Last reviewed 2026-06-02 · How we verify

quinacrine dihydrochloride - Extension dose

Neelesh Sharma MD PhD · Phase 1 active Small molecule ✓ Verified Jun 2026

quinacrine dihydrochloride - Extension dose is a Small molecule drug developed by Neelesh Sharma MD PhD. It is currently in Phase 1 development. Also known as: atabrine dihydrochloride, mepacrine dihydrochoride, SN 390.

Quinacrine dihydrochloride is being studied in combination with erlotinib hydrochloride for the treatment of Stage IIIB and Stage IV Non-small Cell Lung Cancer. The study involves an escalation dose of quinacrine dihydrochloride in combination with erlotinib hydrochloride.

Likelihood of approval

9.6% vs 9.6% industry baseline

If approved by FDA: likely 2033–2036

Steps remaining: Phase 2 → Phase 3 → NDA/BLA submission

Confidence: Medium

Why this estimate

Baseline phase 1 → approval rate +9.6pp
Industry-wide phase 1 drugs reach approval ~9.6% 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	2033–2036	—
EMA	EU	2034–2037	+0.7 yr
MHRA	GB	2034–2037	+0.7 yr
Health Canada	CA	2034–2038	+0.9 yr
TGA	AU	2034–2038	+1.2 yr
PMDA	JP	2034–2038	+1.5 yr
NMPA	CN	2035–2039	+2.3 yr
MFDS	KR	2034–2038	+1.4 yr
CDSCO	IN	2034–2039	+1.8 yr
ANVISA	BR	2035–2039	+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	quinacrine dihydrochloride - Extension dose
Also known as	atabrine dihydrochloride, mepacrine dihydrochoride, SN 390
Sponsor	Neelesh Sharma MD PhD
Modality	Small molecule
Phase	Phase 1

Approved indications

No approved indications tracked.

Common side effects

No common side effects on file.

Key clinical trials

Erlotinib Hydrochloride and Quinacrine Dihydrochloride in Stage IIIB-IV Non-Small Cell Lung Cancer (PHASE1)

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:

quinacrine dihydrochloride - Extension dose CI brief — competitive landscape report
quinacrine dihydrochloride - Extension dose updates RSS · CI watch RSS
Neelesh Sharma MD PhD portfolio CI

Frequently asked questions about quinacrine dihydrochloride - Extension dose

What is quinacrine dihydrochloride - Extension dose?

quinacrine dihydrochloride - Extension dose is a Small molecule drug developed by Neelesh Sharma MD PhD.

Who makes quinacrine dihydrochloride - Extension dose?

quinacrine dihydrochloride - Extension dose is developed by Neelesh Sharma MD PhD (see full Neelesh Sharma MD PhD pipeline at /company/neelesh-sharma-md-phd).

Is quinacrine dihydrochloride - Extension dose also known as anything else?

quinacrine dihydrochloride - Extension dose is also known as atabrine dihydrochloride, mepacrine dihydrochoride, SN 390.

What development phase is quinacrine dihydrochloride - Extension dose in?

quinacrine dihydrochloride - Extension dose is in Phase 1.

Manufacturer: Neelesh Sharma MD PhD — full pipeline
Also known as: atabrine dihydrochloride, mepacrine dihydrochoride, SN 390

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