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Cylophosphamide
Cylophosphamide is a Small molecule drug developed by G1 Therapeutics, Inc.. It is currently in Phase 2 development. Also known as: CYTOXAN®.
Cylophosphamide is used to treat various types of blood cancers, including Acute Lymphoblastic Leukemia, Lymphoma, and Relapsed or Refractory Multiple Myeloma. It is often used in combination with other treatments, such as Allogeneic Bone Marrow Transplantation and Chemotherapy, as seen in clinical trials like NCT03856216.
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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).
| 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 | Cylophosphamide |
|---|---|
| Also known as | CYTOXAN® |
| Sponsor | G1 Therapeutics, Inc. |
| Modality | Small molecule |
| Therapeutic area | Other |
| Phase | Phase 2 |
Approved indications
Common side effects
Key clinical trials
- Inotuzumab Ozogamicin and Chemotherapy in Treating Patients With Leukemia or Lymphoma Undergoing Stem Cell Transplantation (PHASE2)
- CLL-Irl Study. CTRIAL-IE (ICORG) 07-01, V7 (PHASE2)
- Trilaciclib, a CDK4/6 Inhibitor, in Patients With Early-Stage Triple Negative Breast Cancer (PHASE2)
- Selinexor, Cyclophosphamide and Prednisone in Myeloma (PHASE2)
- Scleroderma Lung Disease (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:
- Cylophosphamide CI brief — competitive landscape report
- Cylophosphamide updates RSS · CI watch RSS
- G1 Therapeutics, Inc. portfolio CI
Frequently asked questions about Cylophosphamide
What is Cylophosphamide?
Who makes Cylophosphamide?
Is Cylophosphamide also known as anything else?
What development phase is Cylophosphamide in?
Related
- Manufacturer: G1 Therapeutics, Inc. — full pipeline
- Therapeutic area: All drugs in Other
- Also known as: CYTOXAN®
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing