Last reviewed 2026-05-22 · How we verify

Vilazadone

Forest Laboratories · Phase 3 active Small molecule ✓ Verified May 2026 Quality 10/100

Vilazadone is a Small molecule drug developed by Forest Laboratories. It is currently in Phase 3 development. Also known as: Vilazadone once per day, 20 mg dose, oral administration or Vilazadone once per day, 40 mg dose, oral administration..

Vilazadone is being studied for its safety, efficacy, and tolerability in patients with Generalized Anxiety Disorder. It is being compared to a placebo in a double-blind, flexible-dose study.

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	Vilazadone
Also known as	Vilazadone once per day, 20 mg dose, oral administration or Vilazadone once per day, 40 mg dose, oral administration.
Sponsor	Forest Laboratories
Modality	Small molecule
Therapeutic area	Other
Phase	Phase 3

Approved indications

No approved indications tracked.

Common side effects

Diarrhoea
Headache
Nausea
Dizziness
Dry mouth
Upper respiratory tract infection
Somnolence
Abnormal dreams
Vomiting

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:

Vilazadone CI brief — competitive landscape report
Vilazadone updates RSS · CI watch RSS
Forest Laboratories portfolio CI

Frequently asked questions about Vilazadone

What is Vilazadone?

Vilazadone is a Small molecule drug developed by Forest Laboratories.

Who makes Vilazadone?

Vilazadone is developed by Forest Laboratories (see full Forest Laboratories pipeline at /company/forest-laboratories).

Is Vilazadone also known as anything else?

Vilazadone is also known as Vilazadone once per day, 20 mg dose, oral administration or Vilazadone once per day, 40 mg dose, oral administration..

What development phase is Vilazadone in?

Vilazadone is in Phase 3.

What are the side effects of Vilazadone?

Common side effects of Vilazadone include Diarrhoea, Headache, Nausea, Dizziness, Dry mouth, Upper respiratory tract infection.

Manufacturer: Forest Laboratories — full pipeline
Therapeutic area: All drugs in Other
Also known as: Vilazadone once per day, 20 mg dose, oral administration or Vilazadone once per day, 40 mg dose, oral administration.

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