Last reviewed 2026-05-24 · How we verify

oxytetracycline, taro elixir

Laboratorios Goulart S.A. · Phase 3 active Small molecule Under review Quality 0/100

oxytetracycline, taro elixir is a tetracycline antibiotic Small molecule drug developed by Laboratorios Goulart S.A.. It is currently in Phase 3 development for Respiratory tract infections, Skin infections, Gastrointestinal infections.

Oxytetracycline is a broad-spectrum antibiotic that inhibits protein synthesis by binding to the 30S ribosomal subunit.

Oxytetracycline, taro elixir is a small molecule that inhibits the bacterial 70S ribosome. It is used to treat conditions such as acne vulgaris II or III degree and boils, as demonstrated in clinical trials.

Likelihood of approval

60.3% 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).
Anti-infectives pathway favourability +2.0pp
Microbiological endpoints + non-inferiority designs raise approval rates above baseline.

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	oxytetracycline, taro elixir
Sponsor	Laboratorios Goulart S.A.
Drug class	tetracycline antibiotic
Target	30S ribosomal subunit
Modality	Small molecule
Therapeutic area	Infectious disease
Phase	Phase 3

Mechanism of action

This binding prevents the attachment of aminoacyl-tRNA to the ribosomal acceptor site, thereby inhibiting peptide bond formation and ultimately leading to the death of the bacterial cell. Oxytetracycline is effective against a wide range of bacteria, including those that cause respiratory tract infections, skin infections, and gastrointestinal infections.

Approved indications

Respiratory tract infections
Skin infections
Gastrointestinal infections

Common side effects

Nausea
Vomiting
Diarrhea
Abdominal pain
Allergic reactions

Key clinical trials

Open and Comparative Study to Measure Tolerability and Efficacy of Taro Elixir (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:

oxytetracycline, taro elixir CI brief — competitive landscape report
oxytetracycline, taro elixir updates RSS · CI watch RSS
Laboratorios Goulart S.A. portfolio CI

Frequently asked questions about oxytetracycline, taro elixir

What is oxytetracycline, taro elixir?

oxytetracycline, taro elixir is a tetracycline antibiotic drug developed by Laboratorios Goulart S.A., indicated for Respiratory tract infections, Skin infections, Gastrointestinal infections.

How does oxytetracycline, taro elixir work?

Oxytetracycline is a broad-spectrum antibiotic that inhibits protein synthesis by binding to the 30S ribosomal subunit.

What is oxytetracycline, taro elixir used for?

oxytetracycline, taro elixir is indicated for Respiratory tract infections, Skin infections, Gastrointestinal infections.

Who makes oxytetracycline, taro elixir?

oxytetracycline, taro elixir is developed by Laboratorios Goulart S.A. (see full Laboratorios Goulart S.A. pipeline at /company/laboratorios-goulart-s-a).

What drug class is oxytetracycline, taro elixir in?

oxytetracycline, taro elixir belongs to the tetracycline antibiotic class. See all tetracycline antibiotic drugs at /class/tetracycline-antibiotic.

What development phase is oxytetracycline, taro elixir in?

oxytetracycline, taro elixir is in Phase 3.

What are the side effects of oxytetracycline, taro elixir?

Common side effects of oxytetracycline, taro elixir include Nausea, Vomiting, Diarrhea, Abdominal pain, Allergic reactions.

What does oxytetracycline, taro elixir target?

oxytetracycline, taro elixir targets 30S ribosomal subunit and is a tetracycline antibiotic.

Drug class: All tetracycline antibiotic drugs
Target: All drugs targeting 30S ribosomal subunit
Manufacturer: Laboratorios Goulart S.A. — full pipeline
Therapeutic area: All drugs in Infectious disease
Indication: Drugs for Respiratory tract infections
Indication: Drugs for Skin infections
Indication: Drugs for Gastrointestinal infections

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