Last reviewed 2026-04-20 · How we verify

Phenglutarimid (PHENGLUTARIMIDE)

Phase 2 active Small molecule

Phenglutarimid (generic name: PHENGLUTARIMIDE) is a phenglutarimide drug. It is currently in Phase 2 development.

Phenglutarimide is thought to work by interacting with a specific biological target, but its exact mechanism is not yet understood.

Phenglutarimide is a small molecule drug of the phenglutarimide class, but its target and mechanism of action are unknown. Its commercial status and approved indications are also unclear. As a result, key safety considerations and pharmacokinetic properties such as half-life and bioavailability are not well established. Further research is needed to fully understand this compound. Its current owner and development history are also unknown.

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	PHENGLUTARIMIDE
Drug class	phenglutarimide
Modality	Small molecule
Therapeutic area	Other
Phase	Phase 2

Mechanism of action

Imagine your body's cells are like locks, and phenglutarimide is a key that fits into one of those locks. When it binds to the lock, it can either turn it on or off, or change how it works. But since we don't know what lock it's meant to fit into, we can't be sure how it will affect the body.

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:

Phenglutarimid CI brief — competitive landscape report
Phenglutarimid updates RSS · CI watch RSS

Frequently asked questions about Phenglutarimid

What is Phenglutarimid?

Phenglutarimid (PHENGLUTARIMIDE) is a phenglutarimide drug.

How does Phenglutarimid work?

Phenglutarimide is thought to work by interacting with a specific biological target, but its exact mechanism is not yet understood.

What is the generic name of Phenglutarimid?

PHENGLUTARIMIDE is the generic (nonproprietary) name of Phenglutarimid.

What drug class is Phenglutarimid in?

Phenglutarimid belongs to the phenglutarimide class. See all phenglutarimide drugs at /class/phenglutarimide.

What development phase is Phenglutarimid in?

Phenglutarimid is in Phase 2.

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

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