Last reviewed 2026-05-25 · How we verify

Cafizomide

The First Affiliated Hospital of Soochow University · Phase 1 active Small molecule ✓ Verified May 2026 Quality 0/100

Cafizomide is a Small molecule drug developed by The First Affiliated Hospital of Soochow University. It is currently in Phase 1 development.

Cafizomide is being studied in combination with other treatments for multiple myeloma, specifically in the context of a clinical trial (NCT07015021) that also involves daratumumab, pomalidomide, and dexamethasone. The exact mechanism of action of cafizomide is not specified in the provided information, but it is being tested alongside other treatments for multiple myeloma.

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	Cafizomide
Sponsor	The First Affiliated Hospital of Soochow University
Modality	Small molecule
Therapeutic area	Other
Phase	Phase 1

Approved indications

No approved indications tracked.

Common side effects

No common side effects on file.

Key clinical trials

The Efficacy and Safety of the Combination Therapy of Daratumumab, Cabozantinib, Pomalidomide, and Dexamethasone (D-KPd) in the Treatment of High-risk First-time Relapsed or Primary Refractory MM Pati (NA)

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:

Cafizomide CI brief — competitive landscape report
Cafizomide updates RSS · CI watch RSS
The First Affiliated Hospital of Soochow University portfolio CI

Frequently asked questions about Cafizomide

What is Cafizomide?

Cafizomide is a Small molecule drug developed by The First Affiliated Hospital of Soochow University.

Who makes Cafizomide?

Cafizomide is developed by The First Affiliated Hospital of Soochow University (see full The First Affiliated Hospital of Soochow University pipeline at /company/the-first-affiliated-hospital-of-soochow-university).

What development phase is Cafizomide in?

Cafizomide is in Phase 1.

Manufacturer: The First Affiliated Hospital of Soochow University — full pipeline
Therapeutic area: All drugs in Other

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