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Romidepsin cycle 2
Romidepsin cycle 2 is a Small molecule drug developed by ANRS, Emerging Infectious Diseases. It is currently in Phase 1 development.
Romidepsin is a histone deacetylase inhibitor used in the treatment of various conditions, including HIV, pancreatic cancer, multiple myeloma, and T-cell lymphomas. In a Phase 2a study, romidepsin was evaluated with or without 3BNC117 to assess its effects on the HIV-1 reservoir.
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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 | Romidepsin cycle 2 |
|---|---|
| Sponsor | ANRS, Emerging Infectious Diseases |
| Modality | Small molecule |
| Phase | Phase 1 |
Approved indications
Common side effects
- Nausea
- Fatigue
- Thrombocytopenia
- Neutropenia
- Diarrhoea
- Pyrexia
- Anaemia
- Vomiting
- Anorexia
- Constipation
- Headache
- Dysgeusia
Key clinical trials
- Romidepsin, CC-486 (5-azacitidine), Dexamethasone, and Lenalidomide (RAdR) for Relapsed/Refractory T-cell Malignancies (PHASE1)
- Evaluation of the Safety and the Tolerability of a Combination of Two HIV Inducers in Patients With Undetectable Viral Load (PHASE1)
- Study of Pembrolizumab (MK-3475) in Combination With Romidepsin (PHASE1, PHASE2)
- Ro Plus CHOEP as First Line Treatment Before HSCT in Young Patients With Nodal Peripheral T-cell Lymphomas (PHASE1, PHASE2)
- A Phase 2 Multicenter Study of High Dose Chemotherapy With Autologous Stem Cell Transplant Followed by Maintenance Therapy With Romidepsin for the Treatment of T Cell Non-Hodgkin Lymphoma (PHASE2)
- Cisplatin Plus Romidepsin & Nivolumab in Locally Recurrent or Metastatic Triple Negative Breast Cancer (TNBC) (PHASE1, PHASE2)
- Safety and Tolerance of Epigenetic and Immunomodulating Drugs Combined With Chemotherapeutics in Patients Suffering From Advanced Pancreatic Cancer (PHASE1, PHASE2)
- Romidepsin Maintenance After Allogeneic Stem Cell Transplantation (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:
- Romidepsin cycle 2 CI brief — competitive landscape report
- Romidepsin cycle 2 updates RSS · CI watch RSS
- ANRS, Emerging Infectious Diseases portfolio CI
Frequently asked questions about Romidepsin cycle 2
What is Romidepsin cycle 2?
Who makes Romidepsin cycle 2?
What development phase is Romidepsin cycle 2 in?
What are the side effects of Romidepsin cycle 2?
Related
- Manufacturer: ANRS, Emerging Infectious Diseases — full pipeline
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing