRIDGE, Mass. & NORTH CHICAGO, Ill.--(BUSINESS WIRE) March 2, 2018 --Biogen (Nasdaq:BIIB) and AbbVie (NYSE:ABBV) today announced the voluntary worldwide withdrawal of Zinbryta for relapsing multiple sclerosis. The companies believe that...



INSYS Therapeutics Initiates Phase 3 Clinical Trial of Cannabidiol (CBD) Oral Solution for Treatment of Infantile Spasms

Fri, 02 Mar 2018 03:03:22 GMT

PHOENIX, March 02, 2018 (GLOBE NEWSWIRE) -- INSYS Therapeutics, Inc. (NASDAQ:INSY), a leader in the development, manufacture and commercialization of pharmaceutical cannabinoids and spray technology, today announced the initiation of a Phase 3...



Reata Announces Top-Line Data from the Dose-Escalation Cohorts of the Phase 2 Motor Study of Omaveloxolone in Patients With Mitochondrial Myopathies

Thu, 01 Mar 2018 03:03:28 GMT

IRVING, Texas, March 01, 2018 (GLOBE NEWSWIRE) -- Reata Pharmaceuticals, Inc. (Nasdaq:RETA) (Reata or Company), a clinical-stage biopharmaceutical company, today announced top-line data from the dose-escalation cohorts of the Phase 2 MOTOR trial of...



Celgene Provides Regulatory Update on Ozanimod for the Treatment of Relapsing Multiple Sclerosis

Tue, 27 Feb 2018 02:03:36 GMT

SUMMIT, N.J.--(BUSINESS WIRE) February 27, 2018 -- Celgene Corporation (NASDAQ:CELG) today announced that it has received a Refusal to File letter from the United States Food and Drug Administration (FDA) regarding its New Drug Application (NDA) for...



Summit Announces New Analysis Showing Ezutromid Significantly Reduced Muscle Inflammation in Phase 2 Clinical Trial in DMD

Mon, 26 Feb 2018 03:03:16 GMT

OXFORD, United Kingdom, Feb. 26, 2018 (GLOBE NEWSWIRE) -- Summit Therapeutics plc (NASDAQ:SMMT) (AIM:SUMM) announces further positive findings from PhaseOut DMD, a Phase 2 open-label, multi-centre clinical trial of the utrophin modulator ezutromid...



ObsEva SA Reports Positive Topline Results from IMPLANT2 Phase 3 Clinical Trial of Nolasiban in IVF

Mon, 26 Feb 2018 03:03:14 GMT

Geneva, Switzerland and Boston, MA - 26 February, 2018 - ObsEva SA (NASDAQ: OBSV), a clinical-stage biopharmaceutical company focused on the development and commercialization of novel therapeutics for serious conditions that compromise a woman's...



AbbVie Announces Positive Topline Results from Phase 3 Study Evaluating Investigational Elagolix in Women with Uterine Fibroids

Wed, 21 Feb 2018 02:03:08 GMT

NORTH CHICAGO, Ill., Feb. 21, 2018 /PRNewswire/ -- AbbVie (NYSE:ABBV), a global research and development-based biopharmaceutical company, in cooperation with Neurocrine Biosciences, Inc. (NASDAQ: NBIX), announced that the Phase 3 ELARIS UF-I study...



Loxo Oncology Announces Publication of Larotrectinib Clinical Data in The New England Journal of Medicine

Wed, 21 Feb 2018 02:02:44 GMT

STAMFORD, Conn., Feb. 21, 2018 (GLOBE NEWSWIRE) -- Loxo Oncology, Inc. (Nasdaq:LOXO), a biopharmaceutical company innovating the development of highly selective medicines for patients with genetically defined cancers, and Bayer AG, Germany, today...



Athenex Announces Phase II Clinical Study Results for KX2-391 Ointment for the Treatment of Actinic Keratosis

Tue, 20 Feb 2018 02:03:19 GMT

BUFFALO, N.Y., Feb. 20, 2018 (GLOBE NEWSWIRE) -- Athenex (Nasdaq:ATNX), a global biopharmaceutical company dedicated to the discovery, development and commercialization of novel therapies for the treatment of cancer and related conditions, today...



Aimmune Therapeutics’ Pivotal Phase 3 PALISADE Trial of AR101 Meets Primary Endpoint in Patients With Peanut Allergy

Tue, 20 Feb 2018 02:02:40 GMT

BRISBANE, Calif.--(BUSINESS WIRE)--Feb. 20, 2018-- Aimmune Therapeutics, Inc. (Nasdaq:AIMT), a biopharmaceutical company developing treatments for potentially life-threatening food allergies, today announced that its pivotal Phase 3 PALISADE...



AbbVie Announces New Phase 2 Data for Upadacitinib Showing Clinical and Endoscopic Outcomes in Crohn's Disease at 52 Weeks

Fri, 16 Feb 2018 00:03:17 GMT

NORTH CHICAGO, Ill., Feb. 16, 2018 /PRNewswire/ -- AbbVie (NYSE: ABBV), a global research and development-based biopharmaceutical company, today announced new results from the double-blinded extension phase of the Phase 2 CELEST study, showing that...



Selumetinib Granted Orphan Drug Designation by the U.S. FDA for Neurofibromatosis Type 1

Thu, 15 Feb 2018 01:03:56 GMT

KENILWORTH, N.J.--(BUSINESS WIRE) February 15, 2018 --AstraZeneca and Merck (NYSE:MRK), known as MSD outside the U.S. and Canada, today announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) for...



Pfizer Receives Breakthrough Therapy Designation from FDA for PF-04965842, an oral JAK1 Inhibitor, for the Treatment of Patients with Moderate-to-Severe Atopic Dermatitis

Wed, 14 Feb 2018 05:02:10 GMT

February 14, 2018 - Pfizer Inc. (NYSE:PFE) today announced its once-daily oral Janus kinase 1 (JAK1) inhibitor PF-04965842 received Breakthrough Therapy designation from the U.S. Food and Drug Administration (FDA) for the treatment of patients with...



Neurocrine Biosciences Will File New Drug Application for Opicapone for Parkinson's Disease Based on Existing Pivotal Clinical Trial Data

Wed, 14 Feb 2018 03:02:55 GMT

SAN DIEGO, Feb. 14, 2018 /PRNewswire/ -- Neurocrine Biosciences, Inc. (NASDAQ: NBIX), a biotechnology company focused on neurological and endocrine related disorders, today announced that the U.S. Food and Drug Administration (FDA) has provided...



IRX Therapeutics Announces Initiation of Phase 2 Clinical Trial of IRX-2 in Squamous Cervical or Vulvar Intraepithelial Neoplasia 3

Wed, 14 Feb 2018 02:03:30 GMT

NEW YORK – February 14, 2018 – IRX Therapeutics, Inc. (IRX) today announced that the first patient has been dosed in an investigator-sponsored Phase 2 double-blind, randomized, placebo-controlled clinical trial of IRX-2 in women with squamous...