Last reviewed 2026-05-22 · How we verify

Distamycin 3 (STALLIMYCIN)

Phase 2 active Small molecule ✓ Verified May 2026

Distamycin 3 (generic name: STALLIMYCIN) is a stallimycin drug. It is currently in Phase 2 development.

Distamycin 3 works by binding to the estrogen receptor, disrupting its interaction with estrogen and potentially inhibiting its activity.

Distamycin 3 is a small molecule with the synonyms Distamycin A Hydrochloride, Herpera, and Herperal. Its exact mechanism and indications are not specified in the provided facts, but it is classified as a small molecule.

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	STALLIMYCIN
Drug class	stallimycin
Target	GTPase HRas, DNA topoisomerase 1, Estrogen receptor
Modality	Small molecule
Therapeutic area	Other
Phase	Phase 2

Mechanism of action

Imagine the estrogen receptor as a key that unlocks a door. Estrogen is like the key that fits perfectly into the lock, allowing it to turn and open the door. Distamycin 3 is like a different key that doesn't fit perfectly, making it harder for the estrogen key to turn the lock and open the door.

Approved indications

No approved indications tracked.

Common side effects

No common side effects on file.

Competitive intelligence

For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:

Distamycin 3 CI brief — competitive landscape report
Distamycin 3 updates RSS · CI watch RSS

Frequently asked questions about Distamycin 3

What is Distamycin 3?

Distamycin 3 (STALLIMYCIN) is a stallimycin drug.

How does Distamycin 3 work?

Distamycin 3 works by binding to the estrogen receptor, disrupting its interaction with estrogen and potentially inhibiting its activity.

What is the generic name of Distamycin 3?

STALLIMYCIN is the generic (nonproprietary) name of Distamycin 3.

What drug class is Distamycin 3 in?

Distamycin 3 belongs to the stallimycin class. See all stallimycin drugs at /class/stallimycin.

What development phase is Distamycin 3 in?

Distamycin 3 is in Phase 2.

What does Distamycin 3 target?

Distamycin 3 targets GTPase HRas, DNA topoisomerase 1, Estrogen receptor and is a stallimycin.

Drug class: All stallimycin drugs
Target: All drugs targeting GTPase HRas, DNA topoisomerase 1, Estrogen receptor
Therapeutic area: All drugs in Other

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