Last reviewed · How we verify
Therapeutic Dose 1
Therapeutic Dose 1 is a Small molecule drug developed by Chiesi Farmaceutici S.p.A.. It is currently in Phase 1 development.
Therapeutic dose 1 is not specified in the provided facts. However, based on the interventions listed on ClinicalTrials.gov, Sirolimus, Mitoxantrone, and Etoposide are being studied in various clinical trials for conditions including Recurrent Adult Acute Myeloid Leukemia, Secondary Acute Myeloid Leukemia, and Prostate Cancer.
-
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 | Therapeutic Dose 1 |
|---|---|
| Sponsor | Chiesi Farmaceutici S.p.A. |
| Modality | Small molecule |
| Phase | Phase 1 |
Approved indications
Common side effects
Key clinical trials
- Dose-escalation of Regorafenib in Advanced Hepatocellular Carcinoma (PHASE2)
- A Study to Investigate the Efficacy, Safety, and Tolerability of DFV890 and MAS825 for Inflammatory Marker Reduction in Adult Participants With Coronary Heart Disease and Clonal Hematopoiesis of Indeterminate Potential (CHIP) (PHASE2)
- MK-4646 Multiple Dose Trial in Participants With Human Immunodeficiency Virus Type 1 (HIV-1) (MK-4646-003) (PHASE1)
- A Phase 1 Study of IM-1021 in Participants With Advanced Cancer (PHASE1)
- Screening and Multiple Intervention on Lung Epidemics (PHASE2)
- A Study of SGT-501 Gene Therapy in Catecholaminergic Polymorphic Ventricular Tachycardia (CPVT) (PHASE1)
- Testing the Combination of Two Anti-cancer Drugs, DS-8201a and AZD6738, for The Treatment of Advanced Solid Tumors Expressing the HER2 Protein or Gene, The DASH Trial (PHASE1)
- Paclitaxel and Carboplatin With or Without Bevacizumab in Treating Patients With Stage II, Stage III, or Stage IV Ovarian Epithelial Cancer, Primary Peritoneal Cancer, or Fallopian Tube Cancer (PHASE3)
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:
- Therapeutic Dose 1 CI brief — competitive landscape report
- Therapeutic Dose 1 updates RSS · CI watch RSS
- Chiesi Farmaceutici S.p.A. portfolio CI
Frequently asked questions about Therapeutic Dose 1
What is Therapeutic Dose 1?
Who makes Therapeutic Dose 1?
What development phase is Therapeutic Dose 1 in?
Related
- Manufacturer: Chiesi Farmaceutici S.p.A. — full pipeline
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing