Last reviewed 2026-06-01 · How we verify

Arm I (Placebo),

Gangnam Severance Hospital · Phase 3 active Small molecule

Arm I (Placebo), is a Small molecule drug developed by Gangnam Severance Hospital. It is currently in Phase 3 development.

Placebo has no active pharmacological mechanism; it serves as a control comparator in clinical trials.

Likelihood of approval

58.3% vs 58.3% industry baseline

If approved by FDA: likely 2028–2030

Steps remaining: NDA/BLA submission

Confidence: High

Why this estimate

Baseline phase 3 → approval rate +58.3pp
Industry-wide phase 3 drugs reach approval ~58.3% 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	2028–2030	—
EMA	EU	2029–2031	+0.7 yr
MHRA	GB	2029–2031	+0.7 yr
Health Canada	CA	2029–2032	+0.9 yr
TGA	AU	2029–2032	+1.2 yr
PMDA	JP	2029–2032	+1.5 yr
NMPA	CN	2030–2033	+2.3 yr
MFDS	KR	2029–2032	+1.4 yr
CDSCO	IN	2029–2033	+1.8 yr
ANVISA	BR	2030–2033	+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	Arm I (Placebo),
Sponsor	Gangnam Severance Hospital
Modality	Small molecule
Phase	Phase 3

Mechanism of action

Placebo is an inert substance administered in blinded trials to establish baseline efficacy and safety of an investigational drug by comparison. Any observed effects are attributed to natural disease progression, regression to the mean, or the placebo effect itself. It is essential for determining whether observed outcomes in the active treatment arm exceed those expected from non-specific factors.

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:

Arm I (Placebo), CI brief — competitive landscape report
Arm I (Placebo), updates RSS · CI watch RSS
Gangnam Severance Hospital portfolio CI

Frequently asked questions about Arm I (Placebo),

What is Arm I (Placebo),?

Arm I (Placebo), is a Small molecule drug developed by Gangnam Severance Hospital.

How does Arm I (Placebo), work?

Placebo has no active pharmacological mechanism; it serves as a control comparator in clinical trials.

Who makes Arm I (Placebo),?

Arm I (Placebo), is developed by Gangnam Severance Hospital (see full Gangnam Severance Hospital pipeline at /company/gangnam-severance-hospital).

What development phase is Arm I (Placebo), in?

Arm I (Placebo), is in Phase 3.

Manufacturer: Gangnam Severance Hospital — full pipeline

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