Last reviewed 2026-04-19 · How we verify

IPROHEPTINE

Phase 2 active Small molecule

IPROHEPTINE is a drug. It is currently in Phase 2 development.

Iproheptine works by interacting with a specific molecular target to produce its therapeutic effects.

Iproheptine is a small molecule drug with unknown target and drug class. Its commercial status is unclear, and it has not been approved by the FDA for any indications. The drug's pharmacokinetic properties, including half-life and bioavailability, are also unknown. Iproheptine's safety profile and potential side effects are not well-documented. Further research is needed to understand its mechanism of action and potential therapeutic applications.

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	IPROHEPTINE
Modality	Small molecule
Therapeutic area	Other
Phase	Phase 2

Mechanism of action

Imagine your body's cells have locks on them, and the key to unlocking these locks is a specific molecule. Iproheptine is a small molecule that fits into these locks, allowing it to influence the behavior of the cells and produce its therapeutic effects. This process is known as binding to a molecular target, and it's a key way that many drugs work.

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:

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

Frequently asked questions about IPROHEPTINE

What is IPROHEPTINE?

IPROHEPTINE is a Small molecule drug.

How does IPROHEPTINE work?

Iproheptine works by interacting with a specific molecular target to produce its therapeutic effects.

What development phase is IPROHEPTINE in?

IPROHEPTINE is in Phase 2.

Therapeutic area: All drugs in Other

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