Last reviewed 2026-05-25 · How we verify

Romidepsin and CHOP

The Lymphoma Academic Research Organisation · Phase 1 active Small molecule ✓ Verified May 2026

Romidepsin and CHOP is a Small molecule drug developed by The Lymphoma Academic Research Organisation. It is currently in Phase 1 development.

Romidepsin is used in combination with CHOP (a chemotherapy regimen) to treat Peripheral T-cell Lymphoma, as seen in clinical trials such as the Ro-CHOP Study (NCT01796002). The Ro-CHOP Study is a Phase 3 randomized study comparing the efficacy and safety of Romidepsin plus CHOP to CHOP alone in patients with untreated Peripheral T-cell Lymphoma.

Likelihood of approval

9.6% vs 9.6% industry baseline

If approved by FDA: likely 2033–2036

Steps remaining: Phase 2 → Phase 3 → NDA/BLA submission

Confidence: Medium

Why this estimate

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).

Predicted approval windows by jurisdiction (conditional on FDA approval)

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 and CHOP
Sponsor	The Lymphoma Academic Research Organisation
Modality	Small molecule
Phase	Phase 1

Approved indications

No approved indications tracked.

Common side effects

No common side effects on file.

Key clinical trials

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 and CHOP CI brief — competitive landscape report
Romidepsin and CHOP updates RSS · CI watch RSS
The Lymphoma Academic Research Organisation portfolio CI

Frequently asked questions about Romidepsin and CHOP

What is Romidepsin and CHOP?

Romidepsin and CHOP is a Small molecule drug developed by The Lymphoma Academic Research Organisation.

Who makes Romidepsin and CHOP?

Romidepsin and CHOP is developed by The Lymphoma Academic Research Organisation (see full The Lymphoma Academic Research Organisation pipeline at /company/the-lymphoma-academic-research-organisation).

What development phase is Romidepsin and CHOP in?

Romidepsin and CHOP is in Phase 1.

Manufacturer: The Lymphoma Academic Research Organisation — full pipeline

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing