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PB1046 Subcutaneous Injection
PB1046 Subcutaneous Injection is a Small molecule drug developed by PhaseBio Pharmaceuticals Inc.. It is currently in Phase 1 development.
PB1046 Subcutaneous Injection is being studied for its potential use in treating conditions such as Pulmonary Arterial Hypertension, Acute Respiratory Distress Syndrome, Coronavirus, Hypoxic Respiratory Failure, and Hypoxemic Respiratory Failure. The exact mechanism of PB1046 is currently unknown.
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Baseline phase 1 → approval rate
+9.6pp
Industry-wide phase 1 drugs reach approval ~9.6% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2033–2036 | — |
| EMA | EU | 2034–2037 | +0.7 yr |
| MHRA | GB | 2034–2037 | +0.7 yr |
| Health Canada | CA | 2034–2038 | +0.9 yr |
| TGA | AU | 2034–2038 | +1.2 yr |
| PMDA | JP | 2034–2038 | +1.5 yr |
| NMPA | CN | 2035–2039 | +2.3 yr |
| MFDS | KR | 2034–2038 | +1.4 yr |
| CDSCO | IN | 2034–2039 | +1.8 yr |
| ANVISA | BR | 2035–2039 | +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 | PB1046 Subcutaneous Injection |
|---|---|
| Sponsor | PhaseBio Pharmaceuticals Inc. |
| Modality | Small molecule |
| Phase | Phase 1 |
Approved indications
Common side effects
Key clinical trials
- Phase 2 Study to Assess Safety, Tolerability and Efficacy of Once Weekly SC Pemziviptadil (PB1046) in Subjects With Symptomatic PAH (PHASE2)
- Study to Assess the Safety, Tolerability and PK/PD After 4 Weekly SC Injections of PB1046 in Subjects With Stable HFrEF (PHASE2)
- Long-Term, Open Label Extension Study of Pemziviptadil (PB1046) in PAH Subjects Following Completion of Study PB1046-PT-CL-0004 (PHASE2)
- Pemziviptadil (PB1046), a Long-acting, Sustained Release Human VIP Analogue, Intended to Provide Clinical Improvement to Hospitalized COVID-19 Patients at High Risk for Rapid Clinical Deterioration and Acute Respiratory Distress Syndrome (ARDS). (PHASE2)
- A Study to Assess the Safety, Tolerability, and Hemodynamic Response of PB1046 in Subjects With PAH (PHASE1)
- Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Response of Vasomera (PB1046) Injection Following a Single Subcutaneous Dose in Subjects With Stage 1 or 2 Essential Hypertension (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:
- PB1046 Subcutaneous Injection CI brief — competitive landscape report
- PB1046 Subcutaneous Injection updates RSS · CI watch RSS
- PhaseBio Pharmaceuticals Inc. portfolio CI
Frequently asked questions about PB1046 Subcutaneous Injection
What is PB1046 Subcutaneous Injection?
Who makes PB1046 Subcutaneous Injection?
What development phase is PB1046 Subcutaneous Injection in?
Related
- Manufacturer: PhaseBio Pharmaceuticals Inc. — full pipeline
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing