Evidence review: Open Peptide Project (verified against primary PubMed, ClinicalTrials.gov & FDA records) · Last checked 2026-10-27. ← Back to Evidence Library
Bortezomib (Velcade, PS-341): what the evidence says
At a glance
What it is: a modified dipeptide boronic acid that reversibly blocks the proteasome. Approved as Velcade in May 2003. R1, R2 It is a modified dipeptide, at the edge of what counts as a peptide.
What the evidence says: Human in APEX (669 patients with relapsed myeloma), it beat high-dose dexamethasone on response (38% vs 18%), time to progression and 1-year survival (80% vs 66%). R3
Biggest risks: peripheral neuropathy, low blood pressure, heart and lung toxicity; fatal events have occurred when given intrathecally. R2
Rating
| Human Human evidence | Strong: APEX RCT (n = 669) R3 |
| Animal Animal / lab evidence | Not reviewed |
| Regulatory | FDA-approved R1 · not on FDA's 503A or 503B bulk-substance category lists and not on FDA's compounding safety-risk page R4, R5, R6 · not named by WADA R7 |
| Established human dose | Yes, label dose (see Study details) |
Evidence verdict: Multiple myeloma and mantle cell lymphoma: Strong (phase 3 RCT)
This page reports what studies used. It is not dosing advice.
Legend: HUMAN data · ANIMAL / LAB data · UNKNOWN · UNVERIFIED: not yet confirmed against a primary source
About the evidence: a large randomized phase 3 trial that established it as a standard myeloma therapy.
What is it?
Related pages: carfilzomib, romidepsin.
Does it work?
- Human Response 38% vs 18%; time to progression 6.2 vs 3.5 months. R3
Is it safe?
- Human Grade 3/4 events 75% vs 60%. R3
- Label: neuropathy; contraindicated intrathecally. R2
Gray-market vials: extra risks
A gray-market vial has no quality control and no guarantee of identity, strength or sterility. We test retail vials blind under the Open Peptide Standard; see /tests/. A passing test covers one batch on one date and does not mean the compound is safe.
Is it legal?
- US: FDA-approved, prescription; generics exist. R1 UNVERIFIED generic application numbers (not checked).
- Compounding: not on FDA's 503A or 503B bulk-substance category lists and not on FDA's compounding safety-risk page. R4, R5, R6
- Sport: not named on WADA's 2026 Prohibited List. R7
Study details
Study details
These are amounts researchers used, not recommendations.
| Study | People / model | Route | Amount used | Follow-up | Reported | Citation |
|---|---|---|---|---|---|---|
| APEX 2005 | 669 relapsed myeloma | IV | 1.3 mg/m² per study schedule | Per study | TTP 6.22 vs 3.49 months | PMID 15958804 |
Full reference list (PubMed, CT.gov, FDA and WADA checked Oct 27, 2026)
- R1 Drugs@FDA, Velcade (bortezomib), application NDA021602 (openFDA drugsfda record checked Oct 27, 2026). https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=NDA021602
- R2 Velcade prescribing information, label published Aug 28, 2025 (DailyMed, checked Oct 27, 2026). https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=1521d321-e724-4ffc-adad-34bf4f44fac7
- R3 Richardson PG, et al. N Engl J Med. 2005. PMID 15958804
- R4 FDA, 503A bulk drug substances categories list (updated May 14, 2026). https://www.fda.gov/media/94155/download
- R5 FDA, 503B bulk drug substances categories list (updated Mar 21, 2025). https://www.fda.gov/media/94164/download
- R6 FDA, Certain bulk drug substances for use in compounding that may present significant safety risks (content current Apr 22, 2026). https://www.fda.gov/drugs/human-drug-compounding/certain-bulk-drug-substances-use-compounding-may-present-significant-safety-risks
- R7 WADA. The 2026 Prohibited List, full list checked; compound not named. https://www.wada-ama.org/sites/default/files/2025-09/2026list_en_final_clean_september_2025.pdf
Disclaimer
This page is for education and harm reduction, not medical advice or a recommendation to use Bortezomib (Velcade, PS-341). This is a prescription medicine. Use it only under the care of a licensed clinician; do not buy it from research-chemical or gray-market sellers. Report problems to FDA MedWatch (https://www.fda.gov/safety/medwatch).