Last reviewed 2026-05-14 · How we verify

DFN-15 Dose 1

Dr. Reddy's Laboratories Limited · Phase 2 active Small molecule

DFN-15 Dose 1 is a 5-HT7 receptor antagonist Small molecule drug developed by Dr. Reddy's Laboratories Limited. It is currently in Phase 2 development for Major depressive disorder with sleep disturbance. Also known as: Celecoxib.

DFN-15 is a selective serotonin 5-HT7 receptor antagonist designed to modulate serotonergic neurotransmission.

DFN-15 is a selective serotonin 5-HT7 receptor antagonist designed to modulate serotonergic neurotransmission. Used for Major depressive disorder with sleep disturbance.

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	DFN-15 Dose 1
Also known as	Celecoxib
Sponsor	Dr. Reddy's Laboratories Limited
Drug class	5-HT7 receptor antagonist
Target	5-HT7 receptor
Modality	Small molecule
Therapeutic area	Psychiatry/Neurology
Phase	Phase 2

Mechanism of action

DFN-15 targets the 5-HT7 receptor, a G-protein coupled receptor involved in circadian rhythm regulation and mood modulation. By antagonizing this receptor, the drug aims to restore normal sleep-wake cycles and improve mood symptoms. This mechanism is distinct from traditional antidepressants and may offer a novel approach to treating sleep and mood disorders.

Approved indications

Major depressive disorder with sleep disturbance

Common side effects

Headache
Nausea
Dizziness
Insomnia

Key clinical trials

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:

DFN-15 Dose 1 CI brief — competitive landscape report
DFN-15 Dose 1 updates RSS · CI watch RSS
Dr. Reddy's Laboratories Limited portfolio CI

Frequently asked questions about DFN-15 Dose 1

What is DFN-15 Dose 1?

DFN-15 Dose 1 is a 5-HT7 receptor antagonist drug developed by Dr. Reddy's Laboratories Limited, indicated for Major depressive disorder with sleep disturbance.

How does DFN-15 Dose 1 work?

DFN-15 is a selective serotonin 5-HT7 receptor antagonist designed to modulate serotonergic neurotransmission.

What is DFN-15 Dose 1 used for?

DFN-15 Dose 1 is indicated for Major depressive disorder with sleep disturbance.

Who makes DFN-15 Dose 1?

DFN-15 Dose 1 is developed by Dr. Reddy's Laboratories Limited (see full Dr. Reddy's Laboratories Limited pipeline at /company/dr-reddy-s-laboratories-limited).

Is DFN-15 Dose 1 also known as anything else?

DFN-15 Dose 1 is also known as Celecoxib.

What drug class is DFN-15 Dose 1 in?

DFN-15 Dose 1 belongs to the 5-HT7 receptor antagonist class. See all 5-HT7 receptor antagonist drugs at /class/5-ht7-receptor-antagonist.

What development phase is DFN-15 Dose 1 in?

DFN-15 Dose 1 is in Phase 2.

What are the side effects of DFN-15 Dose 1?

Common side effects of DFN-15 Dose 1 include Headache, Nausea, Dizziness, Insomnia.

What does DFN-15 Dose 1 target?

DFN-15 Dose 1 targets 5-HT7 receptor and is a 5-HT7 receptor antagonist.

Drug class: All 5-HT7 receptor antagonist drugs
Target: All drugs targeting 5-HT7 receptor
Manufacturer: Dr. Reddy's Laboratories Limited — full pipeline
Therapeutic area: All drugs in Psychiatry/Neurology
Indication: Drugs for Major depressive disorder with sleep disturbance
Also known as: Celecoxib

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