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red blood cell transfusion trigger
red blood cell transfusion trigger is a Small molecule drug developed by Johann Wolfgang Goethe University Hospital. It is currently in Phase 3 development for Treatment of anemia due to chronic kidney disease, Treatment of anemia due to cancer chemotherapy.
Red blood cell transfusions involve the transfer of red blood cells from a donor to a patient to increase red blood cell count and improve oxygen delivery to tissues.
Red blood cell transfusions are typically considered for patients with a hematocrit value less than 24%. This threshold is based on a restrictive transfusion strategy, as seen in the "Restrictive Transfusion Strategy Early After Cardiac Surgery" study (NCT02761564).
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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 | red blood cell transfusion trigger |
|---|---|
| Sponsor | Johann Wolfgang Goethe University Hospital |
| Modality | Small molecule |
| Therapeutic area | Hematology |
| Phase | Phase 3 |
Mechanism of action
This process is typically performed in patients with severe anemia or blood loss due to trauma, surgery, or other medical conditions. The transfused red blood cells help to restore normal red blood cell function and alleviate symptoms such as fatigue, shortness of breath, and dizziness.
Approved indications
- Treatment of anemia due to chronic kidney disease
- Treatment of anemia due to cancer chemotherapy
Common side effects
- Hypotension
- Allergic reactions
- Fever
- Nausea and vomiting
- Headache
Key clinical trials
- Liberal Transfusion Strategy in Elderly Patients (PHASE3)
- Hemoglobin Levels for Blood Transfusions During and After Surgery (NA)
- Red Blood Cell Transfusion in ECMO - A Feasibility Trial (NA)
- Evaluation of Alternative Transfusion Triggers in Hemodynamically Stable, Non-Ventilated Cancer Patients
- Outcomes of Patient Blood Management in Patients Undergoing Major Surgery
- Restrictive Versus Liberal Thresholds for RBC Transfusion in ECMO (NA)
- SAHaRA: A Randomized Controlled Trial (NA)
- Clinical Trial of West-China Perioperative Transfusion Score (WCPTS）for Massive Hemorrhagic Surgery (NA)
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:
- red blood cell transfusion trigger CI brief — competitive landscape report
- red blood cell transfusion trigger updates RSS · CI watch RSS
- Johann Wolfgang Goethe University Hospital portfolio CI
Frequently asked questions about red blood cell transfusion trigger
What is red blood cell transfusion trigger?
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What is red blood cell transfusion trigger used for?
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Related
- Manufacturer: Johann Wolfgang Goethe University Hospital — full pipeline
- Therapeutic area: All drugs in Hematology
- Indication: Drugs for Treatment of anemia due to chronic kidney disease
- Indication: Drugs for Treatment of anemia due to cancer chemotherapy
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing