Evidence review: Open Peptide Project (verified against primary PubMed, ClinicalTrials.gov & FDA records) · Last checked 2026-10-27. ← Back to Evidence Library
Carfilzomib (Kyprolis, PR-171): what the evidence says
At a glance
What it is: a modified tetrapeptide (epoxyketone) that irreversibly blocks the proteasome. Approved as Kyprolis in Jul 2012 for relapsed or refractory multiple myeloma, in several combinations. R1, R2
What the evidence says: Human in ASPIRE (792 patients), adding carfilzomib to lenalidomide and dexamethasone improved progression-free survival and 24-month survival (73% vs 65%). R3
Biggest risks: label warnings include heart failure and ischemia, kidney failure, lung toxicity, pulmonary hypertension and thrombotic microangiopathy. R2
Rating
| Human Human evidence | Strong: ASPIRE RCT (n = 792) 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: Relapsed multiple myeloma: Strong (phase 3 RCT, n = 792)
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. This is a chemotherapy-ward drug.
What is it?
Related pages: bortezomib, romidepsin.
Does it work?
- Human Response 87.1% vs 66.7%; 24-month survival 73.3% vs 65.0%. R3
Is it safe?
- Human Grade ≥3 events 83.7% vs 80.7%. R3
- Label cardiac and renal warnings. 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. R1
- 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 |
|---|---|---|---|---|---|---|
| ASPIRE 2015 | 792 relapsed myeloma | IV | Per study | Median follow-up per study | PFS improved; OS HR 0.79 | PMID 25482145 |
Full reference list (PubMed, CT.gov, FDA and WADA checked Oct 27, 2026)
- R1 Drugs@FDA, Kyprolis (carfilzomib), application NDA202714 (openFDA drugsfda record checked Oct 27, 2026). https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=NDA202714
- R2 Kyprolis prescribing information, label published Jun 18, 2025 (DailyMed, checked Oct 27, 2026). https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=ea66eb30-e665-4693-99a1-a9d3b4bbe2d6
- R3 Stewart AK, et al. N Engl J Med. 2015. PMID 25482145
- 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 Carfilzomib (Kyprolis, PR-171). 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).