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Second phase of induction
Second phase of induction is a Small molecule drug developed by Federal Research Institute of Pediatric Hematology, Oncology and Immunology. It is currently in Phase 1 development.
The second phase of induction in clinical trials studied the treatment of Acute Myeloid Leukemia (AML) and High-risk Myelodysplastic Syndrome (MDS) with intensive chemotherapy, either with or without the addition of Volasertib. This treatment combination was tested in a clinical trial (NCT02198482) conducted by the University of Ulm.
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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 | Second phase of induction |
|---|---|
| Sponsor | Federal Research Institute of Pediatric Hematology, Oncology and Immunology |
| Modality | Small molecule |
| Phase | Phase 1 |
Approved indications
Common side effects
- Nausea
- Vomiting
- Anxiety
- Diarrhoea
- Fatigue
- Neutrophil count decreased
- Restlessness
- Abdominal pain
- Peripheral sensory neuropathy
- Constipation
- Arthralgia
- Hyperhidrosis
Key clinical trials
- Testing the Addition of the Anti-cancer Drug Venetoclax and/or the Anti-cancer Immunotherapy Blinatumomab to the Usual Chemotherapy Treatment for Infants With Newly Diagnosed KMT2A-rearranged or KMT2A-non-rearranged Leukemia (PHASE2)
- Becotatug Vedotin for LA-NPC With a Suboptimal Response to Induction Chemotherapy Combined With Immunotherapy (PHASE2)
- Testing the Addition of an Anti-cancer Drug, Pembrolizumab, to the Usual Intravesical Chemotherapy Treatment (Gemcitabine) for the Treatment of BCG-Unresponsive Non-muscle Invasive Bladder Cancer (PHASE2)
- Durvalumab as Consolidation for Patients LS-SCLC (PHASE2)
- Azacitidine and Gemtuzumab Ozogamicin in Treating Older Patients With Previously Untreated Acute Myeloid Leukemia (PHASE2)
- Venetoclax and HMA Treatment of Older and Unfit Adults With FLT3 Mutated Acute Myeloid Leukemia (AML) (A MyeloMATCH Treatment Trial) (PHASE2)
- A Study to Test the Addition of the Drug Cabozantinib to Chemotherapy in Patients With Newly Diagnosed Osteosarcoma (PHASE2, PHASE3)
- Bevacizumab In Hereditary Hemorrhagic Telangiectasia (PHASE2)
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:
- Second phase of induction CI brief — competitive landscape report
- Second phase of induction updates RSS · CI watch RSS
- Federal Research Institute of Pediatric Hematology, Oncology and Immunology portfolio CI
Frequently asked questions about Second phase of induction
What is Second phase of induction?
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What development phase is Second phase of induction in?
What are the side effects of Second phase of induction?
Related
- Manufacturer: Federal Research Institute of Pediatric Hematology, Oncology and Immunology — full pipeline
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing