Last reviewed 2026-05-25 · How we verify

Traumeel® / Zeel® Injectable Solution

Biologische Heilmittel Heel GmbH · Phase 3 active Small molecule Under review

Traumeel® / Zeel® Injectable Solution is a Homeopathic combination remedy Small molecule drug developed by Biologische Heilmittel Heel GmbH. It is currently in Phase 3 development for Traumatic injuries, contusions, and musculoskeletal trauma (Traumeel), Degenerative joint disease and osteoarthritis (Zeel), Rheumatoid arthritis and inflammatory joint conditions. Also known as: Traumeel, Zeel.

Traumeel and Zeel are homeopathic combination remedies that modulate inflammatory and immune responses through multiple plant and mineral constituents.

Traumeel/Zeel Injectable Solution is a treatment that has been studied in clinical trials for osteoarthritis of the knee. It has been tested in a multi-center, double-blind, randomized controlled trial as an intra-articular injection compared to a placebo.

Likelihood of approval

59.3% 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).
Immunology slight uplift +1.0pp
Mature endpoint landscape (ACR, DAS28, PASI) makes immunology approvals slightly more predictable.

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	Traumeel® / Zeel® Injectable Solution
Also known as	Traumeel, Zeel
Sponsor	Biologische Heilmittel Heel GmbH
Drug class	Homeopathic combination remedy
Modality	Small molecule
Therapeutic area	Rheumatology / Musculoskeletal / Pain Management
Phase	Phase 3

Mechanism of action

These injectable solutions contain a blend of homeopathic dilutions of botanical extracts (arnica, calendula, hypericum, echinacea, and others) and mineral compounds intended to reduce inflammation, promote tissue repair, and support immune function. The exact molecular mechanisms are not well-characterized by conventional pharmacology, as these are traditional homeopathic formulations used in integrative medicine for musculoskeletal and degenerative conditions.

Approved indications

Traumatic injuries, contusions, and musculoskeletal trauma (Traumeel)
Degenerative joint disease and osteoarthritis (Zeel)
Rheumatoid arthritis and inflammatory joint conditions

Common side effects

Local injection site reactions
Allergic reactions to botanical components
Mild systemic symptoms

Key clinical trials

Study of Intra-articular Injections vs Placebo in Patients With Pain From Osteoarthritis of the Knee (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:

Traumeel® / Zeel® Injectable Solution CI brief — competitive landscape report
Traumeel® / Zeel® Injectable Solution updates RSS · CI watch RSS
Biologische Heilmittel Heel GmbH portfolio CI

Frequently asked questions about Traumeel® / Zeel® Injectable Solution

What is Traumeel® / Zeel® Injectable Solution?

Traumeel® / Zeel® Injectable Solution is a Homeopathic combination remedy drug developed by Biologische Heilmittel Heel GmbH, indicated for Traumatic injuries, contusions, and musculoskeletal trauma (Traumeel), Degenerative joint disease and osteoarthritis (Zeel), Rheumatoid arthritis and inflammatory joint conditions.

How does Traumeel® / Zeel® Injectable Solution work?

Traumeel and Zeel are homeopathic combination remedies that modulate inflammatory and immune responses through multiple plant and mineral constituents.

What is Traumeel® / Zeel® Injectable Solution used for?

Traumeel® / Zeel® Injectable Solution is indicated for Traumatic injuries, contusions, and musculoskeletal trauma (Traumeel), Degenerative joint disease and osteoarthritis (Zeel), Rheumatoid arthritis and inflammatory joint conditions.

Who makes Traumeel® / Zeel® Injectable Solution?

Traumeel® / Zeel® Injectable Solution is developed by Biologische Heilmittel Heel GmbH (see full Biologische Heilmittel Heel GmbH pipeline at /company/biologische-heilmittel-heel-gmbh).

Is Traumeel® / Zeel® Injectable Solution also known as anything else?

Traumeel® / Zeel® Injectable Solution is also known as Traumeel, Zeel.

What drug class is Traumeel® / Zeel® Injectable Solution in?

Traumeel® / Zeel® Injectable Solution belongs to the Homeopathic combination remedy class. See all Homeopathic combination remedy drugs at /class/homeopathic-combination-remedy.

What development phase is Traumeel® / Zeel® Injectable Solution in?

Traumeel® / Zeel® Injectable Solution is in Phase 3.

What are the side effects of Traumeel® / Zeel® Injectable Solution?

Common side effects of Traumeel® / Zeel® Injectable Solution include Local injection site reactions, Allergic reactions to botanical components, Mild systemic symptoms.

Drug class: All Homeopathic combination remedy drugs
Manufacturer: Biologische Heilmittel Heel GmbH — full pipeline
Therapeutic area: All drugs in Rheumatology / Musculoskeletal / Pain Management
Indication: Drugs for Traumatic injuries, contusions, and musculoskeletal trauma (Traumeel)
Indication: Drugs for Degenerative joint disease and osteoarthritis (Zeel)
Indication: Drugs for Rheumatoid arthritis and inflammatory joint conditions
Also known as: Traumeel, Zeel

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