Last reviewed 2026-05-30 · How we verify

Tuberactinomycin N (ENVIOMYCIN)

Phase 2 active Recombinant protein Under review Quality 24/100

Tuberactinomycin N (generic name: ENVIOMYCIN) is a enviomycin drug. It is currently in Phase 2 development for Pulmonary tuberculosis.

Enviomycin works by inhibiting bacterial growth and replication.

Tuberactinomycin N is a protein modality. It is being studied in an exploratory clinical trial for the treatment of pulmonary multidrug-resistant tuberculosis (MDR-TB) in Japanese participants.

Likelihood of approval

17.3% 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).
Anti-infectives pathway favourability +2.0pp
Microbiological endpoints + non-inferiority designs raise approval rates above baseline.

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	ENVIOMYCIN
Drug class	enviomycin
Modality	Recombinant protein
Therapeutic area	Infectious Disease
Phase	Phase 2

Mechanism of action

Imagine your body's cells are under attack by bacteria. Enviomycin is like a special tool that helps stop the bacteria from multiplying and causing harm. It does this by interfering with the bacteria's ability to grow and divide.

Approved indications

Pulmonary tuberculosis

Common side effects

No common side effects on file.

Key clinical trials

An Exploratory Study of TMC207 in Japanese Participants With Pulmonary Multi-Drug Resistant Tuberculosis (MDR-TB) (PHASE2)

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:

Tuberactinomycin N CI brief — competitive landscape report
Tuberactinomycin N updates RSS · CI watch RSS

Frequently asked questions about Tuberactinomycin N

What is Tuberactinomycin N?

Tuberactinomycin N (ENVIOMYCIN) is a enviomycin drug, indicated for Pulmonary tuberculosis.

How does Tuberactinomycin N work?

Enviomycin works by inhibiting bacterial growth and replication.

What is Tuberactinomycin N used for?

Tuberactinomycin N is indicated for Pulmonary tuberculosis.

What is the generic name of Tuberactinomycin N?

ENVIOMYCIN is the generic (nonproprietary) name of Tuberactinomycin N.

What drug class is Tuberactinomycin N in?

Tuberactinomycin N belongs to the enviomycin class. See all enviomycin drugs at /class/enviomycin.

What development phase is Tuberactinomycin N in?

Tuberactinomycin N is in Phase 2.

Drug class: All enviomycin drugs
Therapeutic area: All drugs in Infectious Disease
Indication: Drugs for Pulmonary tuberculosis

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