Last reviewed 2026-05-24 · How we verify

Diphacil (ADIPHENINE)

Phase 2 active Small molecule ✓ Verified May 2026

Diphacil (generic name: ADIPHENINE) is a adiphenine drug. It is currently in Phase 2 development.

Diphacil is believed to work by modulating certain physiological processes.

Diphacil, also known as Adiphenine, is a small molecule drug in the adiphenine class. Its exact target and mechanism of action are unknown, but it is believed to work by modulating certain physiological processes. Diphacil's commercial status and approved indications are unclear, and it is not known whether it is patented or available as a generic medication. Further research is needed to fully understand its properties and potential uses. As a result, key safety considerations and pharmacokinetic parameters, such as half-life and bioavailability, are also unknown.

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	ADIPHENINE
Drug class	adiphenine
Target	Histamine H1 receptor, Muscarinic acetylcholine receptor
Modality	Small molecule
Therapeutic area	Other
Phase	Phase 2

Mechanism of action

Think of Diphacil like a key that unlocks a specific process in the body. When it binds to its target, it can either turn the process up or down, depending on what's needed. This can help restore balance to the body's systems 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:

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

Frequently asked questions about Diphacil

What is Diphacil?

Diphacil (ADIPHENINE) is a adiphenine drug.

How does Diphacil work?

Diphacil is believed to work by modulating certain physiological processes.

What is the generic name of Diphacil?

ADIPHENINE is the generic (nonproprietary) name of Diphacil.

What drug class is Diphacil in?

Diphacil belongs to the adiphenine class. See all adiphenine drugs at /class/adiphenine.

What development phase is Diphacil in?

Diphacil is in Phase 2.

What does Diphacil target?

Diphacil targets Histamine H1 receptor, Muscarinic acetylcholine receptor and is a adiphenine.

Drug class: All adiphenine drugs
Target: All drugs targeting Histamine H1 receptor, Muscarinic acetylcholine receptor
Therapeutic area: All drugs in Other

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