Achromycin V

(Tetracycline)

ApprovedSmall molecule

Tetracycline is an antibiotic that stops bacteria from growing and spreading. It treats various bacterial infections including respiratory tract infections, skin infections, and certain infections spread by ticks or animals, and is also used with other medications to treat acne.[2] Achromycin V is currently approved and in use across 20 indications[4].[1]

Achromycin V is one of 343 small molecule programs targeting Bacterial Disease. It is currently in Approved.

Indications

Total Trials

Active Trials

342

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Pipeline

Status by Indication[4][1]

Indication

Bacterial DiseaseActive, not recruiting

PneumothoraxActive, not recruiting

AllergyActive, not recruiting

Non-Hodgkins LymphomaApproved

AmeloblastomaActive, not recruiting

Bone DiseaseActive, not recruiting

AcneActive, not recruiting

Dry Eye SyndromeActive, not recruiting

Gastric Mucosa-Associated Lymphoid Tissue LymphomaApproved

SepsisActive, not recruiting

Bacterial DiseaseApproved

Active, not recruiting

PneumothoraxPreclinical

Active, not recruiting

AllergyApproved

Active, not recruiting

Non-Hodgkins LymphomaApproved

Approved

AmeloblastomaPreclinical

Active, not recruiting

Bone DiseasePhase 2/Phase 3

Active, not recruiting

AcnePhase 1

Active, not recruiting

Dry Eye SyndromePreclinical

Active, not recruiting

Gastric Mucosa-Associated Lymphoid Tissue LymphomaApproved

Approved

SepsisPreclinical

Active, not recruiting

Showing 10 of 20 indications

Competition

Competitive Landscape

1931 competitors in COVID-19

#DrugCompanyPhaseTrials

Achromycin V

WWyeth-Lederle Vaccines

Approved

37 2

Spikevax

Moderna

Preclinical

21 3

Bnt162b2

BioNTech

Preclinical

29 4

COVID-19 Vaccine

Moderna

Preclinical

27 5

Biaxin

AbbVie

Preclinical

2 6

Stivarga

Bayer

Preclinical

1 7

Aimovig

Amgen

Preclinical

1 8

Aldactone

Pfizer

Preclinical

1 9

Nexavar

Bayer

Preclinical

1 10

Singulair

AstraZeneca

Preclinical

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q3 2026

Post-ApprovalRecruiting

Bismuth Quadruple Therapy

NCT07139366

Clinical

Trials by Indication[1]

Helicobacter Pylori Infection5 trials

High Dose Amoxicillin Versus Tetracycline as Second-line Treatment of Resistant Helicobacter Pylori Infection

Completed·SShanghai Jiao Tong University School of Medicine·Phase 4·NCT02175927·312 enrolled

Levoﬂoxacin and Bismuth-containing Therapy Versus Quadruple Therapy as Second-line Treatment of Resistant Helicobacter Pylori Infection

Completed·SShanghai Jiao Tong University School of Medicine·Phase 4·NCT01742429·200 enrolled

Empirical Rescue Therapies of Helicobacter Pylori Infection

Completed·SShanghai Jiao Tong University School of Medicine·Phase 4·NCT01668927·424 enrolled

Show 2 more trials

Susceptibility-Guided Therapy for Helicobacter Pylori Infection Treatment

Unknown status·SShanghai Zhongshan Hospital·Phase 4·NCT05250050·388 enrolled

Non-invasive Test-guided Tailored Therapy Versus Empiric Treatment for Helicobacter Pylori Infection.

Unknown status·UUniversity of Bari·Phase 3·NCT04107194·362 enrolled

Helicobacter Pylori Eradication4 trials

Helicobacter Pylori Eradication and Follow-up

Recruiting·SShanghai Zhongshan Hospital·Phase 4·NCT05061732·4,447 enrolled

Comparison of 7-day and 14-day Bismuth Based Quadruple Therapy for Secondary Helicobacter Pylori Eradication

Completed·—·Phase 4·NCT00841854·199 enrolled

Bismuth-containing Quadruple Therapy for Helicobacter Pylori Eradication

Completed·SShandong University·Phase 4·NCT05049902·1,300 enrolled

Show 1 more trial

Bismuth-containing Quadruple Therapy for Helicobacter Pylori Eradication: A Randomized Clinical Trial of 10 and 14 Days

Unknown status·SShandong University·Phase 4·NCT04901117·1,300 enrolled

Helicobacter3 trials

Helicobacter Rescue Therapy With Vonorazon and Amoxicillin Dual Therapy Versus Bismuth-containing Quadruple Therapy

Completed·YYongquan Shi·Phase 4·NCT06168084·688 enrolled

Helicobacter Rescue Therapy With High-dose Esomeprazole and Amoxicillin Dual Therapy Versus Bismuth-containing Quadruple Therapy

Completed·XXijing Hospital of Digestive Diseases·Phase 4·NCT04678492·658 enrolled

Helicobacter Rescue Therapy With Berberine Plus Amoxicillin Quadruple Therapy Versus Tetracycline Plus Furazolidone Quadruple Therapy

Completed·XXijing Hospital of Digestive Diseases·Phase 4·NCT03609892·658 enrolled

Helicobacter Pylori3 trials

Compare Sequential and Quadruple Therapy for the Eradication of Helicobacter Pylori in Korea

Completed·SSeoul National University Bundang Hospital·N/A·NCT02159976·390 enrolled

Antimicrobial Susceptibility Testing Guided Triple Therapy in Salvage Helicobacter Pylori Treatment

Unknown status·YYanqing Li·Phase 4·NCT03139253·120 enrolled

Doxycycline for Helicobacter Pylori Rescue Treatment

Recruiting·SShanghai Jiao Tong University School of Medicine·Phase 4·NCT05874570·368 enrolled

H Pylori Infection2 trials

Genotypic Resistance Guided Therapy for Refractory H. Pylori Infection

Unknown status·NNational Taiwan University Hospital·Phase 4·NCT03555526·320 enrolled

The Efficacy of the 7 Days Tailored Therapy as 2nd Rescue Therapy for Eradication of H. Pylori Infection

Terminated·SSeoul National University Bundang Hospital·N/A·NCT02359331·370 enrolled

17 more indications

Treatment2 trials

Intralesional Tetracycline Injection in the Treatment of Chalazia

Withdrawn·TThe Cleveland Clinic·Phase 1·NCT01763437

Tetracycline Treatment Tolerability Trial

Enrolling by invitation·JJohns Hopkins University·Phase 2·NCT05219929·60 enrolled

Second-line Treatment2 trials

Long-term Follow up Helicobacter Pylori Reinfection Rate After Second-Line Treatment: Bismuth-Containing Quadruple Therapy Versus Moxifloxacin-Based Triple Therapy

Completed·SSeoul National University Bundang Hospital·Phase 4·NCT01792700·648 enrolled

Sequential Versus Quadruple Therapy in the Second-line Treatment

Unknown status·NNational Taiwan University Hospital·Phase 4·NCT03208426·240 enrolled

Acne1 trial

Weekly Isotretinoin vs Tetracycline for Moderate Acne

Recruiting·MMedical University of South Carolina·Phase 1·NCT06225570·50 enrolled

Randomized Controlled Trial1 trial

Tegoprazan-Based Therapies for H. Pylori Eradication: A Randomized Controlled Trial

Completed·ZZhongshan Hospital (Xiamen), Fudan University·N/A·NCT06977841·640 enrolled

Osteoporosis1 trial

Effects of Teriparatide or Denosumab on Bone in Postmenopausal Women With Osteoporosis

Completed· Eli Lilly logo

Eli Lilly·Phase 4·NCT01753856·69 enrolled

Keratosis1 trial

Effects of Antimicrobials on the Altered Skin Flora in Arsenical Keratosis

Unknown status·—·Phase 2·NCT03632733·30 enrolled

Bone Disease1 trial

Bone Disease in Severely Burned Children

Terminated·TThe University of Texas Medical Branch, Galveston·Phase 2/3·NCT00591162·254 enrolled

Bismuth Quadruple Therapy1 trial

Saccharomyces Boulardii Combined With Bismuth Quadruple Therapy for Helicobacter Pylori Rescue Treatment

Recruiting·YYongquan Shi·Phase 4·NCT07139366·1,248 enrolled

Rescue Therapy for Helicobacter Pylori1 trial

Rescue Therapy for Helicobacter Pylori Infection

Completed·SShanghai Jiao Tong University School of Medicine·Phase 4·NCT05874544·360 enrolled

Oral1 trial

Evaluate the PK of Multiple Oral Doses of Tegoprazan, Metronidazole, Tetracycline and Bismuth in Healthy Volunteers

Completed·HHK inno.N Corporation·Phase 1·NCT04066257·32 enrolled

Prophylaxis1 trial

Tetracycline as a Prophylaxis for Rash in Patients With NSCLC Receiving Treatment With BIBW2992 (Afatinib)

Completed·IInstituto Nacional de Cancerologia de Mexico·Phase 2·NCT01880515·107 enrolled

Allergy1 trial

Tailored Therapy for Helicobacter Pylori Treatment in Patients With Penicillin Allergy

Completed·SShanghai Jiao Tong University School of Medicine·Phase 4·NCT03708848·112 enrolled

Azithromycin1 trial

Study of Azithromycin to Prevent Recurrent Trichiasis Following Surgery in Ethiopia

Completed·JJohns Hopkins University·Phase 4·NCT00347776·1,452 enrolled

Sepsis1 trial

Topical Antisepsis in Head and Neck Cancer Surgery

Completed·MMedical College of Wisconsin··NCT04721626·25 enrolled

Paronychia1 trial

Effect of Zanthoxylum Nitidum Tincture for Paronychia Caused by Afatinib

Unknown status·GGuangzhou University of Traditional Chinese Medicine·N/A·NCT03908892·110 enrolled

Pneumothorax1 trial

Effect of Tetracycline Pleurodesis on Prevention of Primary Spontaneous Pneumothorax Recurrence

Completed·IIsfahan University of Medical Sciences·N/A·NCT03634605·50 enrolled

Unspecified2 trials

Sanitation, Water, and Instruction in Face-washing for Trachoma I/II

Completed·UUniversity of California, San Francisco·Phase 3·NCT02754583·47,605 enrolled

Tetracycline Versus Doxycycline for HP Rescue Therapy

Unknown status·SShanghai Zhongshan Hospital·Phase 4·NCT05018923·242 enrolled

Regulatory

FDA Approval Timeline[5]

Jan 1, 1982

TOPICYCLINE

NDA NDA050493

Jan 1, 1982

ACHROMYCIN V

NDA NDA050278

Jan 1, 1982

ACHROMYCIN

NDA NDA050266

Jan 1, 1982

ACHROMYCIN

NDA NDA050268

Jan 1, 1982

ACHROMYCIN V

NDA NDA050263

Jan 1, 1982

ACHROMYCIN

NDA NDA050273

Mar 25, 1994

ACTISITE

NDA NDA050653

Sources

References

[1]
ClinicalTrials.gov — 37 trial records for Tetracycline. U.S. National Library of Medicine, National Institutes of Health.
[2]
MedlinePlus Drug Information — Achromycin V drug information. U.S. National Library of Medicine, National Institutes of Health.
[3]
ChEMBL — Tetracycline compound record. European Bioinformatics Institute (EMBL-EBI).
[4]
Open Targets Platform — Drug–disease associations for Tetracycline. EMBL-EBI & Wellcome Sanger Institute.
[5]
OpenFDA — FDA approval records (NDA NDA050653). U.S. Food & Drug Administration.
[6]
SEC EDGAR — Wyeth-Lederle Vaccines company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: Bacterial 70s Ribosome Inhibitor; Bacterial 70s Ribosome Inhibitor; Bacterial 70s Ribosome Inhibitor[3]
Modality: Small molecule[3]
Highest Phase: Approved[1]
Company: WWyeth-Lederle Vaccines

Achromycin V

Status by Indication[4][1]

Competitive Landscape

Expected Milestones

Q3 2026

Trials by Indication[1]

Helicobacter Pylori Infection5 trials

Helicobacter Pylori Eradication4 trials

Helicobacter3 trials

Helicobacter Pylori3 trials

H Pylori Infection2 trials

Treatment2 trials

Second-line Treatment2 trials

Acne1 trial

Randomized Controlled Trial1 trial

Osteoporosis1 trial

Keratosis1 trial

Bone Disease1 trial

Bismuth Quadruple Therapy1 trial

Rescue Therapy for Helicobacter Pylori1 trial

Oral1 trial

Prophylaxis1 trial

Allergy1 trial

Azithromycin1 trial

Sepsis1 trial

Paronychia1 trial

Pneumothorax1 trial

Unspecified2 trials

FDA Approval Timeline[5]

References

Drug Info

Quick Facts

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