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intravenous lipid
intravenous lipid is a Parenteral nutrition Small molecule drug developed by University of Rochester. It is currently in Phase 3 development for Parenteral nutrition for patients who cannot receive feedings or fluids by mouth.
Intravenous lipid emulsions provide a source of calories and essential fatty acids.
IMC-002 is a small molecule being studied as a potential treatment for various conditions, including Neuromyelitis Optica Spectrum Disorder (NMOSD), Bone Infection, Osteomyelitis, Septic Arthritis, and Joint Infection. The exact mechanism of IMC-002 is not specified in the available information, but it is classified as a small molecule.
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Baseline phase 3 → approval rate
+58.3pp
Industry-wide phase 3 drugs reach approval ~58.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas). -
Big-pharma sponsor
+3.0pp
University of Rochester is a top-20 pharma sponsor — historical approval rates run ~3pp above average due to scale, regulatory experience, and trial-design quality.
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2028–2030 | — |
| EMA | EU | 2029–2031 | +0.7 yr |
| MHRA | GB | 2029–2031 | +0.7 yr |
| Health Canada | CA | 2029–2032 | +0.9 yr |
| TGA | AU | 2029–2032 | +1.2 yr |
| PMDA | JP | 2029–2032 | +1.5 yr |
| NMPA | CN | 2030–2033 | +2.3 yr |
| MFDS | KR | 2029–2032 | +1.4 yr |
| CDSCO | IN | 2029–2033 | +1.8 yr |
| ANVISA | BR | 2030–2033 | +2.3 yr |
Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).
Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.
At a glance
| Generic name | intravenous lipid |
|---|---|
| Sponsor | University of Rochester |
| Drug class | Parenteral nutrition |
| Modality | Small molecule |
| Therapeutic area | Nutritional Support |
| Phase | Phase 3 |
Mechanism of action
They are used to provide nutritional support, especially in patients who have difficulty absorbing nutrients through the digestive system. This can be due to various conditions such as short bowel syndrome or severe pancreatitis.
Approved indications
- Parenteral nutrition for patients who cannot receive feedings or fluids by mouth
Common side effects
- Infection
- Allergic reactions
- Metabolic disturbances
Key clinical trials
- Epigenetic Regulation of Human Adipose Tissue Distribution (NA)
- RNA-lipid Particle (RNA-LP) Vaccines for Recurrent/Progressive Medulloblastoma (MB) (PHASE1)
- A Safety and Tolerability Trial Evaluating CTX310 in Participants With Refractory Dyslipidemias (PHASE1)
- Vitamin E Pharmacokinetics and Biomarkers in Normal and Obese Women (PHASE1)
- Study of Efficacy, Safety, Tolerability, Pharmacokinetic (PK) and Pharmacodynamic (PD) of an Anti-CD40 Monoclonal Antibody, CFZ533, in Kidney Transplant Recipients (PHASE2)
- Evaluation of Intravenous Sodium Valproate on Interleukin-6 Levels in Patients With TMJ Disc Displacement (PHASE2)
- A Phase 3 Efficacy and Safety Study of Fosmanogepix for the Treatment of Adult Participants With Candidemia and/or Invasive Candidiasis. (PHASE3)
- Testing a Novel Combination Treatment (Arm D) Versus Standard of Care for Intensive Phase Treatment for Mycobacterium Abscessus Pulmonary Disease in People With or Without Cystic Fibrosis in the Finding the Optimal Regimen for Mycobacterium Abscessus Treatment (FORMaT) Adaptive Platform Trial (PHASE2)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- intravenous lipid CI brief — competitive landscape report
- intravenous lipid updates RSS · CI watch RSS
- University of Rochester portfolio CI
Frequently asked questions about intravenous lipid
What is intravenous lipid?
How does intravenous lipid work?
What is intravenous lipid used for?
Who makes intravenous lipid?
What drug class is intravenous lipid in?
What development phase is intravenous lipid in?
What are the side effects of intravenous lipid?
Related
- Drug class: All Parenteral nutrition drugs
- Manufacturer: University of Rochester — full pipeline
- Therapeutic area: All drugs in Nutritional Support
- Indication: Drugs for Parenteral nutrition for patients who cannot receive feedings or fluids by mouth
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing