Last reviewed 2026-04-20 · How we verify

Pizotyline (Pizotifen)

Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh · Phase 2 active Small molecule

Pizotyline (generic name: Pizotifen) is a pizotifen Small molecule drug developed by Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh. It is currently in Phase 2 development.

Pizotyline works by binding to and blocking the 5-hydroxytryptamine receptor 2C, which is involved in serotonin signaling.

Pizotyline, also known as Pizotifen, is a small molecule drug that targets the 5-hydroxytryptamine receptor 2C. It is developed and owned by Bangabandhu Sheikh Mujib Medical University in Bangladesh. The exact indications and commercial status of Pizotyline are unknown. As a pizotifen drug, it is likely used to treat conditions related to serotonin receptor modulation. Further research is needed to determine its safety profile and potential side effects.

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	Pizotifen
Sponsor	Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
Drug class	pizotifen
Target	5-hydroxytryptamine receptor 1A, 5-hydroxytryptamine receptor 2A, 5-hydroxytryptamine receptor 2B
Modality	Small molecule
Therapeutic area	Other
Phase	Phase 2

Mechanism of action

Imagine your brain has a messaging system that uses serotonin as a key player. Pizotyline blocks one of the receptors that serotonin attaches to, which can help regulate the flow of serotonin signals and potentially treat conditions related to serotonin imbalance.

Approved indications

No approved indications tracked.

Common side effects

Vestibular migraine
Clonus
Hyperreflexia
Therapeutic response changed
Endometrial cancer
Muscle twitching

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:

Pizotyline CI brief — competitive landscape report
Pizotyline updates RSS · CI watch RSS
Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh portfolio CI

Frequently asked questions about Pizotyline

What is Pizotyline?

Pizotyline (Pizotifen) is a pizotifen drug developed by Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh.

How does Pizotyline work?

Pizotyline works by binding to and blocking the 5-hydroxytryptamine receptor 2C, which is involved in serotonin signaling.

Who makes Pizotyline?

Pizotyline is developed by Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh (see full Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh pipeline at /company/bangabandhu-sheikh-mujib-medical-university-dhaka-bangladesh).

What is the generic name of Pizotyline?

Pizotifen is the generic (nonproprietary) name of Pizotyline.

What drug class is Pizotyline in?

Pizotyline belongs to the pizotifen class. See all pizotifen drugs at /class/pizotifen.

What development phase is Pizotyline in?

Pizotyline is in Phase 2.

What are the side effects of Pizotyline?

Common side effects of Pizotyline include Vestibular migraine, Clonus, Hyperreflexia, Therapeutic response changed, Endometrial cancer, Muscle twitching.

What does Pizotyline target?

Pizotyline targets 5-hydroxytryptamine receptor 1A, 5-hydroxytryptamine receptor 2A, 5-hydroxytryptamine receptor 2B and is a pizotifen.

Drug class: All pizotifen drugs
Target: All drugs targeting 5-hydroxytryptamine receptor 1A, 5-hydroxytryptamine receptor 2A, 5-hydroxytryptamine receptor 2B
Manufacturer: Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh — full pipeline
Therapeutic area: All drugs in Other

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