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Prophylactic platelet transfusion
Prophylactic platelet transfusion is a Blood product Biologic drug developed by Technische Universität Dresden. It is currently in Phase 3 development for Prevention of bleeding in patients with thrombocytopenia.
Prophylactic platelet transfusion involves administering platelets to prevent bleeding in patients with low platelet counts.
Prophylactic platelet transfusion involves administering platelets to prevent bleeding in patients with low platelet counts. Used for Prevention of bleeding in patients with thrombocytopenia.
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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 | Prophylactic platelet transfusion |
|---|---|
| Sponsor | Technische Universität Dresden |
| Drug class | Blood product |
| Modality | Biologic |
| Therapeutic area | Hematology |
| Phase | Phase 3 |
Mechanism of action
This treatment aims to increase the number of platelets in the blood to prevent bleeding complications. Platelet transfusions are typically used in patients with thrombocytopenia, a condition characterized by low platelet counts. The transfused platelets help to form blood clots and prevent excessive bleeding.
Approved indications
- Prevention of bleeding in patients with thrombocytopenia
Common side effects
- Febrile non-hemolytic transfusion reaction
Key clinical trials
- Canadian Critical Care Comparative Effectiveness Platform (PHASE3)
- A Platform Protocol to Investigate Post-Transplant Cyclophosphamide-Based Graft-Versus-Host Disease Prophylaxis in Patients With Hematologic Malignancies Undergoing Mismatched Unrelated Donor Peripheral Blood Stem Cell Transplantation (PHASE2)
- Platelet Transfusions in Hematopoietic Stem Cell Transplantation (The PATH III Trial) (PHASE3)
- Platelet Cryopreservation
- PRedicting OutcomeS in Preterm nEonates With thromboCyTopenia
- Preventive Strategies for Early and Late Complications of Leptospirosis (PHASE2)
- Coagulation in Cirrhosis (PHASE4)
- Rotational Thromboelastometry Versus Conventional Haemostatic Tests in Children With Decompensated Cirrhosis Undergoing Invasive Procedures. (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:
- Prophylactic platelet transfusion CI brief — competitive landscape report
- Prophylactic platelet transfusion updates RSS · CI watch RSS
- Technische Universität Dresden portfolio CI
Frequently asked questions about Prophylactic platelet transfusion
What is Prophylactic platelet transfusion?
How does Prophylactic platelet transfusion work?
What is Prophylactic platelet transfusion used for?
Who makes Prophylactic platelet transfusion?
What drug class is Prophylactic platelet transfusion in?
What development phase is Prophylactic platelet transfusion in?
What are the side effects of Prophylactic platelet transfusion?
Related
- Drug class: All Blood product drugs
- Manufacturer: Technische Universität Dresden — full pipeline
- Therapeutic area: All drugs in Hematology
- Indication: Drugs for Prevention of bleeding in patients with thrombocytopenia
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing