COMPANY

Cumberland Pharmaceuticals

HQ: Nashville, TN source · cumberlandpharma.com ↗

FDA-approved therapeutic company Clinical Phase 2

Location: Nashville, TN · source · Oct 14, 2026

Profile checked Oct 10, 2026

Keywords: Gram-Positive Bacterial Infections Fever Hyponatremia Liver Cirrhosis Bacterial Pneumonia Staphylococcal Skin Infection Burns Kidney Diseases Colonoscopy Preparation Liver Disease Diffuse Scleroderma Systemic Scleroderma Limited Scleroderma Progressive Systemic Sclerosis Skin Diseases Connective Tissue Diseases Pathologic Processes Autoimmune Diseases Idiopathic Pulmonary Fibrosis Duchenne Muscular Dystrophy Cardiomyopathy Dilated Cardiomyopathy Aspirin-Induced Asthma Hypercholesterolemia Dyslipidemias Portal Hypertension Pregnancy Bacteremia Abscess Cellulitis Ulcer Wound Infections End Stage Renal Disease Hospital Acquired Bacterial Pneumonia Complicated Skin and Skin Structure Infections Ventilator Associated Bacterial Pneumonia Gram Positive Infection Aspirin Exacerbated Respiratory Disease Hepatorenal Syndrome Tonsillectomy

49Trials (company is sponsor)1FDA records (2 yrs)

Timeline

Nov 26, 2024 FDA FDA New indication / efficacy supplement: ACETADOTE (acetylcysteine) — NDA021539/19, Nov 26, 2024. Applicant at approval: Cumberland Pharmaceuticals Inc. source ↗
Jan 31, 2024 Trial start Phase 2: Oral Ifetroban in Patients With Idiopathic Pulmonary Fibrosis (IPF) source ↗
Oct 19, 2020 Trial start Phase 2: Oral Ifetroban in Subjects With Duchenne Muscular Dystrophy source ↗
Aug 7, 2018 Trial start Phase 2: Dose-ranging Efficacy and Pharmacokinetics Study of Intravenous Atorvastatin in Hypercholesterolemic Patients source ↗
Aug 8, 2017 Trial start Phase 4: Safety and Pharmacokinetic Study of Intravenous Ibuprofen in Pediatric Patients source ↗
Jul 17, 2017 Trial start Phase 2: Oral Ifetroban to Treat Aspirin Exacerbated Respiratory Disease (AERD) source ↗
Mar 6, 2017 Trial start Phase 2: Study to Assess Safety and Efficacy of Ifetroban for Treatment of Portal Hypertension in Cirrhotic Patients source ↗
2017-01 Trial start Phase 2: Oral Ifetroban to Treat Diffuse Cutaneous Systemic Sclerosis (SSc) or SSc-associated Pulmonary Arterial Hypertension source ↗
2014-12 Trial start Phase 1: Telavancin Pediatric PK Study (Ages >12 Months to 17 Years) source ↗
2014-12 Trial start 3: A Phase 3 Telavancin Staphylococcus Aureus (S. Aureus) Bacteremia Trial source ↗
2014-11 Trial start —: Telavancin Observational Use Registry (TOUR) source ↗
2014-08 Trial start Phase 2: Trial to Determine the Safety of Oral Ifetroban in Patients With a History of Aspirin Exacerbated Respiratory Disease source ↗
2014-04 Trial start Phase 2: Efficacy and Safety of Bisacodyl and Lactulose as a Preparation for Colonoscopy source ↗
2013-07 Trial start Phase 4: Efficacy of Intravenous Ibuprofen Compared to Intravenous Ketorolac for Pain Control Following Arthroscopic Knee Surgery source ↗
2013-07 Trial start Phase 2: 2 Regimens of Lactulose for Colonoscopy Preparation in Adults source ↗
2012-09 Trial start Phase 4: A Pilot Study to Determine the Efficacy of Intravenous Ibuprofen for Pain Control Following Arthroscopic Knee Surgery source ↗
2012-02 Trial start Phase 3: A Study to Assess the Efficacy, Safety and Pharmacokinetics of Intravenous Conivaptan (Vaprisol®) in Pediatric Subjects With Euvolemic or Hypervolemic Hyponatremia source ↗
2011-10 Trial start Phase 2: Safety and Pharmacokinetics of Ifetroban in Hepatorenal Syndrome Patients source ↗
2011-07 Trial start Phase 3: Safety and Efficacy of Intravenous Ibuprofen for Treatment of Pain in Pediatric Patients Undergoing Tonsillectomy source ↗
2011-06 Trial start Phase 4: Surgical Surveillance Trial to Evaluate a Shortened Infusion Time of Intravenous Ibuprofen source ↗
2011-06 Trial start Phase 4: Surveillance Trial to Evaluate a Shortened Infusion Time of Intravenous Ibuprofen source ↗
2011-04 Trial start Phase 1: A Study to Assess the Effect of Severe Hepatic Impairment on the Pharmacokinetics of Intravenous Conivaptan source ↗
2010-12 Trial start Phase 1: A Study to Evaluate the Effect of Renal Function on the Biological Activity of Telavancin source ↗
2010-09 Trial start Phase 3: Safety and Efficacy Study of a New Formulation of Acetylcysteine Injection source ↗
2010-07 Trial start Phase 3: Safety, Efficacy, and Pharmacokinetic Study of Intravenous Ibuprofen in Pediatric Patients source ↗

Showing 25 of 50 dated events.

Upcoming milestones

2028-01 (ESTIMATED) · Phase 2 · Oral Ifetroban in Patients With Idiopathic Pulmonary Fibrosis (IPF) · NCT05571059

Estimated primary completion per ClinicalTrials.gov. Dates move.

Clinical trials (lead sponsor) 49

Record	Title	Phase	Status	Start	Primary completion
NCT02682511	Oral Ifetroban to Treat Diffuse Cutaneous Systemic Sclerosis (SSc) or SSc-associated Pulmonary Arterial Hypertension	Phase 2	Active, not recruiting	2017-01	2026-03 (actual)
NCT05571059	Oral Ifetroban in Patients With Idiopathic Pulmonary Fibrosis (IPF)	Phase 2	Recruiting	Jan 31, 2024	2028-01 (estimated)
NCT03340675	Oral Ifetroban in Subjects With Duchenne Muscular Dystrophy	Phase 2	Completed	Oct 19, 2020	Mar 6, 2024 (actual)
NCT03028350	Oral Ifetroban to Treat Aspirin Exacerbated Respiratory Disease (AERD)	Phase 2	Completed	Jul 17, 2017	Apr 25, 2023 (actual)
NCT02013141	Telavancin Pediatric PK Study (Ages >12 Months to 17 Years)	Phase 1	Terminated	2014-12	2021-03 (actual)
NCT01334957	Surgical Surveillance Trial to Evaluate a Shortened Infusion Time of Intravenous Ibuprofen	Phase 4	Completed	2011-06	2012-12 (actual)
NCT01334944	Surveillance Trial to Evaluate a Shortened Infusion Time of Intravenous Ibuprofen	Phase 4	Completed	2011-06	2012-09 (actual)
NCT03611010	Dose-ranging Efficacy and Pharmacokinetics Study of Intravenous Atorvastatin in Hypercholesterolemic Patients	Phase 2	Completed	Aug 7, 2018	Feb 17, 2020 (actual)
NCT02802228	Study to Assess Safety and Efficacy of Ifetroban for Treatment of Portal Hypertension in Cirrhotic Patients	Phase 2	Completed	Mar 6, 2017	Jul 17, 2018 (actual)
NCT02583399	Safety and Pharmacokinetic Study of Intravenous Ibuprofen in Pediatric Patients	Phase 4	Completed	Aug 8, 2017	Jul 2, 2019 (actual)
NCT01130324	VIBATIV Pregnancy Registry	Not listed	Withdrawn	2009-11	2020-10 (actual)
NCT02208063	A Phase 3 Telavancin Staphylococcus Aureus (S. Aureus) Bacteremia Trial	3	Terminated	2014-12	Apr 12, 2018 (actual)
NCT00124020	Comparison of Telavancin and Vancomycin for Hospital-acquired Pneumonia Due to Methicillin-resistant Staphylococcus Aureus	Phase 3	Completed	2005-01	2007-05 (actual)
NCT00107978	Comparison of Telavancin and Vancomycin for Complicated Skin and Skin Structure Infections With a Focus on Methicillin-resistant Staphylococcus Aureus	Phase 3	Completed	2005-02	2006-05 (actual)
NCT00077675	Phase 2 Trial of TD-6424 (Telavancin) Versus Standard Therapy for Complicated Gram Positive Skin and Skin Structure Infections (Gram Positive cSSSI)	2	Completed	2004-02	2004-09 (actual)
NCT00062647	Telavancin for Treatment of Uncomplicated Staphylococcus Aureus Bacteremia	Phase 2	Completed	2003-08	2006-08 (actual)
NCT00107952	Comparison of Telavancin and Vancomycin for Hospital-acquired Pneumonia Due to Methicillin-resistant Staphylococcus Aureus	Phase 3	Completed	2005-02	2007-07 (actual)
NCT00091819	Comparison of Telavancin and Vancomycin for Complicated Skin and Skin Structure Infections With a Focus on Methicillin-resistant Staphylococcus Aureus	Phase 3	Completed	2005-01	2006-06 (actual)
NCT00061633	Phase 2 Trial of TD 6424 (Telavancin) Versus Standard Therapy for Complicated Gram Positive Skin and Skin Structure Infections (Gram Positive cSSSI)	2	Completed	2003-06	2004-01 (actual)
NCT01238796	A Study to Evaluate the Effect of Renal Function on the Biological Activity of Telavancin	Phase 1	Completed	2010-12	2011-02 (actual)
NCT02288234	Telavancin Observational Use Registry (TOUR)	Not listed	Completed	2014-11	2017-06 (actual)
NCT02216357	Trial to Determine the Safety of Oral Ifetroban in Patients With a History of Aspirin Exacerbated Respiratory Disease	Phase 2	Completed	2014-08	2016-01 (actual)
NCT01436500	Safety and Pharmacokinetics of Ifetroban in Hepatorenal Syndrome Patients	Phase 2	Completed	2011-10	2015-06 (actual)
NCT01002573	Safety, Efficacy, and Pharmacokinetic Study of Intravenous Ibuprofen in Pediatric Patients	Phase 3	Completed	2010-07	2013-06 (actual)
NCT01332253	Safety and Efficacy of Intravenous Ibuprofen for Treatment of Pain in Pediatric Patients Undergoing Tonsillectomy	Phase 3	Completed	2011-07	2012-07 (actual)
NCT01650519	A Pilot Study to Determine the Efficacy of Intravenous Ibuprofen for Pain Control Following Arthroscopic Knee Surgery	Phase 4	Completed	2012-09	2012-12 (actual)
NCT00225732	Trial of Caldolor for Treatment of Pain in Post-Operative Adult Patients	Phase 3	Completed	2005-01	2008-01 (actual)
NCT01901393	Efficacy of Intravenous Ibuprofen Compared to Intravenous Ketorolac for Pain Control Following Arthroscopic Knee Surgery	Phase 4	Completed	2013-07	2014-08 (actual)
NCT01451411	A Study to Assess the Efficacy, Safety and Pharmacokinetics of Intravenous Conivaptan (Vaprisol®) in Pediatric Subjects With Euvolemic or Hypervolemic Hyponatremia	Phase 3	Terminated	2012-02	2014-01 (actual)
NCT02123017	Efficacy and Safety of Bisacodyl and Lactulose as a Preparation for Colonoscopy	Phase 2	Completed	2014-04	2014-08 (actual)
NCT00470600	Efficacy and Safety Study of Caldolor (IV Ibuprofen) in Hospitalized Adult Orthopedic Patients	Phase 3	Completed	2007-05	2008-09 (actual)
NCT01887470	2 Regimens of Lactulose for Colonoscopy Preparation in Adults	Phase 2	Completed	2013-07	2013-10 (actual)
NCT00867880	Pharmacokinetic Study Of Ibuprofen Injection (IVIb) In Healthy Adult Subjects	Phase 1	Completed	2009-03	2009-05 (actual)
NCT01118663	Safety and Efficacy Study of a New Formulation of Acetylcysteine Injection	Phase 3	Terminated	2010-09	2012-11 (actual)
NCT00435591	A Study of Multiple Dosing Regimens of IV Conivaptan in Subjects With Euvolemic or Hypervolemic Hyponatremia	Phase 4	Completed	2007-01	2008-09 (actual)
NCT00478192	Study of Efficacy & Safety for 3 Infusion Regimens of IV Conivaptan in Subjects With Euvolemic or Hypervolemic Hyponatremia	Phase 3	Completed	2007-04	2008-08 (actual)
NCT00592475	A Study to Assess the Safety and Effects of Intravenous (IV) Conivaptan on the Hepatic Hemodynamic Response in Cirrhotic Patients	Phase 2	Completed	2007-12	2008-11 (actual)
NCT00843986	Safety and Efficacy of Conivaptan in Hyponatremic Patients With Symptomatic Acute Decompensated Heart Failure (ADHF)	Phase 3	Terminated	2009-04	2009-08 (actual)
NCT00851227	Study to Compare Conivaptan in Subjects With Mild & Moderate Liver Impairment Versus Subjects With Normal Liver Function	Phase 1	Completed	2009-02	2010-01 (actual)
NCT00887627	Study to Compare Conivaptan Pharmacokinetics in Subjects With Mild & Moderate Kidney Function Impairment to Subjects With Normal Kidney Function	Phase 1	Completed	2009-04	2010-07 (actual)
NCT00057356	Safety and Efficacy Study of YM087 (Conivaptan) in Patients With Acute Decompensated Heart Failure	Phase 2	Completed	2002-11	2004-03 (actual)
NCT01370148	A Study to Assess the Effect of Severe Hepatic Impairment on the Pharmacokinetics of Intravenous Conivaptan	Phase 1	Completed	2011-04	2014-02 (actual)
NCT00492037	Study of Efficacy & Safety of Oral YM087 in Subjects With Euvolemic or Hypervolemic Hyponatremia	Phase 3	Completed	2000-01	Not listed
NCT00380575	Study of IV YM087 to Assess Efficacy and Safety in Patients With Euvolemic or Hypervolemic Hyponatremia	Phase 3	Completed	2000-08	Not listed
NCT00379847	An Open-Label Study of YM087 (Conivaptan) in Patients With Euvolemic or Hypervolemic Hyponatremia	Phase 3	Completed	2004-02	2005-06 (actual)
NCT00712543	A Preference Study Comparing Kristalose® and Liquid Lactulose	Phase 4	Completed	2009-06	2009-09 (actual)
NCT00606489	Efficacy and Safety Study of Caldolor (Intravenous Ibuprofen) in Hospitalized Adult and Pediatric Burn Patients	Phase 3	Completed	2007-11	2009-05 (actual)
NCT01131000	Efficacy, Safety, and Pharmacokinetics of Intravenous Ibuprofen in Adult Febrile Patients	Phase 3	Completed	2002-06	2005-08 (actual)
NCT00225706	A Study of Caldolor in Hospitalized Febrile Pediatric Patients	Phase 3	Completed	2005-10	2007-08 (actual)

FDA records (last 2 years)

Nov 26, 2024 FDA New indication / efficacy supplement: ACETADOTE (acetylcysteine) — NDA021539/19, Nov 26, 2024. Applicant at approval: Cumberland Pharmaceuticals Inc. source ↗