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Recombinant ADAMTS13
Recombinant ADAMTS13 is a Small molecule drug developed by Takeda. It is currently in Phase 2 development. Also known as: ADZYNMA Intravenous 1500, TAK-755.
Recombinant ADAMTS13 is an enzyme replacement therapy used for the treatment of thrombotic thrombocytopenic purpura. It is a human recombinant a disintegrin and metalloproteinase with thrombospondin motifs 13, classified as a hydrolytic enzyme that targets hyaluronic acid.
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Baseline phase 2 → approval rate
+15.3pp
Industry-wide phase 2 drugs reach approval ~15.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas). -
Big-pharma sponsor
+3.0pp
Takeda 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 | 2031–2034 | — |
| EMA | EU | 2032–2035 | +0.7 yr |
| MHRA | GB | 2032–2035 | +0.7 yr |
| Health Canada | CA | 2032–2036 | +0.9 yr |
| TGA | AU | 2032–2036 | +1.2 yr |
| PMDA | JP | 2032–2036 | +1.5 yr |
| NMPA | CN | 2033–2037 | +2.3 yr |
| MFDS | KR | 2032–2036 | +1.4 yr |
| CDSCO | IN | 2032–2037 | +1.8 yr |
| ANVISA | BR | 2033–2037 | +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 | Recombinant ADAMTS13 |
|---|---|
| Also known as | ADZYNMA Intravenous 1500, TAK-755 |
| Sponsor | Takeda |
| Modality | Small molecule |
| Phase | Phase 2 |
Approved indications
Common side effects
Key clinical trials
- A Study to Learn More About the Treatment of People With Congenital Thrombotic Thrombocytopenic Purpura (cTTP) Who Received Recombinant ADAMTS13 (rADAMTS13) as Part of the Early Access Program
- A Study of TAK-755 (rADAMTS13) With Little to No Plasma Exchange (PEX) Treatment in Adults With Immune-mediated Thrombotic Thrombocytopenic Purpura (iTTP) (PHASE2)
- A Study of TAK-755 in Adults With Acute Ischemic Stroke (PHASE2)
- A Study of BAX 930 in Children, Teenagers, and Adults Born With Thrombotic Thrombocytopenic Purpura (TTP) (PHASE3)
- A Survey of Recombinant ADAMTS13 in Participants With Congenital Thrombotic Thrombocytopenic Purpura
- A Study of TAK-755 in Participants With Congenital Thrombotic Thrombocytopenic Purpura (PHASE3)
- Expanded Access Program of TAK-755 for Congenital Thrombotic Thrombocytopenic Purpura (cTTP)
- A Study of SHP655 (rADAMTS13) in Sickle Cell Disease (PHASE1)
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:
- Recombinant ADAMTS13 CI brief — competitive landscape report
- Recombinant ADAMTS13 updates RSS · CI watch RSS
- Takeda portfolio CI
Frequently asked questions about Recombinant ADAMTS13
What is Recombinant ADAMTS13?
Who makes Recombinant ADAMTS13?
Is Recombinant ADAMTS13 also known as anything else?
What development phase is Recombinant ADAMTS13 in?
Related
- Manufacturer: Takeda — full pipeline
- Also known as: ADZYNMA Intravenous 1500, TAK-755
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing