COMPANY
Fresenius Kabi
FDA-approved therapeutic company FDA-cleared device company Clinical Phase 3
Trial and FDA signals
- FDA complete response letter Received an FDA complete response letter (NDA 215818, letter dated Feb 27, 2026). FDA NDA 215818 (Feb 27, 2026)
Evidence (1 event)
- Feb 27, 2026 · FDA NDA 215818
CRL text (OCR, redacted by FDA; first 200 chars from "COMPLETE RESPONSE"): COMPLETE RESPONSE Fresenius Kabi USA, LLC Attention: Jennifer Gross, MS Senior Regulatory Affairs Associate Lake Zurich, IL (street omitted) Dear Jennifer Gross: Please refer to your new dr
- Feb 27, 2026 · FDA NDA 215818
- FDA complete response letter Received an FDA complete response letter (NDA 214610, letter dated Feb 27, 2026). FDA NDA 214610 (Feb 27, 2026)
Evidence (1 event)
- Feb 27, 2026 · FDA NDA 214610
CRL text (OCR, redacted by FDA; first 200 chars from "COMPLETE RESPONSE"): COMPLETE RESPONSE Fresenius Kabi USA, LLC Attention: Jennifer Gross, M.S. Senior Regulatory Affairs Associate Lake Zurich, IL (street omitted) Dear Jennifer Gross: Please refer to your new
- Feb 27, 2026 · FDA NDA 214610
Timeline
- Trial start Not phased (device or behavioral study): Glycaemic Index Measurement of an Oral Nutritional Supplement With Biomarker Assessment and Lifestyle Monitoring in Healthy Participants source ↗
- FDA FDA 510(k) clearance: KabiHelp® Uno; KabiHelp® Advance plus — K251139, Jan 9, 2026. Applicant at approval: Fresenius Kabi AG. source ↗
- Trial start —: Safety Study to Evaluate the Occurrence of EFAD in Pediatric Patients With PNAC Who Require More Than Eight Weeks of Omegaven Treatment source ↗
- Trial start Phase 4: Safety Study of SMOFlipid to Evaluate the Risk of Developing EFAD and/or PNAC in Pediatric and Adult Patients source ↗
- Trial start —: bIosimilar of aDalimumab, an European evAluation source ↗
- Trial start —: Safety of Omegaven in Pediatric Patients With Parenteral Nutrition-Associated Cholestasis (PNAC) source ↗
- Trial start Phase 3: Efficacy and Safety of SmofKabiven Extra Nitrogen for Parenteral Nutrition in Patients Receiving Intensive Care source ↗
- Trial start —: A Study of the Real-world Use of an Adalimumab Biosimilar and Evaluation of Nutritional Status on the Therapeutic Response source ↗
- Trial start Phase 4: Safety and Efficacy Study to Compare Smoflipid and Intralipid 20% in Pediatric Patients of 3 Months to 16 Years of Age source ↗
- Trial start Phase 4: Reaching Protein Target With SmofKabiven® Extra Nitrogen vs Olimel N9E During the Early Phase of Acute Critical Illness source ↗
- Trial start —: Observational Cohort Study on the Use of Parenteral Nutrition and Clinical Outcomes in Adult Critically Ill Patients source ↗
- Trial start —: Nutrition Insights Day Asia source ↗
- Trial start Phase 4: Safety and Efficacy of a 6% Hydroxyethyl Starch (HES) Solution Versus an Electrolyte Solution in Trauma Patients source ↗
- Trial start Phase 3: Efficacy & Safety of SmofKabiven Emulsion for Infusion vs Hospital Compounded "All in One" for Parenteral Nutrition source ↗
- Trial start Phase 4: Blood Glucose Response After Oral Intake of Lactulose in Mildly Constipated Patients With Diabetes Mellitus Type 2 source ↗
- Trial start —: Quality of Care of Oncological Patients With HPN source ↗
- Trial start —: Chronic Kidney Disease Observational Database - Taiwan source ↗
- Trial start Phase 4: Study to Assess Safety and Efficacy of Kabiven® in Pediatric Patients 2 to 16 Years of Age source ↗
- Trial start Phase 4: Efficacy Study of Long-term Parenteral Nutrition With SmofKabiven® E in Lung Cancer Patients Under Anticancer Therapy source ↗
- Trial start Phase 3: Efficacy and Safety of SmofKabiven Peripheral Versus Compounded Emulsion source ↗
- Trial start —: Three-Chamber Bags Retrospective Study in Spain source ↗
- Trial start Phase 4: Safety and Efficacy of 6% Hydroxyethyl Starch (HES) Solution Versus an Electrolyte Solution in Patients Undergoing Elective Abdominal Surgery source ↗
- Trial start Phase 1/Phase 2: Short-term Metabolic Effects of Ketosteril® Supplemented Low Protein Diet in Pre-dialysis Chronic Kidney Disease (CKD) Patients source ↗
- Trial start Not phased (device or behavioral study): Blood Glucose Response After Oral Intake of Lactulose in Healthy Volunteers source ↗
- Trial start —: Observational Study on CKD Treatment With a Ketosteril Supplemented Protein-restricted Diet (Keto-024-CNI) source ↗
Upcoming milestones
- 2026-12 (ESTIMATED) · Not phased · Glycaemic Index Measurement of an Oral Nutritional Supplement With Biomarker Assessment and Lifestyle Monitoring in Healthy Participants · NCT07479251
- Apr 1, 2028 (ESTIMATED) · · Safety Study to Evaluate the Occurrence of EFAD in Pediatric Patients With PNAC Who Require More Than Eight Weeks of Omegaven Treatment · NCT06274788
Clinical trials (lead sponsor) Showing 50 of 51
| Record | Title | Phase | Status | Start | Primary completion |
|---|---|---|---|---|---|
| NCT06274788 | Safety Study to Evaluate the Occurrence of EFAD in Pediatric Patients With PNAC Who Require More Than Eight Weeks of Omegaven Treatment | Not listed | Recruiting | Dec 15, 2024 | Apr 1, 2028 (estimated) |
| NCT06049680 | Safety Study of SMOFlipid to Evaluate the Risk of Developing EFAD and/or PNAC in Pediatric and Adult Patients | Phase 4 | Recruiting | Oct 28, 2024 | 2026-08 (estimated) |
| NCT07479251 | Glycaemic Index Measurement of an Oral Nutritional Supplement With Biomarker Assessment and Lifestyle Monitoring in Healthy Participants | Not phased (device or behavioral study) | Not yet recruiting | 2026-03 | 2026-12 (estimated) |
| NCT03619564 | Chronic Kidney Disease Observational Database - Taiwan | Not listed | Completed | Aug 1, 2018 | Sep 28, 2021 (actual) |
| NCT05257031 | Efficacy and Safety of SmofKabiven Extra Nitrogen for Parenteral Nutrition in Patients Receiving Intensive Care | Phase 3 | Completed | Feb 12, 2022 | Sep 11, 2022 (actual) |
| NCT03278548 | Safety and Efficacy of 6% Hydroxyethyl Starch (HES) Solution Versus an Electrolyte Solution in Patients Undergoing Elective Abdominal Surgery | Phase 4 | Completed | Sep 28, 2017 | Apr 9, 2022 (actual) |
| NCT05051943 | A Study of the Real-world Use of an Adalimumab Biosimilar and Evaluation of Nutritional Status on the Therapeutic Response | Not listed | Completed | Sep 29, 2020 | Jan 20, 2023 (actual) |
| NCT03563222 | Safety and Efficacy Study to Compare Smoflipid and Intralipid 20% in Pediatric Patients of 3 Months to 16 Years of Age | Phase 4 | Terminated | Dec 18, 2019 | Nov 12, 2020 (actual) |
| NCT03338218 | Safety and Efficacy of a 6% Hydroxyethyl Starch (HES) Solution Versus an Electrolyte Solution in Trauma Patients | Phase 4 | Completed | Feb 23, 2019 | Jun 25, 2022 (actual) |
| NCT04807478 | Safety of Omegaven in Pediatric Patients With Parenteral Nutrition-Associated Cholestasis (PNAC) | Not listed | Withdrawn | Apr 1, 2022 | May 1, 2028 (estimated) |
| NCT02503527 | Efficacy and Safety Study of a Low-carbohydrate Tube Feed in Critically Ill Patients Under Insulin Therapy | Not phased (device or behavioral study) | Terminated | 2015-08 | 2018-08 (actual) |
| NCT03425435 | Quality of Care of Oncological Patients With HPN | Not listed | Terminated | Oct 15, 2018 | Jan 14, 2022 (actual) |
| NCT05190484 | bIosimilar of aDalimumab, an European evAluation | Not listed | Unknown status (ClinicalTrials.gov) | Apr 30, 2022 | Apr 30, 2023 (estimated) |
| NCT02579265 | Phase 3 Study to Compare Safety and Efficacy of Smoflipid 20% to Intralipid 20% in Hospitalized Neonates and Infants | 3 | Terminated | 2015-12 | Apr 3, 2020 (actual) |
| NCT03792087 | Efficacy and Safety of SmofKabiven Peripheral Versus Compounded Emulsion | Phase 3 | Completed | Dec 21, 2017 | Dec 30, 2018 (actual) |
| NCT03792100 | Efficacy & Safety of SmofKabiven Emulsion for Infusion vs Hospital Compounded "All in One" for Parenteral Nutrition | Phase 3 | Completed | Jan 3, 2019 | Jan 23, 2020 (actual) |
| NCT03284398 | Three-Chamber Bags Retrospective Study in Spain | Not listed | Completed | Dec 14, 2017 | May 31, 2019 (actual) |
| NCT03992716 | Reaching Protein Target With SmofKabiven® Extra Nitrogen vs Olimel N9E During the Early Phase of Acute Critical Illness | Phase 4 | Terminated | Nov 26, 2019 | Mar 24, 2020 (actual) |
| NCT04143503 | Observational Cohort Study on the Use of Parenteral Nutrition and Clinical Outcomes in Adult Critically Ill Patients | Not listed | Completed | Nov 5, 2019 | May 13, 2020 (actual) |
| NCT03481894 | Study to Assess Safety and Efficacy of Kabiven® in Pediatric Patients 2 to 16 Years of Age | Phase 4 | Withdrawn | 2018-03 | 2020-03 (estimated) |
| NCT03606603 | Nutrition Insights Day Asia | Not listed | Completed | Mar 15, 2019 | Jun 18, 2019 (actual) |
| NCT03355079 | Efficacy Study of Long-term Parenteral Nutrition With SmofKabiven® E in Lung Cancer Patients Under Anticancer Therapy | Phase 4 | Terminated | Feb 28, 2018 | Apr 5, 2019 (actual) |
| NCT03666546 | Blood Glucose Response After Oral Intake of Lactulose in Mildly Constipated Patients With Diabetes Mellitus Type 2 | Phase 4 | Completed | Nov 26, 2018 | Mar 5, 2019 (actual) |
| NCT02746133 | Observational Study on CKD Treatment With a Ketosteril Supplemented Protein-restricted Diet (Keto-027-CNI) | Not listed | Completed | Jul 25, 2016 | Dec 28, 2018 (actual) |
| NCT02756520 | Observational Study on CKD Treatment With a Ketosteril Supplemented Protein-restricted Diet (Keto-024-CNI) | Not listed | Completed | 2016-09 | Oct 10, 2018 (actual) |
| NCT02649205 | Observational Study on Chronic Kidney Disease Treatment With a Ketosteril Supplemented Protein-restricted Diet | Not listed | Completed | 2016-02 | Oct 9, 2018 (actual) |
| NCT03077048 | Short-term Metabolic Effects of Ketosteril® Supplemented Low Protein Diet in Pre-dialysis Chronic Kidney Disease (CKD) Patients | Phase 1/Phase 2 | Completed | Mar 30, 2017 | Apr 27, 2018 (actual) |
| NCT02795039 | Bioequivalence Study of Fulvestrant Injection 50 mg/mL in Healthy Post-menopausal Female Subjects | Phase 1 | Completed | 2016-06 | Mar 3, 2017 (actual) |
| NCT02968498 | Blood Glucose Response After Oral Intake of Lactulose in Healthy Volunteers | Not phased (device or behavioral study) | Completed | 2016-11 | 2017-02 (actual) |
| NCT00852020 | Safety, Tolerance and Efficacy of an Oral Nutritional Supplement in Chronic Heart Failure and Chronic Obstructive Pulmonary Disease Patients | Not phased (device or behavioral study) | Completed | 2009-04 | 2011-04 (actual) |
| NCT02583880 | Screening Day Latin America | Not listed | Completed | 2015-10 | 2016-09 (actual) |
| NCT02938247 | Tolerance and Compliance of a High Caloric, High Protein Oral Nutritional Supplement - Scheduled Intake | Not phased (device or behavioral study) | Completed | 2016-09 | 2016-10 (actual) |
| NCT02938234 | Tolerance and Compliance of a High Caloric, High Protein Oral Nutritional Supplement - Free Intake | Not phased (device or behavioral study) | Completed | 2016-09 | 2016-10 (actual) |
| NCT00501956 | Intradialytic Parenteral Nutrition in Hemodialysis Patients | Phase 4 | Completed | 2004-07 | 2010-12 (actual) |
| NCT01553617 | VolulyteTM in Cardiac Surgery | Phase 4 | Completed | 2012-10 | 2014-01 (actual) |
| NCT01689506 | Fluid Resuscitation in Patients Suffering From Burns Injury | Phase 4 | Terminated | 2012-12 | 2013-09 (actual) |
| NCT01856998 | Therapeutic Equivalence (TE) Study of Propofol 2% MCT Fresenius (MCT=Medium-Chain Triglycerides) Compared With Diprivan® in Patients Undergoing Elective Surgery | Phase 3 | Completed | 2013-05 | 2014-02 (actual) |
| NCT01241695 | Safety, Acceptability and Efficacy of a Long-term Intervention With a Diabetes-specific Low-carbohydrate, High-mono-unsaturated Fatty Acid Containing Oral Nutritional Supplement on Glycaemic Control in Type 2 Diabetic Patients | Not phased (device or behavioral study) | Completed | 2010-11 | 2011-12 (actual) |
| NCT00694343 | Efficacy of Voluven® for the Prevention of Hypotension During Spinal Anesthesia for Cesarean Section | Phase 4 | Completed | 2008-06 | 2009-12 (actual) |
| NCT00464204 | Effects of Voluven on Hemodynamics and Tolerability of Enteral Nutrition in Patients With Severe Sepsis | Phase 3 | Completed | 2007-07 | 2010-05 (actual) |
| NCT00860405 | Voluven® in Paediatric Patients | Phase 4 | Completed | 2009-03 | 2010-08 (actual) |
| NCT00851448 | Safety, Tolerance and Efficacy of an Oral Nutritional Supplement in Lung Cancer Patients | Not phased (device or behavioral study) | Terminated | 2009-10 | 2011-04 (actual) |
| NCT00363987 | Controlled Study to Evaluate Efficacy and Safety of α-KA Tab With Low Protein Diet (LPD) in Delaying the Progress of Type 2 Diabetic Nephropathy (DN) | Phase 4 | Completed | 2006-05 | 2008-12 (actual) |
| NCT00451646 | Study Comparing the Safety and Tolerance of SMOFlipid 20% in Long-term Treatment With Parenteral Nutrition | Phase 3 | Completed | 2007-10 | 2008-10 (actual) |
| NCT01025167 | The Effect of a New Specific Enteral Formula Compared to a Standard Formula on the Tolerability of a Combined Radio- and Chemotherapy in Cancer Patients | Not phased (device or behavioral study) | Completed | 2006-09 | 2010-01 (actual) |
| NCT00730808 | Effectiveness and Tolerability of an Oral Nutritional Supplement (PreOP Booster) Given Before Surgery | Not phased (device or behavioral study) | Completed | 2008-12 | 2009-11 (actual) |
| NCT00308100 | Hydroxyethyl Starch (130/0.4) for Intravascular Volume Therapy in Liver Transplantation | Phase 4 | Terminated | 2005-10 | 2008-07 (actual) |
| NCT00662376 | Study on Safety, Tolerance and Metabolic Effects of a Nutritional Supplement, Given as a Drink Before Gallbladder Surgery | Not phased (device or behavioral study) | Completed | 2008-04 | 2008-10 (actual) |
| NCT00503334 | Preoperative Oral Nutritional Supplement (preOP Booster) in Visceral Surgery | Not phased (device or behavioral study) | Completed | 2007-07 | 2008-05 (actual) |
| NCT00600678 | Gastric Emptying Study After Administration of a High Caloric Sip Feed | Not phased (device or behavioral study) | Completed | 2007-11 | 2007-12 (actual) |
FDA records (last 2 years)
- FDA 510(k) clearance: KabiHelp® Uno; KabiHelp® Advance plus — K251139, Jan 9, 2026. Applicant at approval: Fresenius Kabi AG. source ↗
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