PTS

Chr 11AR

6-pyruvoyltetrahydropterin synthase

Also known as: PTPS

The enzyme encoded by this gene catalyzes the elimination of inorganic triphosphate from dihydroneopterin triphosphate, which is the second and irreversible step in the biosynthesis of tetrahydrobiopterin from GTP. Tetrahydrobiopterin, also known as BH(4), is an essential cofactor and regulator of various enzyme activities, including enzymes involved in serotonin biosynthesis and NO synthase activity. Mutations in this gene result in hyperphenylalaninemia. [provided by RefSeq, Oct 2008]

OMIMResearchGenerating clinical summary…
LOFmechanismARLOEUF 1.691 OMIM phenotype
Clinical SummaryPTS
🧬
Gene-Disease Validity (ClinGen)
BH4-deficient hyperphenylalaninemia A · ARDefinitive

Definitive — sufficient evidence for diagnostic panels

Population Constraint (gnomAD)
Low constraint (pLI 0.00) — loss-of-function variants are relatively tolerated in the population.
📋
ClinVar Variants
113 unique Pathogenic / Likely Pathogenic· 70 VUS of 374 total submissions
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Clinical Trials
12 active or recruiting trials — potential therapeutic options may be available

Population Genetics & Constraint

gnomAD v4 — loss-of-function & missense intolerance

Tolerant — LoF & missense variants common in population
LoF Constraint?
1.69LOEUF
pLI 0.000
Z-score 0.07
OE 0.97 (0.571.69)
Tolerant

Highly tolerant — LoF variants common in population

Missense Constraint?
0.13Z-score
OE missense 0.96 (0.801.16)
76 obs / 79.1 exp
Tolerant

Mild missense constraint

Observed / Expected Ratios?
LoF OE?0.97 (0.571.69)
00.351.4
Missense OE?0.96 (0.801.16)
00.61.4
Synonymous OE?1.22
01.21.6
LoF obs/exp: 8 / 8.2Missense obs/exp: 76 / 79.1Syn Z: -0.93
Curated Mechanism (G2P)Gene2Phenotype (DDG2P) ↗
definitivePTS-related 6-pyruvoyltetrahydropterin synthase deficiencyLOFAR

This gene — mechanism propensity

Predictions shown for reference only — model trained on dominant genes, not applicable to AR conditions.

DN
0.7035th %ile
GOF
0.4874th %ile
LOF
0.4332th %ile

The Badonyi & Marsh prediction model was trained exclusively on dominant disease genes. Predictions are not reliable for genes with autosomal recessive inheritance and are shown at reduced opacity for reference only.

Predictions from Badonyi M, Marsh JA. PLoS ONE. 2024;19(8):e0307312. Mechanism ranking also informed by gnomAD constraint, ClinVar, and ClinGen data.

ClinVar Variant Classifications

374 submitted variants in ClinVar

Classification Summary

Pathogenic41
Likely Pathogenic72
VUS70
Likely Benign149
Benign15
Conflicting19
41
Pathogenic
72
Likely Pathogenic
70
VUS
149
Likely Benign
15
Benign
19
Conflicting

Curated Variants Distribution

Classified variants from ClinVar · 5 ACMG categories

ClassificationLoFMissense + InframeNon-codingSynonymousTotal
Pathogenic
17
15
9
0
41
Likely Pathogenic
33
36
2
1
72
VUS
1
58
9
2
70
Likely Benign
0
1
92
56
149
Benign
0
0
14
1
15
Conflicting
19
Total5111012660366

LoF = frameshift, stop gained/lost, canonical splice · Counts from ClinVar esearch · Updated hourly

View in ClinVar →

13 pathogenic / likely-pathogenic (of 20) ClinVar copy-number / structural variants overlap PTS — these span large chromosomal regions, not the gene specifically, and are excluded from the counts above. Explore in CNV tools →

Protein Context — Lollipop Plot

PTS · protein map & ClinVar variants

Showing all ClinVar variants across the protein. Search a specific variant to highlight its position.

Clinical Trials

Active and recruiting trials from ClinicalTrials.gov

Muscle Invasive Bladder Cancer

Open-Label, Randomised, Multi-Drug, Biomarker-Directed, Phase 1b Study in Pts w/ Muscle Invasive Bladder Cancer

ACTIVE NOT RECRUITING
NCT02546661Phase PHASE1AstraZenecaStarted 2016-12-28
AZD4547MEDI4736Olaparib
Locally Advanced Urothelial CarcinomaMetastatic Urothelial CarcinomaStage III Bladder Cancer AJCC v8

Testing the Addition of Tazemetostat to the Immunotherapy Drug, Pembrolizumab (MK-3475), in Advanced Urothelial Carcinoma

ACTIVE NOT RECRUITING
NCT03854474Phase PHASE1, PHASE2National Cancer Institute (NCI)Started 2019-11-18
Biospecimen CollectionComputed TomographyMagnetic Resonance Imaging
ALK Gene RearrangementALK Gene TranslocationALK Positive

Crizotinib in Treating Patients With Stage IB-IIIA Non-small Cell Lung Cancer That Has Been Removed by Surgery and ALK Fusion Mutations (An ALCHEMIST Treatment Trial)

ACTIVE NOT RECRUITING
NCT02201992Phase PHASE3ECOG-ACRIN Cancer Research GroupStarted 2015-03-23
Clinical ObservationCrizotinibLaboratory Biomarker Analysis
Colorectal Neuroendocrine Tumor G1Gastric Neuroendocrine Tumor G1Neuroendocrine Neoplasm

Octreotide Acetate and Recombinant Interferon Alfa-2b or Bevacizumab in Treating Patients With Metastatic or Locally Advanced, High-Risk Neuroendocrine Tumor

ACTIVE NOT RECRUITING
NCT00569127Phase PHASE3National Cancer Institute (NCI)Started 2007-12-01
BevacizumabLaboratory Biomarker AnalysisOctreotide Acetate
Metastatic Renal Cell CarcinomaSarcomatoid Renal Cell CarcinomaStage II Renal Cell Cancer AJCC v7

Nivolumab in Treating Patients With Localized Kidney Cancer Undergoing Nephrectomy

ACTIVE NOT RECRUITING
NCT03055013Phase PHASE3National Cancer Institute (NCI)Started 2017-04-28
NephrectomyNivolumabPatient Observation
SeizuresTraumatic Brain InjuriesTraumatic Brain Injury (TBI) Patients

Early Post-Traumatic Seizures Prevention Trial (E-PTS Trial)

RECRUITING
NCT07072624Phase PHASE4All India Institute of Medical Sciences, JodhpurStarted 2025-07-23
PhenytoinLevetiracetamPlacebo
LeukemiaAcute Lymphoblastic Leukemia

Precursor B Cell Acute Lymphoblastic Leukemia (B-ALL) Treated With Autologous T Cells Genetically Targeted to the B Cell Specific Antigen CD19

ACTIVE NOT RECRUITING
NCT01044069Phase PHASE1Memorial Sloan Kettering Cancer CenterStarted 2010-01-05
gene-modified T cells targeted
Acute Promyelocytic Leukemia (APL)

Oral Arsenic With ATRA for Newly Diagnosed Patients With Acute Promyelocytic Leukemia

RECRUITING
NCT06982274Phase PHASE2Instituto do Cancer do Estado de São PauloStarted 2023-10-20
Realgar-Indigo Naturalis Formulation
Clinical Stage III Cutaneous Melanoma AJCC v8Clinical Stage IV Cutaneous Melanoma AJCC v8Metastatic Cutaneous Melanoma

Physician/Patient Choice of Either High-Dose Recombinant Interferon Alfa-2B or Ipilimumab, Versus Pembrolizumab in Treating Patients With Stage III-IV High Risk Melanoma That Has Been Removed by Surgery

ACTIVE NOT RECRUITING
NCT02506153Phase PHASE3National Cancer Institute (NCI)Started 2015-11-10
Biospecimen CollectionComputed TomographyIpilimumab
Recurrent Lung Non-Small Cell CarcinomaStage IV Lung Cancer AJCC v8

Comparing Combinations of Targeted Drugs for Advanced Non-Small Cell Lung Cancer That Has EGFR and MET Gene Changes (A Lung-MAP Treatment Trial)

RECRUITING
NCT05642572Phase PHASE2SWOG Cancer Research NetworkStarted 2023-05-05
Biospecimen CollectionCapmatinibComputed Tomography
Long Term Safety of Patients Receiving CAR-T in an Eligible Clinical Trial or Managed Access Program

CAR-T Long Term Follow Up (LTFU) Study

RECRUITING
NCT02445222Phase PHASE3Novartis PharmaceuticalsStarted 2015-11-02
Previously treated CAR-T patients
Bladder Cancer

Investigator Grant (IG) 2022 27746

RECRUITING
NCT06341478Phase NAIRCCS San RaffaeleStarted 2024-03-15
various neoadjuvant therapies