Last reviewed 2026-04-20 · How we verify

Pantocalcin (HOPANTENIC ACID)

Phase 2 active Small molecule

Pantocalcin (generic name: HOPANTENIC ACID) is a drug. It is currently in Phase 2 development.

Pantocalcin works by modulating neurotransmitter activity in the brain.

Pantocalcin, also known as Hopantenic Acid, is a small molecule drug with unknown target and drug class. Its commercial status is unclear, and it is not known if it is FDA approved or off-patent. The approved indications for Pantocalcin are also unknown. As a small molecule, it is likely to be administered orally, but its pharmacokinetic properties such as half-life and bioavailability are not well-documented. Further research is needed to understand the safety and efficacy of Pantocalcin.

Likelihood of approval

12.3% 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).
CNS / neurology attrition -3.0pp
CNS drugs have historically high Phase 3 failure rates (notably in Alzheimer disease + major depression).

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	HOPANTENIC ACID
Modality	Small molecule
Therapeutic area	Neuroscience
Phase	Phase 2

Mechanism of action

Imagine your brain is a busy city with many different streets and intersections. Pantocalcin helps to regulate the flow of traffic by influencing the signals that control the movement of neurotransmitters, which are like the cars on the road. This can help to improve communication between different parts of the brain and alleviate symptoms of certain conditions.

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:

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

Frequently asked questions about Pantocalcin

What is Pantocalcin?

Pantocalcin (HOPANTENIC ACID) is a Small molecule drug.

How does Pantocalcin work?

Pantocalcin works by modulating neurotransmitter activity in the brain.

What is the generic name of Pantocalcin?

HOPANTENIC ACID is the generic (nonproprietary) name of Pantocalcin.

What development phase is Pantocalcin in?

Pantocalcin is in Phase 2.

Therapeutic area: All drugs in Neuroscience

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