Last reviewed 2026-04-23 · How we verify

flibanserin flexible dose

Sprout Pharmaceuticals, Inc · Phase 3 active Small molecule

flibanserin flexible dose is a Serotonin 5-HT1A receptor agonist / 5-HT2A receptor antagonist Small molecule drug developed by Sprout Pharmaceuticals, Inc. It is currently in Phase 3 development for Hypoactive sexual desire disorder (HSDD) in premenopausal women.

Flibanserin is a serotonin 5-HT1A receptor agonist and 5-HT2A receptor antagonist that modulates neurotransmitter activity in the brain to increase sexual desire.

Flibanserin is a serotonin 5-HT1A receptor agonist and 5-HT2A receptor antagonist that modulates neurotransmitter activity in the brain to increase sexual desire. Used for Hypoactive sexual desire disorder (HSDD) in premenopausal women.

Likelihood of approval

58.3% vs 58.3% industry baseline

If approved by FDA: likely 2028–2030

Steps remaining: NDA/BLA submission

Confidence: High

Why this estimate

Baseline phase 3 → approval rate +58.3pp
Industry-wide phase 3 drugs reach approval ~58.3% 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	2028–2030	—
EMA	EU	2029–2031	+0.7 yr
MHRA	GB	2029–2031	+0.7 yr
Health Canada	CA	2029–2032	+0.9 yr
TGA	AU	2029–2032	+1.2 yr
PMDA	JP	2029–2032	+1.5 yr
NMPA	CN	2030–2033	+2.3 yr
MFDS	KR	2029–2032	+1.4 yr
CDSCO	IN	2029–2033	+1.8 yr
ANVISA	BR	2030–2033	+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	flibanserin flexible dose
Sponsor	Sprout Pharmaceuticals, Inc
Drug class	Serotonin 5-HT1A receptor agonist / 5-HT2A receptor antagonist
Target	5-HT1A receptor (agonist), 5-HT2A receptor (antagonist)
Modality	Small molecule
Therapeutic area	Sexual Health / Women's Health
Phase	Phase 3

Mechanism of action

Flibanserin works by increasing dopamine and norepinephrine while decreasing serotonin in key brain regions involved in sexual motivation and desire. The drug's agonist activity at 5-HT1A receptors and antagonist activity at 5-HT2A receptors together produce a net effect of enhancing sexual motivation and arousal. This mechanism addresses the neurobiological basis of hypoactive sexual desire disorder (HSDD) in women.

Approved indications

Hypoactive sexual desire disorder (HSDD) in premenopausal women

Common side effects

Dizziness
Nausea
Fatigue
Somnolence
Dry mouth
Hypotension

Key clinical trials

Flibanserin Evaluation Over 28 Additional Weeks in Hypoactive Sexual Desire Disorder (PHASE3)

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:

flibanserin flexible dose CI brief — competitive landscape report
flibanserin flexible dose updates RSS · CI watch RSS
Sprout Pharmaceuticals, Inc portfolio CI

Frequently asked questions about flibanserin flexible dose

What is flibanserin flexible dose?

flibanserin flexible dose is a Serotonin 5-HT1A receptor agonist / 5-HT2A receptor antagonist drug developed by Sprout Pharmaceuticals, Inc, indicated for Hypoactive sexual desire disorder (HSDD) in premenopausal women.

How does flibanserin flexible dose work?

Flibanserin is a serotonin 5-HT1A receptor agonist and 5-HT2A receptor antagonist that modulates neurotransmitter activity in the brain to increase sexual desire.

What is flibanserin flexible dose used for?

flibanserin flexible dose is indicated for Hypoactive sexual desire disorder (HSDD) in premenopausal women.

Who makes flibanserin flexible dose?

flibanserin flexible dose is developed by Sprout Pharmaceuticals, Inc (see full Sprout Pharmaceuticals, Inc pipeline at /company/sprout-pharmaceuticals-inc).

What drug class is flibanserin flexible dose in?

flibanserin flexible dose belongs to the Serotonin 5-HT1A receptor agonist / 5-HT2A receptor antagonist class. See all Serotonin 5-HT1A receptor agonist / 5-HT2A receptor antagonist drugs at /class/serotonin-5-ht1a-receptor-agonist-5-ht2a-receptor-antagonist.

What development phase is flibanserin flexible dose in?

flibanserin flexible dose is in Phase 3.

What are the side effects of flibanserin flexible dose?

Common side effects of flibanserin flexible dose include Dizziness, Nausea, Fatigue, Somnolence, Dry mouth, Hypotension.

What does flibanserin flexible dose target?

flibanserin flexible dose targets 5-HT1A receptor (agonist), 5-HT2A receptor (antagonist) and is a Serotonin 5-HT1A receptor agonist / 5-HT2A receptor antagonist.

Drug class: All Serotonin 5-HT1A receptor agonist / 5-HT2A receptor antagonist drugs
Target: All drugs targeting 5-HT1A receptor (agonist), 5-HT2A receptor (antagonist)
Manufacturer: Sprout Pharmaceuticals, Inc — full pipeline
Therapeutic area: All drugs in Sexual Health / Women's Health
Indication: Drugs for Hypoactive sexual desire disorder (HSDD) in premenopausal women

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