Skip to Content

Clinical Trial News

This section provides information about recently completed clinical trials. If you cannot find information about a particular clinical trial, you should note that results may not be available even after the trial ends. Some trials end before completion and results are never published.

Allergan and Gedeon Richter Announce Positive Phase III Results for Ulipristal Acetate 5 and 10 mg in the Treatment of Uterine Fibroids

Posted 4 days ago in Clinical Trials

DUBLIN and BUDAPEST, Hungary, Jan. 17, 2017 /PRNewswire/ -- Allergan Plc (NYSE: AGN) and Gedeon Richter Plc. today announced positive results from Venus II, the second of two pivotal phase III clinical trials evaluating the efficacy and safety of ulipristal acetate in women with abnormal bleeding due to uterine fibroids. A new drug application filing for ulipristal acetate is planned for the second half of...

Read more...

Tetraphase Pharmaceuticals Doses First Patient In IGNITE3 Phase 3 Clinical Trial of Once-Daily IV Eravacycline in cUTI

Posted 4 days ago in Clinical Trials

WATERTOWN, Mass., Jan. 17, 2017 (GLOBE NEWSWIRE) -- Tetraphase Pharmaceuticals, Inc. (NASDAQ:TTPH) today announced dosing of the first patient in IGNITE3, the Company's phase 3 clinical trial evaluating the efficacy and safety of once-daily intravenous (IV) eravacycline compared to ertapenem in complicated urinary tract infections (cUTI). Eravacycline is a novel antibiotic candidate with potent activity against...

Read more...

Sunovion Announces Pivotal Study Results for Novel Drug Candidate Dasotraline Demonstrating Significantly Improved Attention Deficit Hyperactivity Disorder Symptoms in Children Compared to Placebo

Posted 7 days ago in Clinical Trials

MARLBOROUGH, Mass. January 14, 2017 --(BUSINESS WIRE)--Sunovion Pharmaceuticals Inc. (Sunovion) today announced that results of a pivotal Phase 2/3 study (SEP360-202) evaluating novel drug candidate dasotraline in children ages 6 to 12 years with attention deficit hyperactivity disorder (ADHD) showed statistically significant improvement in the 4mg/day dose arm compared to placebo. The 2mg/day dose arm did not...

Read more...

Shionogi Announces Positive Top-Line Results For Cefiderocol Pivotal cUTI Clinical Trial

Posted 8 days ago in Clinical Trials

OSAKA, Japan and FLORHAM PARK, N.J., Jan. 12, 2017 /PRNewswire/ -- Shionogi & Co., Ltd. (hereafter "Shionogi") has announced that cefiderocol (S-649266), a novel siderophore cephalosporin in late-stage development, met the FDA pre-specified primary endpoint for non-inferiority vs imipenem/cilastatin (IPM/CS) in patients with serious complicated urinary tract infection (cUTI) with Gram-negative bacteria. Cefiderocol...

Read more...

VivaGel BV granted QIDP and Fast Track designation by US FDA

Posted 9 days ago in Clinical Trials

Melbourne, Australia; 12 January 2017: Starpharma Holdings Ltd (ASX: SPL, OTCQX: SPHRY) today announced it has been granted Qualified Infectious Disease Product (QIDP) and Fast Track designation for VivaGel® BV by the US Food and Drug Administration (FDA). QIDP and Fast Track designations were granted independently for both the VivaGel® BV treatment and prevention indications for bacterial vaginosis (BV). This p...

Read more...

Incyte and Merck to Advance Clinical Development Program Investigating the Combination of Epacadostat with Keytruda (pembrolizumab)

Posted 12 days ago in Clinical Trials

WILMINGTON, D.E. & KENILWORTH, N.J. January 9, 2017 – Incyte Corporation (Nasdaq:INCY) and Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced the decision to advance the clinical development program investigating the combination of epacadostat, Incyte’s investigational oral selective IDO1 inhibitor, with Keytruda (pembrolizumab), Merck’s anti-PD-1 therapy. With the expansion of th...

Read more...

Esperion Announces Initiation of Three Pivotal Phase 3 Studies for Bempedoic Acid

Posted 13 days ago in Clinical Trials

ANN ARBOR, Mich., Jan. 08, 2017 (GLOBE NEWSWIRE) -- Esperion Therapeutics, Inc. (NASDAQ:ESPR), the lipid management company focused on developing and commercializing complementary oral therapies for the treatment of patients with elevated low density lipoprotein cholesterol (LDL-C), today announced the initiation of the three remaining global pivotal Phase 3 LDL-C lowering efficacy studies of bempedoic acid in...

Read more...

Genprex Announces Positive Interim Data from Phase II Clinical Trial of Oncoprex for Late Stage Non-Small Cell Lung Cancer

Posted 2 weeks ago in Clinical Trials

AUSTIN, TX, January 6, 2017 – Genprex, Inc. today announced positive interim data from an ongoing Phase II clinical trial (NCT01455389) evaluating its investigational immunogene therapy candidate Oncoprex™ in combination with the tyrosine kinase inhibitor (TKI) erlotinib (Tarceva®) for the treatment of late stage non-small cell lung cancer (NSCLC) patients. The clinical trial, which is ongoing at The University of...

Read more...

Neurelis Intranasal Diazepam Treatment For Epilepsy Granted Fast Track Designation By FDA

Posted 2 weeks ago in Clinical Trials

SAN DIEGO, Jan. 4, 2017 /PRNewswire/ -- Neurelis, Inc. today announced that the US Food and Drug Administration (FDA) has designated NRL-1 (intranasal diazepam) as a Fast Track Development program for the management of selected, refractory patients with epilepsy, on a stable regimen of anti-epileptic drugs (AEDs), who require intermittent use of diazepam to control bouts of increased seizures – also referred to as a...

Read more...

Senhwa Biosciences CX-4945 Granted Orphan Drug Designation by the US FDA in Cholangiocarcinoma

Posted 2 weeks ago in Clinical Trials

TAIPEI, Taiwan and SAN DIEGO, Jan. 4, 2017 /PRNewswire/ -- Senhwa Biosciences, Inc. announced today that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation to CX-4945 for the treatment of cholangiocarcinoma. CX-4945 is a novel small molecule drug that inhibits protein kinase CK2, which plays an important role in the DNA damage repair mechanisms of cancer cells. The study drug has...

Read more...

NewVac Reports Primary Endpoint Met in Phase II Clinical Trial of Quisinostat in Combination with Paclitaxel and Carboplatin in Platinum-Resistant Ovarian Cancer

Posted 2 weeks ago in Clinical Trials

SAN DIEGO, Jan. 3, 2017 /PRNewswire/ -- NewVac LLC reported meeting all primary endpoints in the Phase II Clinical Trial of Quisinostat, novel selective oral histone deacetylase (HDAC1) inhibitor, which NewVac licensed from Janssen Pharmaceutica NV. The clinical trial is evaluating the efficacy and safety of Quisinostat in platinum-resistant ovarian cancer in combination with Paclitaxel and Carboplatin. The detailed...

Read more...

Protalix BioTherapeutics Announces Positive Interim Results from Phase II Clinical Trial of alidornase alfa (AIR DNase™) for the Treatment of Cystic Fibrosis

Posted 2 weeks ago in Clinical Trials

CARMIEL, Israel, Jan. 03, 2017 (GLOBE NEWSWIRE) -- Protalix BioTherapeutics, Inc. (NYSE MKT:PLX) (TASE:PLX), announced today positive interim results from the Company’s phase II clinical trial of alidornase alfa for the treatment of Cystic Fibrosis (CF) for the first 13 CF patients enrolled in the study. Fifteen patients have been enrolled in, and are expected to complete, the study. alidornase alfa is a plant c...

Read more...

Innocoll Receives Refusal to File Letter from U.S. FDA for XaraColl (bupivacaine HCl collagen-matrix implants) New Drug Application

Posted 3 weeks ago in Clinical Trials

ATHLONE, Ireland, Dec. 29, 2016 (GLOBE NEWSWIRE) -- Innocoll (NASDAQ:INNL), a global, commercial-stage, specialty pharmaceutical company, today announced that it has received a Refusal to File letter from the United States Food and Drug Administration (FDA) for Xaracoll, the company’s product candidate for the treatment of postsurgical pain. Upon preliminary review, the FDA determined that the application, which w...

Read more...

Anthera Announces the Phase 3 SOLUTION Study with Sollpura in Cystic Fibrosis Patients with Exocrine Pancreatic Insufficiency Demonstrates Encouraging Results - Additional Study Needed

Posted 3 weeks ago in Clinical Trials

HAYWARD, Calif., Dec. 27, 2016 (GLOBE NEWSWIRE) -- Anthera Pharmaceuticals, Inc. (NASDAQ:ANTH) today announced the top line results of the SOLUTION clinical study in cystic fibrosis patients with exocrine pancreatic insufficiency (EPI). The study narrowly missed the CFA non-inferiority margin of the primary modified Intent to Treat (mITT) analysis; however, by additional pre-specified analyses of CFA (mITT-Baseline...

Read more...

Roche’s Emicizumab for Hemophilia A Meets Primary Endpoint in Phase III Study

Posted 4 weeks ago in Clinical Trials

Basel, 22 December 2016 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the primary endpoint has been met for the phase III HAVEN 1 study evaluating emicizumab prophylaxis in people 12 years of age or older with hemophilia A and inhibitors to factor VIII. The study showed a statistically significant reduction in the number of bleeds over time in people treated with emicizumab prophylaxis compared to those...

Read more...

Concert Pharmaceuticals Initiates Phase 2 Clinical Trial Evaluating CTP-656 for the Treatment of Cystic Fibrosis

Posted 4 weeks ago in Clinical Trials

LEXINGTON, Mass.-- December 21, 2016(BUSINESS WIRE) -- Concert Pharmaceuticals, Inc. (NASDAQ: CNCE) today announced the initiation of a U.S.-based Phase 2 clinical trial evaluating CTP-656 (deuterated ivacaftor), a next generation CFTR potentiator being developed for the treatment of cystic fibrosis. CTP-656 was created based on Concert's application of deuterium chemistry to modify ivacaftor, which is commercially...

Read more...

Lexicon Reports Positive Top-Line Results in Second Pivotal Phase 3 Study for Sotagliflozin in Patients with Type 1 Diabetes

Posted 4 weeks ago in Clinical Trials

The Woodlands, Texas, December 21, 2016 – Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX) announced today that its pivotal inTandem2 Phase 3 clinical trial of sotagliflozin met its primary endpoint, showing a statistically significant reduction in A1C at 24 weeks in patients with type 1 diabetes on optimized insulin therapy. Top-line results from the Phase 3 study showed that patients treated with sotagliflozin had m...

Read more...

Cellceutix Reports 24 Core Phase 2b Clinical Trial Sites for Oral Prurisol Treatment of Moderate-To-Severe Psoriasis Initiated and Open for Screening

Posted 4 weeks ago in Clinical Trials

BEVERLY, MA – Dec. 19, 2016 (GLOBE NEWSWIRE) Cellceutix Corporation, (OTCQB: CTIX) (“the Company”), a clinical stage biopharmaceutical company developing innovative therapies with dermatology, oncology, anti-inflammatory, and antibiotic applications, is pleased to announce today that 24 of the 25 (all US based) core Phase 2b clinical trial sites for oral Prurisol in the treatment of moderate-to-severe psoriasis have ...

Read more...

Astellas Announces FDA Fast Track Designation for ASP0892, DNA Vaccine for Mitigation of Severe Hypersensitivity Reactions Due to Peanut Allergy

Posted 4 weeks ago in Clinical Trials

TOKYO, Dec. 20, 2016 /PRNewswire/ -- Astellas Pharma Inc. (President and CEO: Yoshihiko Hatanaka, "Astellas") and Immunomic Therapeutics, Inc. (Founder & CEO: William Hearl, Ph.D., "Immunomic Therapeutics") today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for the drug candidate ASP0892 for the mitigation of severe hypersensitivity reactions due to peanut allergy....

Read more...

Juno Therapeutics' and Celgene Corporation's Investigational Drug JCAR017 Granted Breakthrough Therapy Designation from FDA for Relapsed/Refractory Diffuse Large B-cell Lymphoma

Posted 4 weeks ago in Clinical Trials

SEATTLE & SUMMIT, N.J.--(BUSINESS WIRE) December 20, 2016 -- Juno Therapeutics, Inc. (NASDAQ: JUNO) and Celgene Corporation (NASDAQ: CELG), today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to investigational drug JCAR017 for the treatment of patients with relapsed/refractory (r/r) aggressive large B-cell non-Hodgkin lymphoma (NHL), including diffuse large...

Read more...
Older articles
Hide