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Lipid emulsion without progesterone
Lipid emulsion without progesterone is a Small molecule drug developed by BHR Pharma, LLC. It is currently in Phase 3 development.
A lipid emulsion formulation that delivers lipophilic compounds without progesterone as an active pharmaceutical ingredient.
Lipid emulsion without progesterone is being studied as a potential treatment for brain injuries, as seen in a clinical trial registered on ClinicalTrials.gov. The mechanism of lipid emulsion without progesterone is not specified in the provided information, but progesterone itself is a small molecule that acts as a progesterone receptor agonist.
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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).
| 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 | Lipid emulsion without progesterone |
|---|---|
| Sponsor | BHR Pharma, LLC |
| Modality | Small molecule |
| Phase | Phase 3 |
Mechanism of action
Lipid emulsions are colloidal dispersions used as pharmaceutical delivery vehicles to solubilize and transport lipophilic (fat-soluble) drugs. This particular formulation is characterized by the absence of progesterone, suggesting it may be designed to deliver other lipid-soluble active ingredients or serve as a vehicle for alternative therapeutic agents. The specific mechanism depends on the active pharmaceutical ingredient(s) incorporated into the emulsion.
Approved indications
Common side effects
Key clinical trials
- Efficacy and Safety Study of Intravenous Progesterone in Patients With Severe Traumatic Brain Injury (PHASE3)
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:
- Lipid emulsion without progesterone CI brief — competitive landscape report
- Lipid emulsion without progesterone updates RSS · CI watch RSS
- BHR Pharma, LLC portfolio CI
Frequently asked questions about Lipid emulsion without progesterone
What is Lipid emulsion without progesterone?
How does Lipid emulsion without progesterone work?
Who makes Lipid emulsion without progesterone?
What development phase is Lipid emulsion without progesterone in?
Related
- Manufacturer: BHR Pharma, LLC — full pipeline
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing