Last reviewed 2026-05-19 · How we verify

Passiflora, Crataegus e Salix

Ativus Farmaceutica Ltda · Phase 3 active Small molecule ✓ Verified May 2026

Passiflora, Crataegus e Salix is a Herbal combination / Phytotherapeutic Small molecule drug developed by Ativus Farmaceutica Ltda. It is currently in Phase 3 development for Anxiety and nervous tension, Cardiovascular support and mild heart palpitations.

This herbal combination product works through the synergistic anxiolytic, cardiotonic, and anti-inflammatory properties of its three plant constituents to promote cardiovascular and nervous system health.

Passiflora and the combination of Crataegus and Salix have been studied in clinical trials for their efficacy and tolerability in treating mild and moderate anxiety. The mechanism of action for these substances is currently unknown.

Likelihood of approval

55.3% 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).
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	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	Passiflora, Crataegus e Salix
Sponsor	Ativus Farmaceutica Ltda
Drug class	Herbal combination / Phytotherapeutic
Modality	Small molecule
Therapeutic area	Cardiovascular / Psychiatry
Phase	Phase 3

Mechanism of action

Passiflora (passionflower) acts as a mild anxiolytic and sedative through GABA receptor modulation. Crataegus (hawthorn) provides cardiotonic effects by improving cardiac contractility and coronary blood flow. Salix (willow bark) contributes anti-inflammatory and analgesic activity through salicylate compounds. Together, these botanicals are traditionally used to support cardiovascular function and emotional well-being.

Approved indications

Anxiety and nervous tension
Cardiovascular support and mild heart palpitations

Common side effects

Gastrointestinal upset
Headache
Dizziness
Allergic reactions (rare)

Key clinical trials

Efficacy and Tolerability Study to Treat Mild and Moderate Anxiety (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:

Passiflora, Crataegus e Salix CI brief — competitive landscape report
Passiflora, Crataegus e Salix updates RSS · CI watch RSS
Ativus Farmaceutica Ltda portfolio CI

Frequently asked questions about Passiflora, Crataegus e Salix

What is Passiflora, Crataegus e Salix?

Passiflora, Crataegus e Salix is a Herbal combination / Phytotherapeutic drug developed by Ativus Farmaceutica Ltda, indicated for Anxiety and nervous tension, Cardiovascular support and mild heart palpitations.

How does Passiflora, Crataegus e Salix work?

What is Passiflora, Crataegus e Salix used for?

Passiflora, Crataegus e Salix is indicated for Anxiety and nervous tension, Cardiovascular support and mild heart palpitations.

Who makes Passiflora, Crataegus e Salix?

Passiflora, Crataegus e Salix is developed by Ativus Farmaceutica Ltda (see full Ativus Farmaceutica Ltda pipeline at /company/ativus-farmaceutica-ltda).

What drug class is Passiflora, Crataegus e Salix in?

Passiflora, Crataegus e Salix belongs to the Herbal combination / Phytotherapeutic class. See all Herbal combination / Phytotherapeutic drugs at /class/herbal-combination-phytotherapeutic.

What development phase is Passiflora, Crataegus e Salix in?

Passiflora, Crataegus e Salix is in Phase 3.

What are the side effects of Passiflora, Crataegus e Salix?

Common side effects of Passiflora, Crataegus e Salix include Gastrointestinal upset, Headache, Dizziness, Allergic reactions (rare).

Drug class: All Herbal combination / Phytotherapeutic drugs
Manufacturer: Ativus Farmaceutica Ltda — full pipeline
Therapeutic area: All drugs in Cardiovascular / Psychiatry
Indication: Drugs for Anxiety and nervous tension
Indication: Drugs for Cardiovascular support and mild heart palpitations

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