Last reviewed 2026-04-20 · How we verify

Doxylamine Succinate USP

Nawaz Sharif Medical College · Phase 1 active Small molecule Quality 0/100

Doxylamine Succinate USP is a Small molecule drug developed by Nawaz Sharif Medical College. It is currently in Phase 1 development. Also known as: Doxylamine Succinate United States Pharmacopeia (USP).

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	Doxylamine Succinate USP
Also known as	Doxylamine Succinate United States Pharmacopeia (USP)
Sponsor	Nawaz Sharif Medical College
Modality	Small molecule
Phase	Phase 1

Approved indications

No approved indications tracked.

Common side effects

Diarrhoea
Nausea

Competitive intelligence

For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:

Doxylamine Succinate USP CI brief — competitive landscape report
Doxylamine Succinate USP updates RSS · CI watch RSS
Nawaz Sharif Medical College portfolio CI

Frequently asked questions about Doxylamine Succinate USP

What is Doxylamine Succinate USP?

Doxylamine Succinate USP is a Small molecule drug developed by Nawaz Sharif Medical College.

Who makes Doxylamine Succinate USP?

Doxylamine Succinate USP is developed by Nawaz Sharif Medical College (see full Nawaz Sharif Medical College pipeline at /company/nawaz-sharif-medical-college).

Is Doxylamine Succinate USP also known as anything else?

Doxylamine Succinate USP is also known as Doxylamine Succinate United States Pharmacopeia (USP).

What development phase is Doxylamine Succinate USP in?

Doxylamine Succinate USP is in Phase 1.

What are the side effects of Doxylamine Succinate USP?

Common side effects of Doxylamine Succinate USP include Diarrhoea, Nausea.

Manufacturer: Nawaz Sharif Medical College — full pipeline
Also known as: Doxylamine Succinate United States Pharmacopeia (USP)

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