Last reviewed 2026-04-20 · How we verify

Bleomycin Pep (PEPLOMYCIN)

Phase 2 active Small molecule

Bleomycin Pep (generic name: PEPLOMYCIN) is a peplomycin drug. It is currently in Phase 2 development.

Peplomycin works by binding to DNA and inhibiting the synthesis of DNA and RNA, ultimately leading to cell death.

Bleomycin Pep, also known as Peplomycin, is a peplomycin class small molecule drug. Its exact target is unknown, but it is used to treat certain types of cancer. The commercial status of Peplomycin is unclear, and it may be patented or have generic manufacturers. Key safety considerations include its potential to cause pulmonary toxicity. Further research is needed to fully understand its pharmacokinetics and clinical applications.

Likelihood of approval

15.3% vs 15.3% industry baseline

If approved by FDA: likely 2031–2034

Steps remaining: Phase 3 → NDA/BLA submission

Confidence: Medium

Why this estimate

Baseline phase 2 → approval rate +15.3pp
Industry-wide phase 2 drugs reach approval ~15.3% 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	2031–2034	—
EMA	EU	2032–2035	+0.7 yr
MHRA	GB	2032–2035	+0.7 yr
Health Canada	CA	2032–2036	+0.9 yr
TGA	AU	2032–2036	+1.2 yr
PMDA	JP	2032–2036	+1.5 yr
NMPA	CN	2033–2037	+2.3 yr
MFDS	KR	2032–2036	+1.4 yr
CDSCO	IN	2032–2037	+1.8 yr
ANVISA	BR	2033–2037	+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	PEPLOMYCIN
Drug class	peplomycin
Modality	Small molecule
Therapeutic area	Other
Phase	Phase 2

Mechanism of action

Imagine your cells are like factories that make new parts. Peplomycin is like a machine that breaks down the factory's blueprint, making it impossible for the factory to produce new parts. This ultimately leads to the factory shutting down, or in this case, the cell dying.

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:

Bleomycin Pep CI brief — competitive landscape report
Bleomycin Pep updates RSS · CI watch RSS

Frequently asked questions about Bleomycin Pep

What is Bleomycin Pep?

Bleomycin Pep (PEPLOMYCIN) is a peplomycin drug.

How does Bleomycin Pep work?

Peplomycin works by binding to DNA and inhibiting the synthesis of DNA and RNA, ultimately leading to cell death.

What is the generic name of Bleomycin Pep?

PEPLOMYCIN is the generic (nonproprietary) name of Bleomycin Pep.

What drug class is Bleomycin Pep in?

Bleomycin Pep belongs to the peplomycin class. See all peplomycin drugs at /class/peplomycin.

What development phase is Bleomycin Pep in?

Bleomycin Pep is in Phase 2.

Drug class: All peplomycin drugs
Therapeutic area: All drugs in Other

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